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FDA Scientists Say Officials Engaged in Misconduct
Posted: 20 November 2008
A group of scientists at the US Food and Drug Administration (FDA) says that officials at the agency engaged in “serious misconduct” by ignoring the concerns of agency scientists and approving unsafe or ineffective medical devices. The US House Committee on Energy and Commerce plans to investigate the accusations, which surfaced last month when eight scientists in FDA’s Center for Devices and Radiological Health wrote to Committee Chairman John Dingell (D-MI). Read the article
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Pharma Execs Say R&D is Top Priority
Posted: 20 November 2008
A survey of executives at the world’s top pharmaceutical firms reveals that the dearth of new drugs currently in the development pipeline is their major concern and that R&D is their top priority. Although many drugmakers have focused on cost-cutting efforts in recent years and the strategy has been effective in the short term, the survey seems to indicate a collective change in thinking. Read the article
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Counterfeit Drugs Seized in Global Efforts
Posted: 20 November 2008
Interpol, in cooperation with regulatory agencies around the world, has seized millions of dollars worth of counterfeit medicines. In Southeast Asia, counterfeit malaria, HIV and tuberculosis drugs were seized and 27 arrests made in the culmination of a five-month investigation across Cambodia, China, Laos, Myanmar, Singapore, Thailand and Vietnam. Meanwhile, the Permanent Forum on International Pharmaceutical Crime and the World Health Organization worked with Interpol to conduct raids in Canada, Germany, Ireland, Israel, New Zealand, Singapore, Switzerland, the US and the UK of businesses suspected of illegally supplying drugs over the internet. Read the article
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In UK, Debate Over Medical Research and Privacy
Posted: 20 November 2008
UK officials want to allow researchers access to National Health Service (NHS) records to help them identify patients who might be willing to take part in clinical trials. Critics of the plan say it would undermine the privacy of millions of patients and call the proposal "ethically unacceptable." Advocates of the plan say the privacy concerns are unwarranted. Read the article
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Obama Taps Daschle for HHS Spot
Posted: 20 November 2008
US President-elect Barack Obama has selected former South Dakota Senator Tom Daschle as his Secretary of Health and Human Services. Observers say the selection of Daschle, a reform advocate and high-profile pick for a traditionally lower-profile cabinet post, signals that healthcare reform will be a priority for the Obama administration. Read the article
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FDA Chief Says Agency Must Adapt
Posted: 13 November 2008
Advances in medical technology will dramatically change the way healthcare products are tested and approved, forcing companies and regulators to work differently in the future, says the commissioner of the US Food and Drug Administration. Speaking to a group of business students in Philadelphia, FDA Commissioner Andrew von Eschenbach said that advances in personalized medicine will mean regulatory agencies like FDA will have to focus more on issues such as how people with specific genetic makeups respond to certain drugs. He emphasized how dramatic the changes due to advances in technology will be, saying “the future will look no more like the past than a butterfly looks like a caterpillar.” Read the article
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UK Regulators Issue Warning on Anti-Smoking Drug
Posted: 13 November 2008
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning that "depression and suicide-related events" have been reported in patients using Pfizer’s anti-smoking aid Varenicline, also known by the brand names Chantix in the US and Champix in Europe and elsewhere. According the MHRA website, "patients who are taking Varenicline who develop suicidal thoughts or who develop agitation, depressed mood, or changes in behavior that are of concern...should stop their treatment and contact their doctor immediately." Read the article
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Observers Speculate About Obama Healthcare Agenda
Posted: 13 November 2008
As speculation continues about whom US President-elect Barack Obama may choose to run key agencies, many are also eagerly anticipating which healthcare-related issues may be among the new administration’s top priorities. Observers around the world are watching for clues as to what Obama may do in areas such as stem-cell research and drug reimportation. Also, the folks at Pharma Marketing Newswant to hear from you on your choice for the next commissioner of the US Food and Drug Administration. Read the article
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Encouraging Results for New Generation Stent
Posted: 13 November 2008
A new generation of stents shows promise in avoiding some of the problems associated with earlier drug-eluting stents in patients with heart disease. Drug-eluting stents are designed to prop open narrowed arteries while inhibiting excessive cell growth, but they also interfere with the healing process and have been associated with late-stent thrombosis, or stent-related blood clots. This new stent works differently. It is coated with an antibody that attracts cells lining artery walls, allowing them to cover the stent, speeding the healing process and keeping arteries open longer. Two new European studies have shown encouraging results for this new type of stent. Read the article
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Smart Communications on Regulatory Interactions Key for Biotechs
Posted: 13 November 2008
Over-communicating about interactions with regulatory agencies is among the eight mistakes biotech companies make that can hurt their valuation, says an industry expert. In a conversation with FierceBiotech, biotech communications consultant, Douglas MacDougall, lists pitfalls for biotechs to sidestep to keep company stock value where it needs to be and avoid creating inappropriate expectations––too high or too low––among investors. Among his advice is to not over-communicate about the company’s contact with regulators. Very little of such contact is subject to public disclosure, and offering too much premature information can fuel ill-informed speculation. Read the article
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Supreme Court Hears Preemption Case
Posted: 6 November 2008
The US Supreme Court heard arguments this week in the case of Wyeth v. Levine, which could determine whether prior federal approval of a given drug preempts liability rulings against drugmakers at the state level. A Vermont court awarded musician Diana Levine a $6.8 million judgment against Wyeth after a misadministration of an anti-nausea drug caused gangrene that resulted in the amputation of part of her arm. In a related story, Pharmalot’s Ed Silverman, writing before the election, says Barack Obama’s victory in the presidential race will spell the end of preemption. Read the article
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UK to Allow Patients to Pay for Drugs NHS Won’t
Posted: 6 November 2008
Patients in the UK will now be allowed to pay privately for expensive drugs not covered by the National Health Service (NHS) without losing their NHS coverage. The announcement from Health Secretary Alan Johnson represents a reversal of the previous policy whereby those deciding to take advantage of medicines deemed by the National Institute of Clinical Excellence to be effective but too expensive for NHS payments were forced to forfeit their NHS coverage entirely. The policy had been the subject of much debate and Johnson acknowledged it was “seen by the majority of people as a cruel procedure.” Read the article
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Obama Win Spurs Speculation on Top Health Aides
Posted: 6 November 2008
With Sen. Barack Obama’s victory in the US Presidential election, talk in Washington has now turned fully to whom he will select for top positions in his administration, including who will be the next heads of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). Names mentioned for the HHS spot include former South Dakota Sen. Tom Daschle, former NIH director Harold Varmus and Democratic National Committee Chair Howard Dean. Speculation about who will succeed Andrew von Eschenbach, who is expected to step down as FDA commissioner, centers on Cleveland Clinic cardiologist Steven Nissen, former Deputy FDA Commissioner Mike Taylor, Duke University cardiologist Robert Califf, lawyer and industry consultant Mary Pendergast and the current director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock. Read the article
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Michigan Voters Pass Stem-Cell Referendum
Posted: 6 November 2008
Michigan voters on Tuesday voted in favor of a proposal to ease restrictions on embryonic stem-cell research in that state. The initiative, known as Proposal 2, passed 53%–47%, and will allow researchers to use stem cells from embryos left over from fertility treatments for disease research. It is currently illegal under Michigan law to destroy an embryo for "nontherapeutic" purposes or to donate an embryo to science. The new measure will amend the state constitution, making it very difficult for the state’s legislature to restrict embryonic stem-cell research in the future. Read the article
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Vytorin Makers Face Lawsuits, Federal Investigation
Posted: 6 November 2008
Merck and Schering-Plough, makers of cholesterol drug Vytorin, are facing numerous lawsuits and an investigation by the US Department of Justice over their marketing and promotion of the drug. The Justice Department notified Merck in September that it is investigating whether the companies’ promotion of Vytorin resulted in false claims to federal healthcare programs. If the companies are found to have violated the False Claims Act, the government could seek to recover federal dollars spent on the drug. Read the article
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FDA Says Delays Caused by New Duties, Staffing Issues
Posted: 30 October 2008
As the US Food and Drug Administration (FDA) continues to miss target dates to act on new drug applications, an official says the reason is that the agency is still understaffed to handle the new duties mandated by Congress last year. "There is a new process we are working through, but hopefully this is a blip in the system," said Dr. John Jenkins, director of FDA's Office of New Drugs. Pharmaceutical companies say the delays may be preventing consumers from getting the best possible treatments. Clearly, the approval back ups are not helping drugmakers’ bottom line either as the industry faces the economic downturn, expiring patents on brand-name medicines and competition from cheaper generic drugs. Read the article
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New Regulatory Approach Favors Biotech, Says Analysis
Posted: 30 October 2008
Smaller biotech companies, more willing and able than large drugmakers to accept postmarket restrictions placed on their new products, are better positioned for winning approval by the US Food and Drug Administration (FDA), says a new analysis in the RPM Report. As part of the Food and Drug Administration Amendments Act of 2007, FDA gained a new tool, Risk Evaluation and Mitigation Strategies (REMS) that allows the agency more flexibility to approve new drugs by imposing additional postmarket restrictions. Drugs approved under REMS typically are limited in the patient population allowed to access the product. Large pharmaceutical companies that spend large amounts of money on marketing and infrastructure aim to sell their products to the broadest possible market in order to recoup their investment. But biotech companies that have not made such massive investments are better positioned to take the incremental steps toward the broader market. Read the article
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Drugmakers Seek Clarity on UK Reporting Law
Posted: 30 October 2008
A number of respondents have told the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) that the law needs to be clearer on exactly when drugmakers must report new information about drug risks and benefits. The respondents, mostly representing industry, are seeking more guidance on what to report and within what timeframe, and to clarify terms such as “promptly” and “due diligence,” used in the current law, the Medicines For Human Use (Marketing Authorisations, etc) Regulations 1994. The new attention to the law follows MHRA’s finding earlier this year that GlaxoSmithKline had failed to inform it in a timely manner about new information it had on the safety of antidepressant Seroxat. Read the article
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FDA Needs 13 Years to Inspect Foreign Plants
Posted: 23 October 2008
A new report by congressional investigators says it would take 13 years for US Food and Drug Administration (FDA) inspectors to visit every manufacturing plant outside the US that makes medications for the American market. The report released this week by the US Government Accountability Office accuses FDA of failing to keep accurate information about overseas manufacturers and lacking in its follow up, and concludes that the agency is a long way from being able to monitor foreign facilities at the same level as domestic plants. On average, US pharmaceutical factories are inspected every 2.7 years, while FDA only inspects a small fraction of the foreign plants making drugs for the US market. Exactly how many foreign manufacturing facilities exist is not known, but various government estimates put the number somewhere between 3,000 and 6,760. FDA inspects an average of 247 each year. Read the article
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Reported Serious Drug Reactions Up Dramatically
Posted: 23 October 2008
The number of serious drug reactions and deaths reported to the US government set a record in the first quarter of this year, according to a health industry watchdog group. The US Food and Drug Administration (FDA) received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, during the three-month period, a 38% increase over the average for the previous four calendar quarters, and the highest for any quarter, according to an analysis by the group ISMP. Serious reactions are defined as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. Two drugs in particular accounted for a disproportionately large share of the latest reports: heparin, the tainted blood thinner from China, and Chantix, an anti-smoking drug from Pfizer Inc. Chantix had the most reports of any drug. Earlier this year, FDA warned that the drug may be linked to psychiatric problems and banned its use for pilots. Read the article
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A Quarter of Biologics Get Safety Warnings
Posted: 23 October 2008
About a quarter of biological medicines approved for the US and European markets since 1995 have drawn safety warnings after entering the market, says a Dutch report out this week. The biologics in question were linked to a range of issues including immune system disorders, infusion reactions, infections and cancer concerns. Biologics are derived from living cells rather than chemicals. Researchers at Utrecht University in the Netherlands tracked regulatory actions involving 174 biological medicines approved in the US and the EU between January 1995 and June 2007 and found that safety-related regulatory actions were taken involving 41 of the medicines, or 24%. Read the article
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GlaxoSmithKline to Cap and Disclose Docs’ Fees
Posted: 23 October 2008
GlaxoSmithKline (GSK) will disclose to the public the advisory fees it pays to doctors and medical researchers, and will cap the payments they can receive. Advisory fees will be capped in the US at $150,000 per year. The announcement by GSK Chief Executive Andrew Witty comes amid growing concern that the common practice of advisory payments may be more of an effort to influence respected opinion leaders in the medical community than a payment for the advice they offer. GSK has recently been the subject of criticism for such payments in both the US and Europe. Read the article
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FDA Behind Voluntary Ban on Kids’ Cold Meds
Posted: 16 October 2008
It has now been learned that the US Food and Drug Administration (FDA) played a key role in last week’s announcement by drugmakers that they would add package warnings against administering cough and cold medicines to children under four years of age. While pediatricians had recommended that the cut-off age be six, FDA nudged manufacturers to make it four. Agency officials made the suggestion to industry representatives in private discussions months before the announcement of the "voluntarily" action. The behind-the-scenes maneuvering is an example of how government health officials and regulated industries can reach an agreement outside the bounds of official regulation. Read the article
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New Research Center Aims to Improve Biotech Drug Production
Posted: 16 October 2008
The Center for Biopharmaceutical Operations at the University of California, Berkeley, slated to open in mid-2009, will focus on improving efficiencies in the complex and costly process of biotech drug production. Ultimately, improved processes and standardization could result in lower drug prices and better access, say the center’s founders. Such drugs are expensive to manufacture as the production is often dependent upon time-intensive, delicate processes. University researchers believe the establishment of the new center will help biotech companies “do significantly better.” Read the article
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Public Needs Better Explanations of Drug Risks, Benefits
Posted: 16 October 2008
Government officials and pharmaceutical industry leaders agreed, during a recent UK forum, that consumers do not adequately understand the risks and potential benefits of the medicines they take, and better explanations are needed. Participants at the Ministerial Industry Strategy Group (MISG) Forum meeting included healthcare product regulators from the UK, Europe and the US, drug industry representatives, patient advocates, economists and academics. The group reported that most consumers have little understanding that there is risk is involved in taking medications and may have expectations of the drugs’ benefits that are too high. Some argue that media accounts have contributed to the hype and misperceptions about available drugs, and the group acknowledges that end users need clearer, more thorough communications to help them weigh the risks and benefits. Read the article
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FDA Ramps Up Public Disclosure of Clinical Trial Results
Posted: 16 October 2008
The US Food and Drug Administration (FDA) is increasing the scope of clinical trials required to report information and results to the public through its website created for that purpose, www.clinicaltrials.gov. The requirement is mandated by the Food and Drug Amendments Act (FDAAA) of 2007. Under the law, registration information on a trial must be posted within 21 days of enrolling the first subject, and changes to a trial must be posted within 30 days. Trial results must be posted within 12 months of the trial’s completion. FDA says it will require registration information for 3,000 drug and biologics trials and 445 trials of medical devices annually, and estimated that nearly 12,000 other voluntary data submissions also will be collected. Read the article
> This topic also is covered in the October issue of Regulatory Focus. RAPS members can access the issue online at www.raps.org/personifyebusiness/MemberCenter/Focus/tabid/307/Default.aspx.
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Drugmakers Call for Price Controls in Europe
Posted: 9 October 2008
The head of the association representing the European pharmaceutical industry has called for price controls that would allow drugmakers to sell medicines cheaply in poorer states without fear of their products being bought and resold at higher prices elsewhere. The practice of parallel trade, where drugs are purchased in low-priced markets and resold in more affluent countries, creates a disincentive for pharmaceutical companies to offer the drugs at affordable prices in poorer markets such as central and eastern Europe. The price control issue was missing from a package of recommendations recently endorsed by European officials. Read the article
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Cough and Cold Meds Add Warning for Young Children
Posted: 9 October 2008
The makers of over-the-counter cough and cold medicines will add package warnings to not administer the drugs to children under four years of age in response to the recommendations of doctors and advisers to the US Food and Drug Administration (FDA) last week. Pediatricians have repeatedly raised questions about the drugs’ effectiveness for young children and voiced concern about the risks of giving them to children. The voluntary labeling change comes less than a week after an FDA advisory panel agreed that there is little evidence indicating that the drugs work. Government officials stopped short of banning the medicines for fear it could prompt parents to give their children drugs meant for adults instead. Read the article
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Study Says Free Drug Samples May Harm Children
Posted: 9 October 2008
A new study published this week says that free drug samples do not help poorer patients and may pose a threat to children. The study, appearing in the journal Pediatrics, analyzed the results of a 2004 survey by the Centers for Disease Control and Prevention on how people receive their healthcare. Part of the survey asked respondents about free drug samples. Researchers found that children in the lowest income group were no more likely to receive free samples than those from families in the highest income group. More troubling, though, was evidence that children are being given drugs that may not be safe. In 2004, the year the survey was administered, more than half a million children were given samples of four drugs that were later required by the US Food and Drug Administration to carry serious safety warnings. This included 38,000 children under age two who received free samples of the eczema drug Elidel, which was later required to include a warning that it was not approved for use in children under two. Read the article
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UK Encourages Drugmakers to Cut Prices for New Drugs
Posted: 9 October 2008
Drugmakers are being encouraged by UK government officials to offer new drugs to patients at lower initial prices in the hope that the National Health Service (NHS) will pay more for the drugs later if they are shown to be effective. The proposal comes in response to the problem of patients being forced to choose between access to NHS-paid treatments and other effective, but more expensive, treatments that the National Institute for Clinical Excellence (NICE) had determined are not cost-effective for NHS to support. Under the proposed plan, companies would initially lower the price of a drug to get it under NICE's threshold for approval with an eye toward raising the price as it gathers increased evidence of its clinical efficacy. Such arrangements have already been put into place for a few drugs and have the support of a number of pharmaceutical executives. Read the article
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Pharma Companies Cut Research Expenditures
Posted: 2 October 2008
Major pharmaceutical manufacturers, facing low returns on investments and dwindling pipelines, are cutting research staff and spending. This week, GlaxoSmithKline became the latest manufacturer to announce job cuts, eliminating 850 research and development positions. Also, Pfizer Inc. announced that it is dropping development efforts for drugs to treat heart disease, obesity and bone health and will concentrate on oncology products and other “high-potential” areas, writes Elizabeth Trotta on thestreet.com. These moves follow a trend toward more focused R&D efforts to improve corporate productivity. Read the article
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Aggressive Patent Protection Stifles Innovation, Says Study
Posted: 2 October 2008
The tendency of companies in the life sciences to aggressively accumulate and defend patents is stifling innovation in biotechnology and healthcare, according to a new international study led by Canadian researchers. The International Expert Group on Biotechnology, Innovation and Intellectual Property, presented the study's findings in London this week, and called for a more collaborative approach in the life sciences. Although the group is not opposed to patent protection, members raised concerns about the confrontational approach taken by many companies and universities and the tendency to amass and defend as many patents as possible. They presented case studies to show that this method was counterproductive, but acknowledged that changing intellectual property laws to promote collaboration is not a realistic goal. Instead, they argue the most effective change would have to come from the life sciences industry itself. Read the article
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New Rules for Combo Products by End of Year, Says FDA
Posted: 2 October 2008
The director of the US Food and Drug Administration’s (FDA) Office of Combination Products said last week at RAPS’ Annual Conference & Exhibition that two new rules governing combination products were expected by the end of this year. Thinh Nguyen told attendees the new regulations will cover Good Manufacturing Practices (GMPs) and adverse event reporting. Manufacturers have been awaiting clarification on GMPs for combination products since FDA issued its draft guidance in 2004. Device manufacturing is governed by the Quality System Regulation, while pharmaceutical manufacturing is governed by Good Manufacturing Practices. The 2004 guidance leaves which set of standards should be considered primary for a combination product open to interpretation. Read the article
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FDA Will Miss FDAAA Deadlines
Posted: 25 September 2008
As the Food and Drug Administration Amendments Act closes in on the first anniversary of its passage, officials at the US Food and Drug Administration (FDA) are telling members of Congress the agency will miss some of the law’s implementation deadlines. FDA is not saying which of the dozen or so approaching deadlines it will not be able to meet but the RPM Report points out three of particular interest to the drug industry: the start of the priority review tropical disease voucher system, a report due to Congress on best practices for communicating the risk-benefit balance to the public and the development of a postmarketing drug safety website. Read the article
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Aggressive Patent Protection Stifles Innovation, Says Study
Posted: 25 September 2008
The tendency of companies in the life sciences to aggressively accumulate and defend patents is stifling innovation in biotechnology and healthcare, according to a new international study led by Canadian researchers. The International Expert Group on Biotechnology, Innovation and Intellectual Property, presented the study's findings in London this week, and called for a more collaborative approach in the life sciences. Although the group is not opposed to patent protection, members raised concerns about the confrontational approach taken by many companies and universities and the tendency to amass and defend as many patents as possible. They presented case studies to show that this method was counterproductive, but acknowledged that changing intellectual property laws to promote collaboration is not a realistic goal. Instead, they argue the most effective change would have to come from the life sciences industry itself. Read the article
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New Rules for Combo Products by End of Year, Says FDA
Posted: 25 September 2008
The director of the US Food and Drug Administration’s (FDA) Office of Combination Products said last week at RAPS’ Annual Conference & Exhibition that two new rules governing combination products were expected by the end of this year. Thinh Nguyen told attendees the new regulations will cover Good Manufacturing Practices (GMPs) and adverse event reporting. Manufacturers have been awaiting clarification on GMPs for combination products since FDA issued its draft guidance in 2004. Device manufacturing is governed by the Quality System Regulation, while pharmaceutical manufacturing is governed by Good Manufacturing Practices. The 2004 guidance leaves which set of standards should be considered primary for a combination product open to interpretation. Read the article
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More Than Half of Studies on Approved Drugs Go Unpublished
Posted: 25 September 2008
A ruling this week by the European Court of Justice requires pharmaceutical companies to meet “ordinary” demand for medicines in markets where drug prices are lower and the potential exists for re-exporting the drugs at a profit. If drugmakers seek to limit sales to such lower-cost markets, they will have to be very careful to ensure that they meet what the court calls "ordinary" orders for medicinal products. The judgment concluded a lengthy legal battle between GlaxoSmithKline and Greek wholesalers. While the judges of Europe’s highest court acknowledged manufacturers’ right "to counter in a reasonable and proportionate way" the threat to their commercial interests through parallel exporting, they sought to ensure access to needed medication by people in markets where regulated prices are low. Read the article
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Smaller Companies More Likely to Face Review Challenges
Posted: 25 September 2008
New research shows that smaller drug and biotech companies, many of which lack regulatory expertise and have not yet had a product approved by the US Food and Drug Administration (FDA), are more likely to undergo multiple review cycles by the agency. So says an analysis of FDA's user fee performance reports by the director of economic analysis at Tufts University’s Center for the Study of Drug Development. The research also shows that Biologic License Applications have higher odds of facing multiple review cycles compared to New Drug Applications. However, fast track status lowered the likelihood of a multi-cycle review. Read the article
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US Lawmakers Examine Deceptive Device Ads
Posted: 18 September 2008
A US Senate panel yesterday heard testimony from experts calling for increased federal scrutiny of direct-to-consumer advertising for medical devices. Such ads for pharmaceuticals are required to provide balanced information about products’ risks and benefits. Medical devices are not subject to the same standard. Critics from organizations such as Consumers’ Union, publisher of Consumer Reports, contend that the stakes for device advertising may actually be higher than for drugs since devices often require invasive, irreversible surgery. A spokesman for the medical device industry says that the rules currently in place are adequate and stresses that the process leading to the surgical implantation of a medical device involves a discussion of risks and benefits with a physician. In testimony, the spokesman called the ads a “powerful education tool.” Read the article
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FDA Bans Imports From Indian Drugmaker
Posted: 18 September 2008
The US Food and Drug Administration (FDA) announced yesterday that it would not allow 28 drugs made by India’s Ranbaxy Laboratories to be imported into the US because of problems cited at two of the company's plants. FDA officials said they do not expect the ban to impact US consumers. One official said the action was warranted because of the seriousness and the extent of violations related to the manufacturing process, but that all of the products the agency has tested have been found to meet FDA specifications and officials do not have any reason to believe they are hazardous. Ranbaxy is India's largest pharmaceutical company and one of the 10 biggest generic drugmakers in the world. Read the article
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Pfizer Website to Help Consumers Consider Risks
posted: 18 September 2008
Pfizer, the world's largest drug company, has launched a new website intended to help consumers sort through the risks and benefits of taking various medications. The move is seen as unusual in light of the criticism often aimed at the pharmaceutical industry by those who say drug marketing is deceptive and generally downplays risks. The site includes sections written for patients and for health professionals, with plain-English explanations, graphics and video clips. Notably, it features a prominent link to information about how to report a drug side effect to the US Food and Drug Administration. The company says it plans to promote the site through partnerships with medical and patient advocacy groups. Read the article
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Drugmakers Obligated to Meet Demand in Low-Cost Markets
Posted: 18 September 2008
A ruling this week by the European Court of Justice requires pharmaceutical companies to meet “ordinary” demand for medicines in markets where drug prices are lower and the potential exists for re-exporting the drugs at a profit. If drugmakers seek to limit sales to such lower-cost markets, they will have to be very careful to ensure that they meet what the court calls "ordinary" orders for medicinal products. The judgment concluded a lengthy legal battle between GlaxoSmithKline and Greek wholesalers. While the judges of Europe’s highest court acknowledged manufacturers’ right "to counter in a reasonable and proportionate way" the threat to their commercial interests through parallel exporting, they sought to ensure access to needed medication by people in markets where regulated prices are low. Read the article
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Relationships Between Docs and Device Cos. Draw Scrutiny
Posted: 11 September 2008
Recent lawsuits and several federal government investigations have brought increasing public scrutiny of the common practice by medical device companies of paying large consulting fees to the doctors who ultimately recommend their products. Medical device manufacturers say their products must be developed in partnership with the doctors who will use them to ensure the products’ safety and effectiveness. Critics charge that the consulting arrangements’ primary purpose is to get doctors to push certain products. There is no question that doctors wield strong influence over the decisions patients make regarding these products and it is not surprising that doctors would recommend products they had a hand in developing. But few patients are likely aware of the large payments doctors often receive from medical device manufacturers for consulting, speakers’ fees, royalties or other expenses. Proposed federal legislation would force companies to publicly disclose these arrangements and their values. A Minneapolis Star Tribune series examines the influence of medical device makers. Read the article: Part I, Part II
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Japanese Drugmakers Expand Abroad
Posted: 11 September 2008
Japanese pharmaceutical companies have responded to government-mandated price cuts and the threat of increased usage of generic drugs at home by increasingly looking overseas. So far in 2008, Japanese drug companies have already spent two and a half times the amount they spent for the whole of 2007 on overseas acquisitions, according to a company that monitors corporate deals. The increased number of deals with foreign companies highlights the pressure on Japanese drugmakers to expand beyond their own borders. While Japan remains the second largest market in the world for prescription drugs, growth has taken a sharp downturn in recent years. In an effort to relieve some rising healthcare costs for an aging population, Japan’s government has imposed official price cuts on patented drugs. Authorities have also begun efforts to stimulate competition in the generics market. Read the article
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FDA to Disclose Drugs Under Investigation
Posted: 11 September 2008
The US Food and Drug Administration (FDA) will begin releasing to the public a list of drugs being investigated due to safety concerns. The list will be updated every three months and the effort comes in response to complaints by drug companies, physicians and patients. FDA’s list will specify the investigated drugs and the nature of the adverse events reported but will not go into further detail. Although the new policy, which is mandated by changes to federal law, may unintentionally alarm some patients, FDA officials stress that being on the list does not indicate that a drug is unsafe, but rather that the agency is looking into it. The vast majority of the 482,154 unsolicited reports to FDA's Adverse Event Reporting System (AERS) last year were false alarms. FDA officials say they are still considering how to inform the public when a listed drug is exonerated through an investigation. Read the article
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Judge Orders Confidential Drug Records Unsealed
Posted: 11 September 2008
Citing “fundamental questions” about the way drugs are approved for new uses, a federal judge has ordered confidential documentation regarding Eli Lilly and Company’s antipsychotic drug Zyprexa be unsealed. The decision came as part of a ruling that gave class-action status to a case brought by insurance companies, pension funds and unions against Lilly in an effort to force the drugmaker to reimburse them for billions of dollars spent on the drug. The suit argues that Lilly hid the drug’s side effects and marketed it for unapproved uses. Read the article
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Evidence of Drug Effectiveness an Ongoing Pursuit
Posted: 4 September 2008
In the wake of studies that seem to indicate popular cholesterol-lowering drug Vytorin is not as effective as first believed, some critics are calling for the US Food and Drug Administration (FDA) to require more extensive trials and more data before approving such new medicines. FDA approved Vytorin in 2002 on the basis of a few clinical trials involving a relatively small number of patients and offering no evidence that it actually reduced heart attacks or cardiovascular disease. But the lack of conclusive data is not unusual and, in fact, many drugs are approved on the basis of what are known as surrogate endpoints that provide strong evidence that a drug will have the ultimate, intended effect. As some drugs approved this way have proven to be ineffective or even dangerous once on the market, some are calling for FDA to set the approval bar higher. Indeed, the agency does seem to be taking a more conservative approach lately. Read the article
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For R&D, Drugmakers Go To College
Posted: 4 September 2008
Facing a shortage of promising new drugs in the late stages of development as well as increasing competition from generics, many drugmakers have turned to partnerships with academic institutions to drive the science of new drug development. While pharmaceutical companies have a long history of partnering with academic institutions, these relationships have become more entrepreneurial in nature than in the past, where a very specific line of research was typically carried out exclusively by a university scientist. Today’s partnerships often involve teams of university and industry scientists working together to advance new drug discovery and stimulate basic research. Read the article
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Monitoring Results in New Drug Safety Warnings for Children
Posted: 4 September 2008
A drug monitoring initiative of the US Food and Drug Administration to encourage testing of medicines in children found that one-third of the scrutinized drugs required changes such as new warnings of possible side effects, according to a study. As part of the safety initiative, FDA’s Pediatric Advisory Committee reviewed 67 medicines over four years and recommended actions for 23, including Roche Holding AG's Tamiflu and Johnson & Johnson's Ditropan and Duragesic patches. Read the article
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Drug Name Confusion Common, Says USP
Posted: 4 September 2008
According to a new study from the US Pharmacopeia (USP), mixing up drugs with similar-sounding or similar-looking names is among the most common, and often deadly, medical mistakes. Nearly 1,500 commonly used drugs have names similar to at least one other medication, says the study by USP, an organization that helps set drug standards and promotes patient safety. In response, the group has created a Web-based tool to let consumers and doctors check whether they may be taking or prescribing any of these commonly mistaken drugs. Read the article
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Doctors Withholding Info on Expensive Treatments
Posted: 28 August 2008
A new survey shows that a quarter of UK doctors treating patients with myeloma, a form of bone marrow cancer, say they have withheld information about possible life-saving treatments from their patients because they are too expensive. When the National Institute for Health and Clinical Excellence (NICE) determines certain treatments are not cost effective, it essentially makes them unavailable to all but the wealthiest patients. The doctors who reported keeping their patients in the dark about expensive possible therapies say they believed it was better not to talk about unapproved treatments to avoid giving patients false hope. Read the article
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FDA to Station as Many as 15 Staffers in China by October
Posted: 28 August 2008
The US Food and Drug Administration (FDA) says up to 15 inspectors will be placed in three Chinese cities by October. FDA inspectors will be assigned to Beijing, Shanghai and Guangzhou and will be charged with conducting safety inspections of products exported for sale on the US market. The move has been in the works since December, when Chinese officials agreed to allow FDA to establish offices there. It comes largely in response to recent safety concerns over exported Chinese products, including the tainted blood thinner Heparin that has been linked to a number of US deaths. Read the article
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Device Maker Sues Federal Government Over Investigation
Posted: 28 August 2008
Stryker Corp., a Michigan-based medical device maker is suing two federal agencies, claiming they are abusing their power, unjustly harassing the company and damaging its business. Stryker filed the lawsuit in US District Court in New Jersey on 15 August, claiming subpoenas from the US Department of Justice and the US Department of Health and Human Services' Office of Inspector General are “oppressive and overbroad.” The agencies are investigating allegations that Stryker submitted false or improper claims for reimbursement under Medicare and Medicaid. The company settled with the US Attorney's Office in an earlier investigation into alleged kickbacks to surgeons. Read the article
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Stanford Sets Limits on Pharma Financing
Posted: 28 August 2008
Stanford University’s medical school has said it will set strict limits on drug companies’ financial support of doctors’ continuing education there. University leaders decided on the move due to concerns about the undue influence drug companies may have on doctors pursuing continuing medical education. While industry financing of these refresher courses has long been standard practice and drugmakers say their support is intended solely to keep doctors current, critics charge argue that it is primarily an effort to promote specific products. The University’s new policy will put drugmakers’ claims to the test. Companies may still provide financial support but will be asked to contribute only to a schoolwide pool of money that can be used for any class. Read the article
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Medco, FDA Team Up to Study Genetics’ Effects on Drugs
Posted: 21 August 2008
Medco Health Solutions, a prescription drug benefits management company, and the US Food and Drug Administration (FDA) are partnering to further research the role of genetics on drug safety and effectiveness. The move is intended to advance the development of what has been termed “personalized medicine,” medical treatments tailored to individuals based upon the patient’s unique genetic makeup. Over the next two years, Medco will deliver a series of reports to FDA on pharmacogenomics, the science of using a patient's genetic information to help predict likely reactions to various drugs. Read the article
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Court Rules PTC Must Allow Access to Experimental Drug
Posted: 21 August 2008
A federal judge ruled yesterday that PTC Therapeutics must provide its experimental drug, PTC124, to a Minnesota boy with Duchenne muscular dystrophy despite the company’s decision the boy could not participate in the drug’s clinical trial. The family of 16-year-old Jacob Gunvalson says that PTC employees––including a senior vice president who hosted the family in her home––led them to believe he could participate in a clinical trial of PTC124, which may offer hope as a treatment of the rare, fatal disease. PTC lawyers argued that the company made no such promises and says that allowing individual exceptions during clinical trials is counterproductive to the development of new drugs as it would provide a disincentive for patients to participate in the actual trial. The company plans to appeal the court’s ruling. Read the article
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Journal Editors Oppose Preemption
Posted: 21 August 2008
Current and former editors of the New England Journal of Medicine have filed amicus curiae briefs in a Supreme Court case over whether approval of a medicine by the US Food and Drug Administration (FDA) preempts claims brought against the manufacturer in state courts. The briefs were filed in support of Diana Levine, a Vermont musician who lost her right arm to gangrene after receiving an injection of the anti-nausea drug promethazine. Levine sued the drugmaker, Wyeth, for failing to provide adequate warning and won a $6.8 million judgment in a Vermont Court. Levine has also received support in briefs from 47 states' attorneys general, several state medical associations and two former FDA commissioners. Wyeth argues that FDA approval preempts state tort claims. The Supreme Court is scheduled to hear the case this fall. The Court ruled earlier this year that FDA approval of medical devices does, in fact, preempt claims at the state level. Read the article
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NICE Chief Says Drugmakers Inflate Prices
Posted: 21 August 2008
The head of the UK’s National Institute for Health and Clinical Excellence (NICE) this week accused pharmaceutical companies of overpricing medicines to generate increased profits. In a very candid interview, NICE Chairman Sir Michael Rawlins called for an end to the “perverse incentives”—such as linking executives’ pay to companies’ stock prices—that conspire to drive up drug prices. NICE is an independent organization devoted to evaluating medications’ cost effectiveness. The Association of the British Pharmaceutical Industry responded to Rawlins’ comments by criticizing NICE and pointing out that pharmaceutical companies must earn a reasonable return on the huge amounts of money and time spent developing new medicines to attract and keep the investors that enable drugmakers to continue to develop new drugs and make them available to patients who need them. Read the article
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FDA Considers Narcotics Education for Docs
Posted: 21 August 2008
The US Food and Drug Administration (FDA) may recommend that doctors get special training on prescribing powerful painkillers such as methadone, fentanyl and oxycodone. State medical boards are responsible for doctors’ licensing requirements, including continuing education requirements, so FDA does not have the authority to mandate such training. But according to the agency’s director of the Division of Anesthesia, Analgesia and Rheumatology, Dr. Bob Rappaport, special training is a good idea and could help prevent deaths resulting from misprescribing or patient error. Rappaport says FDA probably will require narcotics manufacturers to monitor how their products are prescribed. Read the article
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FDA Official Calls for Transparency on Unapproved Drugs
Posted: 14 August 2008
While the US Food and Drug Administration’s (FDA) communications on unapproved drugs must legally be kept confidential, some, including John Jenkins, the director of FDA’s Office of New Drugs, would like to see greater transparency, according to an article on Forbes.com. As it stands, the only information available about why a given drug was rejected by FDA is what the drug’s sponsor chooses to make public, and the public’s only insight into the approval process itself comes from FDA’s advisory panel meetings. This often leaves concerned physicians and patients as well as investors and the general public with limited information. In some cases, FDA may reject a drug despite an advisory panel’s positive recommendation, raising even more questions and making the lack of any explanation more apparent. At times, the seeming discrepancy has resulted in protests by angry patients and investors. Meanwhile, FDA is legally unable to publicly explain its own decision. Read the article
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After Collapse of Price-Fixing Case, Companies Face Further Action
Posted: 14 August 2008
In the wake of a failed criminal prosecution against several drug companies for a price-fixing scheme worth at least £60 million, the UK’s National Health Service (NHS) is apparently forging ahead with new legal action. Despite what legal experts say was extensive evidence, the prosecution was thrown out of court last month because the judge ruled that price fixing was not a crime at the time the scheme allegedly took place. Lawyers for NHS are pressing ahead with a damages action and the Office of Fair Trading may also get involved. Read the article
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Prices Way Up for Some Drugs
Posted: 14 August 2008
Prices for a handful of prescription drugs are up by 100% or more, helping to drive up costs for insurers, patients and government programs, according to a study out of the University of Minnesota. The number of brand-name drugs increasing by 100% or more in price could double this year, compared with four years ago. In 2004, prices for 15 drugs increased by at least 100%. In the first half of this year, 17 medications have been the subject of such price hikes. In some cases, price increases are over 1,000% and in one instance, the price of a medicine is up over 3,000%––from under $17 to just shy of $600. Many of the drugs cited in the study are older products that treat rare, but often serious conditions. Read the article
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Lawsuit Rule Could be a Problem for Drugmakers
Posted: 14 August 2008
A proposal by the Financial Accounting Standards Board to require drugmakers to estimate the potential damages from all lawsuits has raised objections from six major pharmaceutical companies. Under the current rule, companies are only required to disclose estimated costs from a lawsuit when they believe they are likely to lose the case. This proposal would force them to estimate maximum possible losses from ongoing litigation, which the drugmakers say is an unreasonable burden. The six companies point out that they have collectively “defended hundreds of thousands of product liability claims” in the past 10 years. Read the article
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Bill Would Create Institute to Compare Medical Treatments
Posted: 7 August 2008
A bill was introduced in the US Senate this week that would establish a new national center to compare the effectiveness of drugs, medical devices and medical procedures. The Health Care Comparative Effectiveness Research Institute would help the Medicare system save money by identifying the most effective medical treatments and improve overall medical care. The institute, a non-profit, public/private collaboration, would disseminate research findings about head-to-head comparisons of medical options. Private research firms or existing public agencies would conduct the actual research, at least initially. Read the article
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New Guidelines for FDA Advisory Committees
Posted: 7 August 2008
Rep. John Dingell (D-MI) and Sen. Chuck Grassley (R-IA) are leading the call to overhaul the Food and Drug Administration, giving the agency more power over, and independence from, the industries it regulates. Proposed new FDA powers include the ability to levy fines, order drug recalls and roll out tougher restrictions on direct-to-consumer drug advertising. The push for a tougher, more effective FDA comes after a string of high-profile failures including deaths linked to tainted blood thinners and controversies over suppressed reports on the effectiveness of a cholesterol medication. While it is unlikely that a major FDA shake-up would happen before the November election, the lawmakers would like the next president to appoint a more independent commissioner. FDA officials "are too cozy with the companies they regulate," says Grassley. Read the article
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Some Say FDA Safety Tools Will Lead to More Approvals
Posted: 7 August 2008
The US Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program, which gives the agency authority to compel drugmakers to conduct further safety evaluations when a new drug becomes available, may actually lead to more drug approvals. According to one analysis, REMS is being used as a way to revive new drug applications that once seemed dead. The agency has applied REMS three times this year. At least one more such use of the new tool is in the works and there is speculation it may be applied to other products. Read the article
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Biotech Companies Dealt Patent Ruling Setback in UK
Posted: 7 August 2008
Last week, UK’s High Court dealt a severe setback to biotechnology companies that have staked claims to parts of the human genetic sequence. The court’s ruling may set a more demanding standard for intellectual property protection where bioinformatics are concerned. The case was the first in the UK to address how bioinformatics—the use of powerful computer programs to work out the relationship between the human genome and the design of new drugs—affects patentability. In its decision, the court revoked Human Genome Sciences’ patent on a disease-linked protein called “neutrokine-alpha.” Read the article
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Grassley, Dingell Call for Big Changes at FDA
Posted: 31 July 2008
Rep. John Dingell (D-MI) and Sen. Chuck Grassley (R-IA) are leading the call to overhaul the Food and Drug Administration, giving the agency more power over, and independence from, the industries it regulates. Proposed new FDA powers include the ability to levy fines, order drug recalls and roll out tougher restrictions on direct-to-consumer drug advertising. The push for a tougher, more effective FDA comes after a string of high-profile failures including deaths linked to tainted blood thinners and controversies over suppressed reports on the effectiveness of a cholesterol medication. While it is unlikely that a major FDA shake-up would happen before the November election, the lawmakers would like the next president to appoint a more independent commissioner. FDA officials "are too cozy with the companies they regulate," says Grassley. Read the article
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Registry Would Spare US Patients From Flawed Products
Posted: 31 July 2008
American doctors and others in the healthcare field are calling for a national joint registry, a database to track patients who receive artificial hips and knees and monitor any problems that may arise. While several countries, including Australia, the UK, Norway and Sweden, have such databases, the US does not. Experts say the risk that a US patient will get a faulty product and need a replacement procedure is double that of patients in countries with databases. Joint registries in countries like Sweden have led to the recall of flawed devices long before they have been pulled off the market in the US. Read the article
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Deadly Medication Errors at Home Increase
Posted: 31 July 2008
Deaths resulting from mistakes made by patients taking prescription drugs at home have risen dramatically over the past two decades, according to an analysis of US death certificates. The report examined nearly 50 million death certificates and found that more than 224,000 involved fatal medication errors, including overdoses and mixing prescription drugs with alcohol or illegal drugs. Deaths from medication mistakes at home increased by more than 700% between 1983 and 2004. The report’s authors blame the rise in home use of prescription painkillers and decreased medical supervision outside hospitals. Read the article
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Patients Drive Drug Development
Posted: 31 July 2008
A number of patients affected by rare or overlooked diseases are at the forefront of the recent trend of patient-supported research. Such patients, often frustrated by a lack of treatment options, have funneled personal wealth, technology savvy and entrepreneurial spirit into helping drive several new drug-discovery projects. Read the article
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Not Enough US Approved Medical Devices for Children
Posted: 24 July 2008
A dearth of medical devices approved for use in children in the US is forcing some pediatricians to use devices designed for adults or even to take young patients abroad for needed surgeries. Because the market for medical devices for children is relatively small compared with the market for adults, there is less profit incentive for companies to cater to young patients. The Food and Drug Administration Amendments Act passed last year provides some financial incentives to prompt companies to invest in making devices for children, but it also requires those companies to track patients at their own expense. Legal liability issues and the tricky ethical implications of conducting clinical trials on children also are obstacles. Read the article
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US and India Cooperate on Drug and Device Regulation
Posted: 24 July 2008
The Drug Controller General of India (DCGI), the Indian counterpart to the US Food and Drug Administration (FDA), is working with and learning from FDA to improve its capabilities in postmarket surveillance, regulation of medical devices and other areas.
Cooperation between the two agencies also is expected to touch on clinical practices and biological drugs and to strengthen DCGI’s capacity in chemicals-based drugs and in emerging areas where the Indian agency’s expertise is limited. At the same time, FDA is planning to open several offices in India, China and other locations throughout the world as part of its “FDA beyond our borders” initiative. Read the article
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Are Drugmakers a Good Investment in Current Market?
Posted: 24 July 2008
With healthcare costs rising for consumers and insurers, and many brand name drug patents expiring, the conventional wisdom of drug companies as safe havens in down markets is increasingly being challenged. Some of the most basic assumptions about the pharmaceutical industry’s stability are not holding up to scrutiny. Traditionally, drugmakers have been seen as more resistant to market fluctuations as patients would continue to take their medications even as pocketbooks were squeezed, but polls have shown that rising costs have now made patients more likely to skip doses, cut back on pills or just not fill prescriptions. During the second quarter of this year, the number of prescriptions dropped for the first time since the mid-1990s. At the same time, many of the biggest companies are facing patent expirations on medicines worth billions. And, while companies are trying to come up with replacements for these products, many cite a much more cautious approach by the US Food and Drug Administration as a major stumbling block. Read the article
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New PhRMA Marketing Code Means No More Free Pens
Posted: 17 July 2008
The Pharmaceutical Research and Manufacturers of America (PhRMA) released new voluntary guidelines last week calling for drugmakers to stop the use of free pens and other so-called “reminder” promotional items. PhRMA now says that such items may lead to misperceptions about pharmaceutical companies’ interactions with doctors and other healthcare providers, giving the impression that they “are not based on informing them about medical and scientific issues." The new code also calls for a ban on company-paid dinners for healthcare professionals. According to a 2007 report, drugmakers spend $30 billion a year on marketing, although the study did not specify what proportion is spent on the now prohibited items. Read the article
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FDA Changes Format of Nonapproval Letters
Posted: 17 July 2008
When the US Food and Drug Administration notifies companies whose pharmaceutical products are not approved for sale in the US, it will now use a more neutral format called a “complete response letter.” Beginning 11 August, the new format, intended partly to avoid alarming investors, will replace the “approvable” or “not approvable” letters used in the past, which some have complained do not provide a clear signal about a drug’s prospects for approval. The agency says the new letters will offer more details about what is missing from a drug application and, when possible, give advice on how to correct it.Read the article
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Side Effects May Reveal New Uses for Old Drugs
Posted: 17 July 2008
Mining the information about medicines’ side effects on drug warning labels could lead to new uses for existing medications, suggests a new study of drugs that provoke similar reactions. Researchers compared the side effects of 746 drugs looking for those with similar symptoms on the premise they might incidentally affect the same proteins. Biochemistry is complex and drugs typically have unintended side effects. Sometimes these unintended effects lead to new applications for a medicine. One such example is Viagra, which was originally developed to treat symptoms of coronary artery disease. By looking at the common side effects of different medicines, scientists hope to take a more purposeful approach to discovering such beneficial potential uses. Read the article
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Radio Tags May Interfere With Medical Devices
Posted: 17 July 2008
A new study suggests that radio frequency identification (RFID) tags may pose a danger when placed in close proximity to certain medical equipment. The report, appearing in The Journal of the American Medical Association, examined the effect RFID tags had on 41 different medical devices. In 123 tests, researchers said they were able to produce 34 incidents of electromagnetic interference, including 22 that were categorized as hazardous, affecting the proper functioning of critical care devices such as syringe pumps or external pacemakers. Read the article
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FDA Calls for More Testing for Diabetes Drugs
Posted: 10 July 2008
A US Food and Drug Administration (FDA) panel voted 14-2 last week to require all new diabetes drugs to undergo longer studies to test for increased risk of heart problems. Although FDA is not required to follow the panel's recommendation, it often does. The tougher safety standards could cost pharmaceutical manufacturers millions of dollars but experts on the panel say it would protect patients from unforeseen heart risks. FDA currently does not screen for heart risks associated with diabetes drugs. Read the article
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Diversification the Key to Drugmakers’ Future, Says Poll
Posted: 10 July 2008
Nearly a quarter of managers at the world’s top drug companies say that diversifying products offered and focusing more on emerging markets are the keys to sustaining future growth. This is according to a survey of managers from 30 of the world’s largest pharmaceutical companies. Respondents also voiced significant concerns about market access and reimbursement, cost-containment and R&D productivity issues. A representative from the German management consultancy that conducted the survey cited a shift away from selling only medications toward selling “health outcomes” and a growing effort to tap into the out-of-pocket sector. Read the article
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Lilly Launches DTC ED Campaign in UK, Fined in Australia
Posted: 10 July 2008
Eli Lilly has launched a direct-to-consumer ad campaign in the UK intended to dispel the myth that erectile dysfunction only affects older men. At the same time, the company has been fined in Australia for promoting its ED drug through a sex survey. Though the British campaign includes ads shown on British television, it is unbranded, no specific drug is mentioned and there is no direct pitch for any specific product. Thus, it does not qualify as advertising under European law. Meanwhile, in Australia, the company has been fined $60,000 for distributing a press release touting poll results on men's sex lives in an effort to promote its Cialis Once-A-Day erectile dysfunction drug. Read the article
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“Patent Pool” May Make Drugs Affordable for World’s Poor
Posted: 10 July 2008
An international organization created to buy medicine to fight AIDS, tuberculosis and malaria may create a “patent pool” that could help lower costs for drugs too expensive for people in developing nations. Unitaid has proposed creating a panel of experts to explore the feasibility of a “patent pool,” which would hold licenses on patented medicines and could have them made available at lower costs for poor countries. While patents have expired on most first-line AIDS medicines, for example, making generic versions cheap and available, patents still exist on many second-line and pediatric AIDS drugs. Initially, the panel would have five patent law experts who could negotiate with patent holders. Read the article
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FDA May Get $2.1 Billion for 2009
Posted: 3 July 2008
The House Agriculture Appropriations Subcommittee approved $2.1 billion for FDA in 2009, $282 million more than originally requested by the administration. The bill now goes to the House Appropriations Committee for mark-up before heading to the floor for consideration by the full House. Read the article
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OND and OSE to Work Together on Safety Issues
Posted: 3 July 2008
The Office of New Drugs (OND) and Office of Surveillance and Epidemiology (OSE) have signed a Memorandum of Agreement to collaborate on safety issues related to pending and approved drug products. In the past, OND was the primary office in dealing with safety questions, with OSE serving in a consulting role. According to a report in the IN VIVO Blog, CDER Director Janet Woodcock shepherded this agreement as part of the “Safety First” initiative. Read the article
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Whistle-Blower Cases Outpacing DoJ Resources
Posted: 3 July 2008
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is planning to take a close look at the regulations permitting the use of unlicensed medicines to meet the special needs of an individual patient. The current EU directive permits Member States such as the UK to develop provisions to allow an authorized healthcare professional to commission the manufacture of an unlicensed medicine to meet the special needs of an individual patient. However, the existing arrangements have been in effect for a considerable time and MHRA officials believe it is appropriate to review them in today’s healthcare context. The agency is holding informal consultations on the issue and also calling for stakeholders’ views on its proposals. Read the article
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Drugmakers Say Parallel Trade Affects Supply, Safety
Posted: 3 July 2008
The Food and Drug Administration’s (FDA) review process for medical devices has picked up speed since 2002, according to a new report from the agency. In fiscal 2006 FDA took an average of 335 days to approve medical devices, compared with 438 days in 2005, the report said. Device approvals under the agency's separate, abbreviated "510K" application process actually increased slightly from 2005 to 2006, but overall review time is still down since Congress passed a law overhauling device regulations in 2002. Approval data for fiscal 2007 is not yet available. Read the article
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FDA Has Strategically Cut Back on Meetings
Posted: 3 July 2008
The Food and Drug Administration’s heavier workload and focus on the FDA Amendments Act and the Safety First initiative have caused the agency to strategically cut back on meetings with drug sponsors, and the situation is not likely to improve soon. FDA has had to re-prioritize its drug review activities and Office of New Drugs Director John Jenkins said recently that the agency has had to make strategic decisions about which meeting requests they are able to grant, and acknowledged that the driving factor is the lack of qualified staff. And while FDA is on a recruiting drive, it takes two to four years to train new reviewers. Read the article
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Prospect of Chinese Generics Raises Concern
Posted: 26 June 2008
China, already the world's largest producer of active ingredients in generic and brand-name medicines, may begin to export generic drugs to the US market within the next few years. FDA has already given tentative approval to a Chinese pharmaceutical company to sell a generic version of an AIDS drug, but considering China's spotty safety record, including the recent scandal involving contaminated ingredients in the blood thinner heparin, the prospect of Chinese drug exports has raised concern. The sale of Chinese-produced generics also would provide increased competition with US and other manufacturers and is expected to further drive down generic drug prices. Read the article
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Drug Companies Step Up Lobbying in ‘07
Posted: 26 June 2008
The pharmaceutical industry greatly increased its spending on lobbying efforts in 2007 when Democrats took control of Congress, according to a new watchdog report. The report from the Center for Public Integrity says drug companies spent $168 million on lobbying last year, up 32% from the previous year. Also, for the first time, the pharmaceutical and health-products industry gave more money to Democrats than Republicans, a change from previous election cycle patterns. Read the article
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UK Regulators to Reexamine Use of Unlicensed Medicines
Posted: 26 June 2008
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is planning to take a close look at the regulations permitting the use of unlicensed medicines to meet the special needs of an individual patient. The current EU directive permits Member States such as the UK to develop provisions to allow an authorized healthcare professional to commission the manufacture of an unlicensed medicine to meet the special needs of an individual patient. However, the existing arrangements have been in effect for a considerable time and MHRA officials believe it is appropriate to review them in today’s healthcare context. The agency is holding informal consultations on the issue and also calling for stakeholders’ views on its proposals. Read the article
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Medical Device Reviews Faster, Says FDA
Posted: 26 June 2008
The Food and Drug Administration’s (FDA) review process for medical devices has picked up speed since 2002, according to a new report from the agency. In fiscal 2006 FDA took an average of 335 days to approve medical devices, compared with 438 days in 2005, the report said. Device approvals under the agency's separate, abbreviated "510K" application process actually increased slightly from 2005 to 2006, but overall review time is still down since Congress passed a law overhauling device regulations in 2002. Approval data for fiscal 2007 is not yet available. Read the article
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FDA-EMEA Collaboration Allows Dual Submission
Posted: 19 June 2008
For the first time, the Food and Drug Administration and the European Medicines Agency worked together to allow simultaneous submission of a single application to both agencies. Under a framework called the Voluntary Exploratory Data Submission review process, drug companies submitted the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to FDA and EMEA for consideration. Read the article
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Drug Makers Ranked Based on Access in Poor Nations
Posted: 19 June 2008
A Dutch group called the Access to Medicine Foundation has unveiled its new index ranking pharmaceutical companies based upon how easy they make it for people in developing nations to get medicines and vaccines. The index is intended for investors who want to get a sense of drug companies’ commitment to social responsibility in the developing world. Ranking criteria include: how cheaply companies sell their products in poor countries, which drugs or vaccines they ship to which countries, whether they permit sales of generic versions of their patented drugs, how much they donate and how much research they do into neglected diseases. Read the article
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Drug Companies Agree to Ad Restrictions
Posted: 19 June 2008
Under pressure from Congress, several major drug companies have agreed to a six-month waiting period before advertising new drugs to consumers. House Energy and Commerce Committee chairman John Dingell (D-MI) and Bart Stupak (D-MI), chairman of the committee’s oversight and investigations subcommittee had initially sought a two-year DTC advertising moratorium, as well as limits on the use of doctors in ads. The companies also agreed to follow American Medical Association guidelines on using actors to portray doctors. Read the article
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Effects of EU Chemical Restrictions Felt Globally
Posted: 19 June 2008
In the wake of Europe’s new restrictions on chemicals linked to health problems, companies that conduct business in the EU are being compelled to change how they produce a wide range of products. The new laws in the European Union, to be phased in over the next decade, require companies to demonstrate that a chemical used in a product is safe before the product can be made commercially available. This approach is the opposite of US policies, where the burden of proof is on regulators to show that a chemical is harmful. Manufacturers and the Bush administration oppose the EU restrictions, arguing they will force companies to spend billions to comply and may drive up prices. Read the article
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UK to Allow Patients to Supplement NHS Coverage
Posted: 19 June 2008
In response to public pressure, British officials are expected to announce that patients will no longer forfeit their free National Health Service treatment if they choose to use advanced new drugs not covered by NHS. Until now, the Department of Health has argued that allowing such co-payments would create a “two-tier” health system. Recent media reports have underscored the hardships of terminally-ill patients who have had to pay for their NHS care because they chose also to be treated with drugs that the National Institute for Health and Clinical Excellence (NICE) has decided are not sufficiently cost-effective to be provided under the NHS. Read the article
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Bush Administration Asks Congress for More FDA Funding
Posted: 12 June 2008
After FDA’s commissioner first refused to name a figure for how much additional funding the agency would need then later said in a letter it would take $275 million, the Bush Administration has now officially asked Congress for the money. In a press call earlier this week Health and Human Services Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach for the first time said directly that the agency needs more money than the president requested this year “to enhance the safety of food and medical products,” according to Leavitt. Read the article
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Consumers Are Source for Most Adverse Event Reports
Posted: 12 June 2008
Consumers, not doctors, are now the major source of adverse event reports to FDA. In 1998, consumers were responsible for about half as many adverse events reports as physicians, 23,691 compared with 48,314. However, in 2006, that trend reversed. That year saw 127,475 consumer reports versus 113,444 physician reports, according to FDA data posted last week on the agency’s website. By 2007, consumers had become the source for the overwhelming majority of reports, reporting 174,216 adverse events, 53,216 more than reported by physicians. The increase in consumer-reported adverse events is thought to indicate greater awareness of drug safety issues. Read the article
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EGA Criticizes EU Patent System
Posted: 12 June 2008
In a new report, the European Generic medicines Association (EGA) says that patent linkage is the major barrier to generics competition. Patent linkage is a process that denies market authorization, price or reimbursement status to generic drugs until all patents on the originator product have expired or are declared uninfringed, invalid or unenforceable. Since fewer new drugs are coming to market, companies holding original patents “may be tempted to unjustly prolong” the patent monopoly of their existing products by extending the basic patent with the help of follow-on patents to keep generic competition off the market, according to the report. “Patent linkage is inconsistent with European law and must not be allowed to become ensconced in practice,” says EGA Director General Greg Perry. Read the article
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Torti Could Be Next FDA Commissioner, says RPM
Posted: 12 June 2008
Some industry observers are speculating that FDA's Principal Deputy Commissioner and first Chief Scientist Frank Torti may be in line to succeed Andrew von Eschenbach as commissioner, according to The RPM Report. Conventional wisdom holds that von Eschenbach will be asked to leave FDA after the November presidential election, regardless of who wins White House and that Torti is likely to be asked to be the interim commissioner, and perhaps take over the post permanently, depending upon who is elected. Asked about rumors surrounding his tenure at the agency, he reportedly smiled and said, “I’m not in the habit of taking a job no one’s told me about yet.” Read the article
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Demand for FDA Expertise Saps Agency’s Staff
Posted: 5 June 2008
Former FDA staffers often take their considerable expertise to drug companies, consultancies and other firms in the healthcare product sector leaving a vacuum of experience that may have negative consequences for the agency. As companies recruit some of FDA's more senior people, they leave an increasingly leaner, less experienced and less confident staff at the agency that may be more hesitant to put new drugs on the market, some analysts say. FDA has renounced critics who say drug approvals have slowed, but the agency is clearly in need of additional staff and resources as it recently announced a hiring initiative to fill 1,300 positions and FDA’s chief has publicly asked Congress for $275 million in additional funding. Read the article
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Chinese Regulators Move Quickly Following Deaths
Posted: 5 June 2008
In a signal the Chinese government may be following through on promises of tighter scrutiny of the pharmaceutical industry, government regulators acted quickly after the deaths of six patients who received a blood-based drug. The episode began with the death of a patient who received human immunoglobulin at a hospital in the Jiangxi Province. Over the next week, five more patients treated with the same drug died. The hospital notified the State Food and Drug Administration last week and regulators took immediate action, working with the manufacturer and every hospital that had received tubes of the drug from a suspect batch. Read the article
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Media Co. Challenges Canada’s DTC Ad Ban
Posted: 5 June 2008
Canadian media giant CanWest Mediaworks is suing the Canadian government over its ban on direct-to-consumer advertising of prescription drugs, saying it violates free speech rights and puts the company at a competitive disadvantage. CanWest, Canada’s largest newspaper publisher and owner of more than 30 television stations, is arguing in the Ontario Superior Court that the DTC advertising ban, which is included in the Food and Drugs Act, breaches its freedom of expression under Canada’s Charter of Rights and Freedoms. The company also says the ban puts the company at a disadvantage compared to US newspapers and magazines sold on Canadian newsstands, since US competitors can sell advertising to pharmaceutical manufacturers, which CanWest properties are prohibited from doing. Read the article
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For Pregnant Women: Better Drug Info, Too Few Options
Posted: 5 June 2008
FDA last week proposed changes to prescription drug labeling requirements that would provide more information for pregnant and breast-feeding women. However, women who are pregnant still face limited drug options. FDA’s proposed new system would provide doctors, pharmacists and their pregnant and breast-feeding patients with more detailed information about health risks and replace the current system which has been criticized as confusing and incomplete. The new system would seem to be a welcome change, but pregnant women still face a “drug drought” as few medications are being developed for complications of pregnancy, including conditions that threaten the lives of mothers and children. Often, doctors can save their patients only by delivering babies early. Read the article
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A Look Inside a UK Primate Lab
Posted: 5 June 2008
The European Commission is currently reviewing Directive 86/609, which governs animal research across the EU. While animal rights activists such as British Union for the Abolition of Vivisection argue that animal testing should be banned, some researchers counter that the research done on animals is vital to advancing the quest for understanding of, and ultimately developing treatments and cures for, disorders affecting humans. One reporter from the British newspaper, The Guardian, was recently granted inside access to a controversial lab conducting experiments on non-human primates in an effort to gain insights into the brain malfunctions that cause psychiatric conditions such as schizophrenia, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD) and depression. Read the article
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A Tough Market for Follow-on Drugs
Posted: 29 May 2008
Facing a tougher market for follow-on drugs, some drug companies are lowering prices or playing up new dosing in efforts to overcome skepticism that these products are not much more effective than the older drugs set to lose patent protection. Drug companies have used follow-on drugs to try to offset some of the revenue lost when older, top-selling drugs lose patent protection and become exposed to generic knockoffs. The goal is to convince patients, doctors and drug plans to switch to the newer drug that carries a brand-name price and patent protection over a generic equivalent of the older drug. However, drug-benefit plans tend to push use of generics to lower costs and bolster profit margins. Read the article
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Focus on Safety Causing Approval Delays
Posted: 29 May 2008
A new focus on drug safety is delaying the approval of some medicines as FDA regulators impose requirements meant to minimize adverse side effects, said Director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock. FDA gained new powers in March to require distribution limits or other restrictions on the sale of new medicines. Woodcock told Reuters that the process is adding days or weeks to reviews of drugs that need the additional safety measures, but that she expects the delays to ease as the agency gains more experience. Read the article
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FDA and EMEA May Conduct Joint Inspections
Posted: 29 May 2008
The Transatlantic Economic Council has created a set of guidelines aimed at increasing cooperation between FDA and EMEA and reducing duplicative efforts. As regulatory agencies such as FDA and EMEA are being called upon to monitor an increasingly diverse global industry, the TEC guidelines are intended to help the big regulatory bodies to pool resources and increase efficiency. Specific recommendations including launching of a pilot plan for joint FDA and EMEA inspections of pharmaceutical manufacturing facilities in the US and EU, as well as joint inspections of active pharmaceutical ingredient facilities in countries outside the EU and US. Read the article
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China Yet to Agree to FDA Presence
Posted: 29 May 2008
Chinese bureaucracy is holding up US efforts to establish FDA offices in China, says HHS Secretary Michael Leavitt. FDA wants to establish foreign offices in three Chinese cities to more effectively monitor food and medicine destined for the US. Leavitt said Chinese health officials support the concept of an FDA presence, but the Ministry of Foreign Affairs has yet to give its formal approval. Safety issues involving the blood thinner heparin, food and other products imported from China have put pressure on FDA to boost its capacity to conduct foreign inspections. Read the article
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FDA Wants More Money, Could Get Subpoena Power
Posted: 22 May 2008
Last week, FDA Commissioner Andrew von Eschenbach wrote Congress asking for $275 million to improve safety initiatives. At the same time, Rep. Bart Stupak (D-MI) seems to want to give the FDA subpoena power. Von Eschenbach’s letter to Sen. Arlen Spector (R-PA) is very unusual since it represents a radical departure from President Bush’s spending plan, but an FDA spokesperson has said it was a simple response to a request for more detail about what resources the agency would need to ensure imported drugs, medical devices and food products are safe. Also last week, Rep. Stupak sent von Eschenbach a letter that appears to prod the Commissioner to push for subpoena power, something that Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research, admitted during a public hearing last month would be useful. Read the article
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Congress Reconsiders FDA Preemption of State Law
Posted: 22 May 2008
The Committee on Oversight and Government Reform is taking another look at FDA preemption of state liability laws and its effect on public safety. The Committee held a hearing this week on whether the agency’s drug and medical device regulations bar state liability claims. In his opening statement, Committee Chairman Henry Waxman (R-CA) pointed out that FDA approval does not necessarily guarantee safety and argued that the threat of liability itself is an incentive for safety. Randall Lutter, FDA Deputy Commissioner for Policy, expressed concerned that state liability lawsuits that challenge FDA’s decisions can have a negative effect on public health by limiting available treatment options and increasing confusion. Read the article
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EU Officials Expand Antitrust Investigation
Posted: 22 May 2008
European antitrust investigators want to know if pharmaceutical companies are trying to block generics manufacturers from bringing cheaper medicines to market quickly, and are expanding a major investigation. EU officials are concerned that possible efforts by drug companies to block competitors by extending patents may also be having a negative impact on the development of new medicines, which have been slow in coming to market in recent years. Investigators already have questioned about 100 companies this year, and are now turning their attention to medical organizations and government agencies that set the prices of prescription drugs in Europe. Read the article
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WHO to Discuss Drug Patents
Posted: 22 May 2008
This week, the World Health Organization (WHO) brings together representatives from around the world in an attempt to revise drug patent rules and make critical medicines more accessible to developing nations. The international organization has struggled to find a way to encourage the development of effective, affordable medical treatments for the parasites and tropical diseases that are common in the developing world but unlikely to be profitable for the pharmaceutical companies that make them. Meanwhile, the pharmaceutical industry may be rethinking its approach to developing markets because of expanding middle classes and changes in developed markets like the US. Read the article
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DTC Drug Advertising Called Misleading
Posted: 15 May 2008
Representatives of several major drug companies appeared before Congress last week to answer charges that recent direct-to-consumer drug ads have sought to mislead consumers. Part of the testimony presented at the hearing of the House Energy and Commerce Committee Oversight Subcommittee focused on a discontinued ad campaign for prescription cholesterol drug Vytorin, a joint venture of Merck and Schering Plough. Lawmakers questioned company executives about why they continued the ads despite results of a study showing Vytorin was no better than a lower cost generic. Although the study was completed in 2006, the companies only released the data in January, following pressure from Congress. At the same hearing, American Medical Association President-elect Nancy Nielsen criticized DTC ads and called for more effective FDA oversight. Read the article
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Analysts: FDA’s Woodcock Better for Drug Approvals
Posted: 15 May 2008
Analysts believe Janet Woodcock’s return to FDA’s Center for Drug Evaluation and Research has led to an improved climate for drug approvals. Woodcock maintains that FDA’s approval standards have not changed. However, she does say that she does get directly involved in the approval process for “a very small number” of NDAs, because she is technically qualified, and says “I call them the way I see them.” Read the article
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MHRA Encourages Better Side-Effects Reporting
Posted: 15 May 2008
In response to growing concern over lax reporting of drugs’ side effects, UK regulators have taken steps to make it easier for healthcare professionals and patients to inform authorities. The UK currently uses a “yellow card system,” wherein doctors, nurses, pharmacists and patients are encouraged to report problems to the Medicines and Healthcare products Regulatory Agency (MHRA), but according to some estimates, only a fraction of adverse effects are reported each year. MHRA has set up a new website to ease reporting of such side effects and now requires drug promotional information to explicitly and prominently solicit reports of adverse effects and provide the website information. Read the article
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EC Seeks Public Comment on Device Regulation
Posted: 15 May 2008
The European Commission is considering a revision of the legal framework regarding the safety and efficacy of medical devices and is seeking public comment. New and emerging technologies have posed challenges to current regulations and officials believe the system can be improved. The EC hopes to gather input on possible improvements to the current directives and collect data on the socioeconomic impact of potential changes. The Commission is asking for comments and information to be submitted by 2 July. Read the article
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Drug Makers Support New Fees for More Foreign Inspections
Posted: 8 May 2008
Amid escalating public concern about the safety of medicines manufactured abroad, US pharmaceutical industry groups say they may support new fees to pay for more foreign plant inspections. Representatives of three industry trade groups testified before Congress last week, saying they may back proposed new fees that would provide the Food and Drug Administration with the increased resources to allow it to dramatically ramp up inspection of foreign manufacturing facilities. However, the drug makers expressed concern about the amount of the proposed fees and asked for assurances that the inspections would focus on higher-risk foreign manufacturers and that the system would not delay availability of pharmaceuticals in the US. Read the article
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China Says US Drug Maker Uncooperative
Posted: 8 May 2008
Chinese regulators say that US pharmaceutical maker Baxter Healthcare Corporation has failed to cooperate with their investigation into impurities found in heparin manufactured in a Chinese plant. The contaminated blood thinner has been linked to more than 80 deaths in the US and has been found in other nations as well. China’s State Food and Drug Administration says Baxter did not provide all requested samples and information during a visit to its New Jersey plant last month. Baxter denies the charge. The Chinese regulatory agency has questioned the link between the US deaths and impurities said to have originated in China. Read the article
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Abuse-Resistant OxyContin Causes Concern at FDA
Posted: 8 May 2008
Purdue Pharma is seeking approval by the Food and Drug Administration for its new “abuse-resistant” form of the painkiller OxyContin, but an FDA panel has voiced serious concerns. One panel member cited the “poor scientific rigor” of the data presented and said it bordered on insulting. The new version of the addictive pain medicine is resistant to being crushed or dissolved, potentially making it significantly more difficult to tamper with and abuse. The panel is considering whether it has enough tamper-resistant features to merit being made available before long-term studies are done. FDA also is considering how the tamper-resistant features should be treated on the labeling for the new version amid concerns about providing a “roadmap” to defeat them. Read the article
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In-Body Monitoring Shows Promise, Says UK Report
Posted: 8 May 2008
Someday, wireless devices implanted in humans could alert emergency services to unfolding medical emergencies such as epileptic seizures or heart attacks. This is according to a newly-published report by UK telecoms and media regulator Ofcom. The “in-body monitoring” implants would use technology based on the Bluetooth wireless sensor used in cell phones. However, the implementation of such monitoring seems a long way in the future as there are important questions to be answered about the long-term effects of wireless radiation, and few people are likely to volunteer to have experimental wireless devices implanted. Read the article
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FDA to Hire More Than 1,300
Posted: 1 May 2008
The Food and Drug Administration announced this week that it will hire 1,300 new staffers by September. Among them, FDA will be hiring for more than 600 new jobs and filling more than 700 existing, open positions. The agency says its areas of need include regulatory positions as well as medical officers, consumer safety officers, chemists, biologists and mathematical statisticians. The agency has been under scrutiny recently for its failure to inspect a Chinese manufacturer that may have introduced a contaminant into the blood thinner, heparin, which was later linked to more than 80 US deaths. Proposed legislation would authorize increased foreign inspections. Last week, the director of FDA’s Center for Drug Evaluation and Research told a Senate committee that manufacturers must take more responsibility for drug safety. Read the article
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NICE May Offer New Service to Drug Makers
Posted: 1 May 2008
In the UK, the National Institute for Health and Clinical Excellence (NICE) is considering a new service to offer scientific advice on products in development ahead of Phase III trials. The service could help companies in their regulatory discussions with the Medicines and Healthcare products Regulatory Agency and the European Medicines Agency regarding new products. NICE recently completed a successful pilot of the service and the Institute’s director of health technology will present the business case service to the NICE Board in May. Read the article
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EU Urges More Cooperation Between Pharma and Academia
Posted: 1 May 2008
The European Commission wants EU countries to work more closely with academics to convert what they learn through research into action for the greater good. The Commission has adopted a recommendation detailing what Member States can do to encourage greater cooperation between public research organizations (PROs) and universities on the one hand, and pharmaceutical companies on the other. European universities and PROs lag behind their US counterparts in terms of the numbers of inventions, patent applications, licensing deals and spin-offs they produce, despite similar levels of scientific publications. Meanwhile, in a separate development, the Association of American Medical Colleges has called for a ban on gifts from drug and device makers. Read the article
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FDA Criticized, New Foreign Inspection Force Proposed
Posted: 24 April 2008
On Tuesday, members of a subcommittee of the House Energy and Commerce Committee pressed FDA Commissioner Andrew von Eschenbach for answers about the agency’s failure to inspect foreign drug manufacturers and what it would take to conduct foreign inspections. Late last week, several members of the committee introduced draft legislation entitled the “Food and Drug Administration Globalization Act of 2008,” to require greatly increased FDA inspections of foreign plants. The bill proposes creating a permanent foreign inspection force, with staff assigned to specific countries inspecting facilities regularly. According the Government Accountability Office, such a plan would cost an additional $70 million. Read the article
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Tainted Heparin Linked to More Deaths, Found in 11 Countries
Posted: 24 April 2008
Health insurance companies increasingly are moving to prescription drug pricing systems that shift much more of the cost of expensive drugs to the patients who need them. Traditionally, insurers have required patients to pay a set co-payment for their prescriptions, regardless of the price of the drug. But some companies are now charging patients a percentage — typically 20% to 33% — of expensive, so-called “Tier 4” drugs. The system started with Medicare but now has spread to a number of private insurers in response to employers looking to keep costs down. Critics argue that it places an undue financial burden on the sick and erodes the basic concept of insurance. Read the article
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Ghostwritten Articles Raise Questions for Off-Label Marketing
Posted: 24 April 2008
Last week’s report that Merck used ghostwriters to write medical journal articles in support of Vioxx did not help FDA’s case for letting drug makers use article reprints to promote drugs’ off-label uses. FDA has been considering a proposal to allow such promotion for unapproved uses of approved drugs as long as the articles distributed come from peer-reviewed medical journals. While the Vioxx case does not involve off-label promotion, it does call into question the integrity of journal articles. Read the article
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Canada May Ease Access to Emergency Contraceptives
Posted: 24 April 2008
A new proposal would allow Canadians to purchase the so-called morning-after pill without having to consult a pharmacist. Currently in Canada, consumers must talk with a pharmacist in order to obtain emergency contraceptives, allowing pharmacists to counsel individuals about using regular birth control and practicing safe sex. The proposal would allow the sale of Plan B contraceptives in front of the counter, but some pharmacists have raised concerns that many customers would miss out on valuable information. Others contend easier access would remove a barrier for those uncomfortable discussing personal matters and, ultimately, get the pill to more women who need it. Read the article
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Insurers to Help FDA Track Drug Safety
Posted: 17 April 2008
A few major health insurance companies will tap into their vast databases of medical claims and prescription drug-use data to help FDA identify problem drugs. Among the collaborators, WellPoint, Inc., the nation's largest insurer, announced its partnership with FDA to launch a groundbreaking real-time drug-surveillance system. The company will systematically scan its members’ medical data, looking for patterns that could indicate issues with certain drugs or combinations of drugs. FDA’s existing drug-safety monitoring system has experienced a number of recent high-profile failures and has come under increasing public scrutiny since the 2004 recall of Vioxx, a popular pain-killer that was on the market for more than five years and later linked to increased risk of heart attack. WellPoint went back to look at its Vioxx data and says it might have been able to flag problems with the drug within four months of its debut had the tracking system been in place then. The collaboration between FDA and insurers comes in response to a congressional mandate that the agency establish a more comprehensive computerized system for tracking problems. Read the article
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Insurance Companies Shift Burden of Expensive Drugs to Patients
Posted: 17 April 2008
Health insurance companies increasingly are moving to prescription drug pricing systems that shift much more of the cost of expensive drugs to the patients who need them. Traditionally, insurers have required patients to pay a set co-payment for their prescriptions, regardless of the price of the drug. But some companies are now charging patients a percentage — typically 20% to 33% — of expensive, so-called “Tier 4” drugs. The system started with Medicare but now has spread to a number of private insurers in response to employers looking to keep costs down. Critics argue that it places an undue financial burden on the sick and erodes the basic concept of insurance. Read the article
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Critics Raise Concerns Over Canada’s New Drug-Approval Plan
Posted: 17 April 2008
As Canada changes the way the nation’s drugs are approved and monitored, a number of health experts have raised safety concerns. The new plan calls for “progressive licensing,” which is intended to help make new drugs available more quickly, while requiring safety monitoring before and after they are introduced to the marketplace. However, critics of the plan charge that this approach will place more safety responsibilities on the drug companies and more emphasis on post-market surveillance, endangering Canadians. Read the article
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FDA Safety Plan Calls for Staff Increases
Posted: 10 April 2008
The Food and Drug Administration (FDA) has released a draft of its five-year drug safety plan, which includes hiring more staff focused on postmarket safety activities. The plan calls for more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors, as well as enhanced technological capabilities and communications. FDA will receive more than $29 million annually to devote to improving its drug-safety capabilities. Read the article
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Agreement to Bring Needed Vaccines to Developing World
Posted: 10 April 2008
A groundbreaking international agreement that would bring affordable vaccines to developing nations is close to approval. The agreement between the governments of Italy, the United Kingdom, Canada, Russia and Norway and the Bill and Melinda Gates Foundation would fund a $1.5 million program to spur development of new and affordable vaccines for the developing world. The six donors will support a pilot Advance Market Commitment to supply vaccines against pneumococcal disease, which kills 1.6 million people per year. The AMC is intended to provide incentives for pharmaceutical companies to create and distribute medicines and vaccines in countries lacking significant markets for such medicines. Read the article
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Drug Makers Hope to Use FDA Approval as Legal Shield
Posted: 10 April 2008
Though Johnson & Johnson obscured evidence that its Ortho Evra birth control patch potentially elevated the risk of blood clots and strokes, it is claiming that FDA approval of the drug means it cannot be sued. Essentially, the argument holds that FDA is the only agency with enough expertise to regulate pharmaceuticals and that its decisions should not be second-guessed by courts. In the case of Ortho Evra, documents disclosed as part of the lawsuits against Johnson & Johnson show that the company’s own researchers found that the patch delivered far more estrogen than low-dose pills, thereby increasing the risk of blood clots and strokes, but it significantly reduced the researchers’ numbers in public reports. A company spokesperson maintains that data were disclosed to FDA, the medical community and the public in a timely manner, but litigants claim the company took advantage of an overburdened FDA. Read the article
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US and Chinese Pharmacopoeias Expand Working Relationship
Posted: 10 April 2008
The pharmacopoeias of the US and China will work more closely together in future in a bid to improve the quality of medicines available in both countries. To that end, the US Pharmacopoeial Convention and the Chinese Pharmacopoeia Commission have signed a memorandum of understanding (MoU), to tighten the physical and documentary standards applied to pharmaceutical ingredients and establish processes to update existing monographs in both countries. Read the article
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Last-minute Drug Approvals Linked to Safety Issues
Posted: 3 April 2008
An analysis of drugs approved by FDA since 1993 shows a greater likelihood of safety issues among those that were approved shortly before the approval deadline. Nearly one-third of the 313 drugs that received FDA approval between 1993 and 2004 were approved within two months of the Prescription Drug User Fee Act (PDUFA) deadline. Among those, 14% were later discovered to have severe safety problems, compared to only a 2% rate of such problems for the other approved drugs. Read the article
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EMEA Publishes Q&A on Electronic Submissions
Posted: 3 April 2008
In January, EMEA announced plans to implement electronic-only submission of information in support of Marketing Authorization Applications by July 2008 and, ultimately, to require use of the Electronic Common Technical Document (eCTD). In order to address commonly-asked questions and provide technical guidance regarding the move to electronic submission, the agency now has released a new question-and-answer document. Read the article
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British Government Considers Publishing Prescription Data
Posted: 3 April 2008
The British government is considering making public the full details of 700 million prescriptions issued by general practitioners each year. Possible publication is intended to provide valuable information to help improve treatment, and hold doctors more accountable. However, critics say such a database could threaten patient confidentiality, undermine existing research databases and aid patients shopping for doctors more likely to prescribe certain medications. Read the article
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Health Canada Publishes Draft Biosimilar Guidance
Posted: 3 April 2008
As US lawmakers discuss legislation that would enable FDA to approve similar versions of biologic products, Health Canada has begun the process of creating a biosimilar regulatory framework. The agency recently posted draft guidance on its website containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway. Read the article
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International Group to Establish Stem-Cell Research Guidelines
Posted: 27 March 2008
An international group of scientists is working to establish guidelines for stem-cell therapies in response to the use of unproven treatments on sick patients. Members of the International Society for Stem Cell Research have expressed concern that patients and their families, desperate for hope, may devote time and money to treatments that have no scientific or clinical basis. Patients could suffer dangerous side effects from these treatments, which could also tarnish the field of legitimate stem-cell research. The Society will draft the new guidelines, which may be completed by year's end. Read the article
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Device Makers Increase Lobbying; Face Greater Federal Scrutiny
Posted: 27 March 2008
Big US medical device manufacturers are spending more than ever lobbying the federal government. As a group, medical supply companies spent more than $28 million on lobbying during 2007 — and not all records are in yet — surpassing the 2006 total of $26.5 million, according to US Senate records tabulated by the Washington, DC-based Center for Responsive Politics. In a separate story, federal investigators are now said to be targeting doctors suspected of taking kickbacks from orthopedic device manufacturers, following a long-running investigation. Read the article
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UK Scraps Drug Pricing, Drug Companies To Cut UK Investment
Posted: 27 March 2008
Pharmaceutical companies have lost confidence in investing in Britain following a government decision to scrap a 50-year-old drug pricing mechanism, according to a survey. Three-quarters of more than 100 drug makers with British operations said they had little confidence in the current UK market environment and 83% expect the position to deteriorate in the coming 12 months. More than a third of companies expect to cut investment in research and development in Britain. The head of the Association of the British Pharmaceutical Industry (APBI) says that the pricing scheme change likely will result in job cuts for the industry. Read the article
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McCain Supports Canadian Drug Imports
Posted: 27 March 2008
John McCain is bolstering his reputation as a maverick by encouraging Americans to buy lower- priced drugs from Canada, a plan that may cost the US drug industry $40 billion over 10 years. McCain, the presumptive Republican presidential nominee, says crossing the border for less-expensive drugs will increase healthcare access by lowering costs. Read the article
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FDA Plans China Presence; Some Call for Increased Funding
Posted: 20 March 2008
In the wake of a controversy over tainted drugs from a Chinese manufacturer, FDA announced that it plans to place regulators in China. While the percentage of pharmaceuticals, pharmaceutical ingredients and other products manufactured in China for the US market has increased sharply in recent years, FDA has been unable to keep pace with inspections of Chinese manufacturing facilities. In an effort to remedy this situation, the agency announced its plans to establish eight permanent, full-time positions in China. Some industry experts and Congressional leaders also are calling for increased funding for FDA, which is in line for just a 3% budget increase for next year. Read the article
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Industry Group Calls for Incentives for Orphan Devices in EU
Posted: 20 March 2008
The European Commission should offer incentives for research on medical devices for rare diseases similar to the ones it provides for orphan medicines, according to an industry group. Eucomed, which represents designers, manufacturers and suppliers of medical technology for the European market, made its recommendations in response to a European Commission public consultation on rare diseases. Current Directives allow some devices to be marketed without a full conformity assessment, but implementation is left to individual European Union member states, resulting in uneven access to diagnosis and treatment. An orphan regulation on devices and diagnostics also would help address the fragmented tracking of diagnoses of rare diseases, the group adds. Read the article
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Health Canada Creates Consumer Office
Posted: 20 March 2008
Health Canada has set up a new liaison office to resolve consumer complaints related to Canada’s Food and Drugs Act. According to a press release, The Food and Drugs Act Liaison Office (FDALO) will provide “independent and confidential” advice to consumers struggling with the regulatory process or with the policies and procedures used in the act. Read the article
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FDA may miss drug approval deadlines
Posted: 13 March 2008
Since the Prescription Drug User Fee program was created 15 years ago, FDA has been able to make decisions about the approvability of new drugs on a tight deadline. However, because of an unofficial and unpublicized directive, FDA could miss more than 10% of user fee deadlines this year. Read the article
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Drug firms may face stricter disclosure standards in Britain
Posted: 13 March 2008
The British government is seeking to compel drug companies to disclose the results of clinical trials earlier. The move comes in the wake of an investigation that found GlaxoSmithKline had withheld evidence liking an antidepressant to increased likelihood of suicide among teens. British officials say that the company should have informed the Medicines and Healthcare products Regulatory Authority (MHRA) earlier but will not prosecute because the existing law is insufficiently clear on this point. Critics have called for changes to the MHRA, which they say is not currently able to effectively police the pharmaceutical industry. Read the article
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Woodcock to officially take over CDER once again
Posted: 13 March 2008
The Food and Drug Administration officially appointed Janet Woodcock director of FDA’s Center for Drug Evaluation and Research. This will be Woodcock’s second stint as CDER director. She had been serving as acting director since September. She will take over the directorship at a challenging juncture, overseeing implementation of a major new law granting FDA new authority over drugs already on the market. In addition, FDA has been under increased scrutiny by Congress in the wake of several recent controversies. Read the article
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New DOJ guidelines to address conflicts of interest in settlement cases
Posted: 13 March 2008
The Justice Department announced new guidelines for selecting monitors to track companies that enter into deferred-prosecution agreements with the federal government. The new guidelines require candidates for the appointments to be selected by committee and approved by the deputy attorney general. Previously, federal prosecutors were allowed to make the selections themselves. The change is intended to prevent conflicts of interest. The announcement came amid questions about former Attorney General John Ashcroft’s no-bid contract, worth $28 million to $52 million, to monitor a settlement between the government and Zimmer Holdings, an Indiana medical supply company, which had been under investigation on allegations of paying kickbacks to doctors. Read the article
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GAO to Investigate FDA Review Process
Posted: 6 March 2008
At the request of Senator Charles Grassley (R-Iowa), the Government Accountability Office is investigating FDA’s use of surrogate endpoints as the basis of approving new drugs. This has arisen from studies suggesting that Avandia (GlaxoSmithKline) and Vytorin (Merck/Schering-Plough Pharmaceuticals), may not be as effective as previously believed in preventing heart attacks and lowering arterial plaque, notes a story in the The San Diego Union-Tribune.
Avandia, cleared because it helps control blood sugar, was touted as lowering the risk of heart attacks, but an analysis released last year showed the product could actually increase that risk. Vytorin combines Merck’s Zocor with Schering-Plough’s Zetia to lower cholesterol. However, in a press release in January of this year, the manufacturer noted that a recent study showed Vytorin was no more effective at limiting cholesterol plaque in the carotid arteries than Zocor alone.
“At issue now is whether FDA should approve drugs based on biological methods, like cholesterol and blood sugar, without evidence they improve more meaningful measures like survival,” according to theUnion-Tribune article. Read the article
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Supreme Court Ties on Pharmaceutical Pre-emption Case
Posted: 6 March 2008
The Supreme Court voted four-to-four on a case involving the diabetes drug Rezulin, allowing a lawsuit against the manufacturer to move forward, thus failing to resolve the issue of pre-emption for prescription drug products approved by FDA.
In Warner-Lambert Co. v. Kent, 27 plaintiffs from Michigan are suing the Warner-Lambert Company, now owned by Pfizer, for liver damage suffered while taking the drug. The company had argued that, “the reasoning of a seven-year-old Supreme Court precedent barred individual damage suites that are based on the claim that a drug manufacturer obtained FDA approval through fraud,” writes Linda Greenhouse inThe New York Times. The tie vote automatically affirms the lower court’s judgment in this case, but does not set a precedent for other cases.
In its next term, the court is expected to take up another case involving pre-emption for drug manufacturers, Wyeth v. Levine, which focuses on protections afforded manufacturers by FDA-approved labeling.
In February, a court ruling extended preemption to manufacturers of devices that entered the market under a PMA and meet all FDA specifications.
Chief Justice John G. Roberts Jr. excused himself from the Warner-Lambert case because he owns stock in parent company Pfizer. Read the article
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Impurities Found in Chinese-made Blood Thinner
Posted: 6 March 2008
The Food and Drug Administration has found an unnamed contaminant in some samples of the blood-thinning drug heparin, manufactured by Baxter International. Agency officials also said that as many as 19 deaths may be linked to the drug. An FDA report released last week first revealed problems at a Chinese plant manufacturing heparin for the U.S. market. The plant was supposed to have been inspected before exporting the drug to the U.S., but FDA officials say that they actually approved a different plant with a similar name. In a separate announcement, China’s State Food and Drug Administration called for importing nations to assume responsibility for the safety and legality of pharmaceutical ingredients manufactured in China. Read the article
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FDA to Increase Warnings, Advisories on Side Effects
Posted: 6 March 2008
FDA expects to issue an increasing number of public health advisories and “early communications” for consumers about marketed health products, according to an article in The Wall Street Journal.
In the post-Vioxx climate, the agency has moved away from issuing notifications only after specific problems are identified toward advising that a problem is suspected. The WSJ article quotes FDA Commissioner Andrew von Eschenbach as saying, “I feel strongly it’s important for us to communicate early, but in communicating early we are acting with a much smaller degree of certainty.” Von Eschenbach was addressing the first meeting of the new FDA Risk Communication Advisory Committee.
The article also cites comments by FDA Deputy Commissioner Janet Woodcock, Acting Director of the Center for Drug Evaluation and Research. Woodcock told reporters that expanded resources provided by the Food and Drug Administration Amendments Act of 2007 will enable the agency to focus more on postmarketing surveillance than in the past. She also noted that FDA is working to develop a public-private network that will allow the agency to obtain information from medical databases and is updating its own adverse-event reporting system. Read the article
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New regulations possible for FDA foreign inspections
Posted: 28 February 2008
The revelation that the Chinese factory manufacturing a primary ingredient in a recently recalled heparin product was never inspected by FDA may result in new regulations mandating regular inspection of foreign facilities, according to a recent article in The Wall Street Journal.
Baxter International Inc. recalled nine lots of its heparin sodium injection following 350 reported adverse reactions and four fatalities. Subsequent investigation found that the active ingredient supplier in Changzhou, China had never been inspected by FDA. This, according to an agency statement, was the result of “confusion over similar-sounding names” resulting in the company being mistaken for one previously inspected.
US Reps John Dingell and Bart Stupak, both of Michigan, have demanded an explanation from FDA and the Department of Health and Human Services. Dingell chairs the House Committee on Energy and Commerce; Stupak chairs the subcommittee on Oversight and Investigations. A letter from the Congressmen to FDA Commissioner Andrew C. von Eschenbach stated that FDA staff “advised that selling a drug product from a plant that has never undergone a preapproval inspection does not constitute the distribution of an unapproved drug.” Consequently, the lawmakers are considering legislation that would prohibit marketing a drug from a plant that has not been inspected by FDA. Read the article
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Supreme Court decision protects device manufacturers
Posted: 28 February 2008
A US Supreme Court decision on 20 February grants manufacturers immunity from personal liability lawsuits for medical devices subject to FDA’s premarket approval process and meeting all required specifications.
Premarket approval was established in the Medical Device Amendments of 1976. This decision applies only to devices approved via the PMA process, not those found by FDA to be “substantially equivalent” to existing devices. It also does not preclude lawsuits based upon claims that a device was improperly manufactured and, therefore, does not meet agency specifications.
This decision is considered a victory for the Bush administration, which, in 2004, “reversed longstanding federal policy and began arguing that ‘premarket approval’ of a new medical device by the FDA overrides most claims for damages under state law,” writes Linda Greenhouse in The New York Times.
The court was scheduled to hear a similar case involving a prescription drug product on Monday 25 February. Read the article
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UK scientists developing nanoparticle-based delivery system
Posted: 28 February 2008
A team of scientists at the UK’s University of Portsmouth is developing a nanoparticle-based delivery system with the potential to improve treatment of central nervous system diseases. According to an article on in-PharmaTechnologist.com, the scientists are utilizing natural “polymer-based nanoparticles to modify a naturally occurring peptide capable of creating temporary openings in the blood-brain barrier, allowing for improved drug delivery.”
Nanotechnology has been slow to deliver on many of its perceived benefits, but in the medical field is now being used to improve drug production and delivery techniques.
The three-year project in Portsmouth is being funded by the Biotechnology and Biological Sciences Research Council. Read the article
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EC ethical guideline on trials in children
Posted: 28 February 2008
The European Commission has published Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population. The guideline is based upon recommendations from the EC’s ad hoc group for developing implementing guidelines under the Clinical Trials Directive, 2001/20/EC.
Both the Clinical Trials Directive and the new Community Regulation on medicinal products for use in the paediatric population (No. 1901/2006) emphasize the need for more clinical trials data on medicinal products for children. Quoting an article on PharmaTimes.com, “the Commission’s ethical guideline addresses the sharp increase in the number of trials conducted in children that will result from the EU regulation’s various requirements and incentives for paediatric testing.” Read the article (free subscription required)
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Agency coalition may end animal testing
Posted: 21 February 2008
A coalition of three government agencies—The Environmental Protection Agency, the National Toxicology Program and the National Institutes of Health—has signed a Memorandum of Understanding that could end animal testing of new chemicals and drugs.
According to an article in the 14 February 2008 edition of USA Today, the program builds on work performed by EPA and the National Toxicology Program on toxicological testing that began in 2005. The testing system uses computer-driven equipment to expose human cells grown in test tubes to chemicals and analyze the results.
EPA is already using the system to evaluate 300 chemicals using the new methods.
Under the new agreement, testing will begin with compounds previously tested on animals to confirm the cell-based tests are accurate. Read the article
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FDA proposes guidelines for “off-label” drug use
Posted: 21 February 2008
FDA has proposed guidelines that would allow drug and device manufacturers to provide copies of medical journal articles discussing “off-label” uses of their products to doctors. These are alternative uses for products other than the indication for which a product was originally vetted or approved by FDA.
Under the proposed rule, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, companies will be allowed to distribute articles that are peer-reviewed and have been published in a journal with an expert editorial board. A prominent warning must accompany the article, making clear the use described is neither approved nor cleared by the agency.
According to a recent New York Times article, advocates of the proposal insist providing these articles to doctors is necessary because FDA is slow in assessing drugs and “companies need to be able to hand out medical journal articles so that doctors can learn immediately about potential life-saving uses.” On the other hand, critics point to a history of drug and device companies promoting unapproved uses that have later proven to be dangerous.
FDA will accept public comments on the proposal for 60 days before final consideration. Read the article (login required)
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Revisions to current EC legislation on primate testing expected
Posted: 21 February 2008
Significant revisions to current EU legislation (Directive 86/609/EC) on the use of non-human primates in laboratory experimentation are expected. However the European Commission appears unlikely to support an outright ban on the use of non-human primates in research, says a recent in-Pharmatechnologist article.
The changes being discussed are in response to a declaration issued in September 2007 by Animal Defenders International, a UK-based animal welfare group. The declaration, signed by an unprecedented 433 Members of the European Parliament, calls for establishment of a timetable to phase-out the use of non-human primates in animal testing.
Directive 86/609/EC outlines, “control measures for animal research across all European countries,” according to in-Pharmatechnologist. Some animal welfare groups believe the directive, which has been in effect for more than 20 years, fails to take into account advances in research.
The directive is now being debated by the European Parliament. Read the article
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Generics take larger market share
Posted: 21 February 2008
Generic drugmakers captured 65% of the US market in 2007, the largest share in history, up from 63% the preceding year. The figures were announced at the Generic Pharmaceutical Association’s annual meeting 12 February.
An article on Bloomberg.com notes, “generic drugmakers are capitalizing on expiring patents and efforts by insurers to rein in healthcare costs.”
Industry gains are expected to continue this year as patents expire on best-selling prescription drugs like Merck’s Fosamax and Johnson & Johnson’s Respirdal.
Higher-priced brand-name drugs account for approximately 80% of annual US prescription expenditures. Read the article
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Fake malaria drug trade exposed in Southeast Asia
Posted: 21 February 2008
Scientists assisted police in exposing a large counterfeit malaria drug trade operating in Southeast Asia, where investigators sampled malaria tablets in several countries and discovered that as many as half were counterfeits, according to a recent Reuters article.
The investigation, led by Interpol with input from international researchers, found that most of the counterfeits examined contained no active drugs, while “some had potentially toxic ingredients, including banned pharmaceuticals and even the raw material for making ecstasy.”
The scientists involved in the investigation told the Public Library of Science journal PLoS Medicine that by using pollen traces and chemical analysis they were able to trace the origin of the some of the fake malaria medicines to southern China, leading authorities there to arrest a suspect in the Yunnan Province in 2006.
According to the Reuters article, Dr. Paul Newton, the main author of the PLoS report, fears this case “may be just the tip of the iceberg.” Read the article
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Quality control investigated in Puerto Rico pharma industry
Posted: 14 February 2008
An Associated Press investigation into the Puerto Rico pharmaceutical industry has revealed several instances of lapses in quality control over the past four years, the most recent case discovering paint flecks on a batch of blood pressure medication, says a recent article in The Washington Post.
According to that article, a review of FDA reports from inspections of 13 pharmaceutical plants from 2003 to 2007 shows, “even modern drug plants here under the watch of US regulators have failed to keep laboratories sterile and have exported tainted pills.”
FDA, on the other hand, says the problems in Puerto Rico are no worse than on the US mainland and are in proportion to the large number of pharmaceutical plants there.
Of the 20 best-selling drugs in the US, 13 are manufactured in Puerto Rico. Pharmaceutical plants in Puerto Rico produce $35 billion in drugs each year, most sold as part of the $300 billion US market, says the Post article. Read the article
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Pharmaceutical industry to recoup patent losses with authorized generics
Posted: 14 February 2008
The pharmaceutical industry hopes to recoup expected losses to generic competition in 2008 by creating a relatively new category of drugs called authorized generics, says a recent article in Business Week.
According to that article, more than 10 top-selling drugs will lose their patent protection in 2008, allowing cheaper generic versions to enter the market. To combat sales losses to traditional generic firms, brand name manufacturers are expected to license exact copies of their original drugs to specified generic companies to ensure a share in revenues. This approach is expected to appeal “to those patients who feel most comfortable with a name they know.” Read the article
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FDA to reclassify regulatory status of device software
Posted: 14 February 2008
FDA recently published a proposed rule to reclassify the regulatory status for Medical Device Data System (MDDS) software, says a recent article at HealthDataManagement.com.
MDDS data systems, “transmit, exchange, store, or retrieve data in its original format or can be used to convert the medical device data from one format to another so that the arrangement or organization of the medical device data is in accordance with preset specifications.”
Currently, this software is a Class III medical device, FDA’s most expensive and stringent classification, which requires agency premarket approval. The proposed rule, published in the 8 February Federal Register, will reclassify the software as Class I, the least stringent classification. Read the article
For a full text of the proposed rule, visit gpoaccess.gov.
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Tattooing method shows promise for delivery of DNA vaccinations
Posted: 14 February 2008
DNA vaccines delivered through tattooing may induce better humoral and cellular responses than those administered by intramuscular injection, says a recent in-Pharmatechnologist article.
Researchers at Heidelberg’s German Cancer Research Centre (Krebsforschungszentrum) and the Institute of Haematology and Blood Transfusion in Prague, Czech Republic compared immunization protocols using different routes of administration and molecular adjuvants in a mouse model. Results indicated that DNA vaccination via tattoo, “seems to be the method of choice if faster and stronger immune responses have to be achieved,” said research lead Martin Müller.
According to in-Pharmatechnologist, “Although the researchers did not determine the mechanisms by which DNA tattooing in the mouse model induced a superior immune response to intramuscular delivery, they speculated that the effect might be due to: (a) better uptake of the DNA by non-antigen-presenting cells; (b) better uptake of the DNA by antigen-presenting cells; (c) the duration of expression; (d) the induced traumata accompanying the tattooing (i.e., causing sufficient inflammation to prime the immune system).” Read the article
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MHRA launches new medical device vigilance reporting guidance
Posted: 14 February 2008
The Medicines and Healthcare products Regulatory Agency (MHRA) has released the third edition of its Directives Bulletin No. 3, Guidance on the operation of the EU vigilance system in the UK. Available online, the new Directive Bulletin provides guidance on postmarketing surveillance and vigilance.
The Bulletin encourages manufacturers and their Authorised Representatives to utilize online reporting through MHRA’s Manufacturers’ Online Reporting Environment (MORE). Read the article
The new edition of the bulletin, has been launched as an operational draft with a three-month comment period. For more information regarding the bulletin, or and to download it as a PDF file, please visit:Directives Bulletin 3 - Guidance on the operation of the EU vigilance system in the UK
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EMEA to implement electronic-only submissions
Posted: 7 February 2008
The European Medicines Agency (EMEA) has announced a plan to implement electronic-only submissions for applications utilizing the Centralised Procedure as an interim step in the shift toward requiring the Electronic Common Technical Document (eCTD) format.
A recent EMEA news bulletin specified three major milestones in the agency’s move toward requiring eCTD submissions. First, on 1 July 2008, EMEA will accept electronic-only submissions, either in eCTD format or non-eCTD format. No additional paper copies will be required. Second, as of 1 January 2009, EMEA will strongly recommend electronic-only submissions. Paper submissions will be an exception to the general e-format recommended for any application. Finally, from 1 July 2009, eCTD-format electronic-only submissions will be strongly recommended. Paper and other electronic formats will be an exception to the general eCTD format.
For more information regarding this process, please visit the following address for a question-and-answer document regarding EMEA’s statement of intent: EMEA Implementation of Electronic Submission and eCTD Submissions: Statement of Intent
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Budget to boost FDA in biotech generics and user fees
Posted: 7 February 2008
US President George W. Bush’s recently proposed budget for Fiscal 2009 includes new fees to accelerate FDA’s review of generic pharmaceuticals and would give the agency new authority to approve “generic” versions of some biotech drugs, says a recent article in Reuters.
According to that article, the White House requested an FDA budget of $2.4 billion for Fiscal 2009, a 5.7% increase over the 2008 budget. However, according to some, like former associate FDA commissioner and current advisor to the Alliance for a Stronger FDA, Bill Hubbard, this increase will not cover the cost of inflation.
“It’s pretty disappointing, especially in light of the overall unanimity of concern over food safety and drug safety,” Hubbard is quoted in the Reuters article. It is expected, however, that a Democratic-controlled Congress likely will alter much of the Bush Administration’s plan, crafting its own version of the budget over the months to come. Read the article (alternate link: Budget boost suggested to help fix FDA troubles)
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Korea to increase support of its Pharma R&D
Posted: 7 February 2008
Korea is preparing to open its market to global competition by boosting investment in its pharmaceutical industry there to support research and development (R&D), according to a recent article inKorea.net.
“To strengthen the competitiveness of the country’s pharmaceutical industry for the ratification of the Korea-U.S. free trade agreement, Korea’s Ministry of Health and Welfare announced Sunday (Feb. 3) that it will help strengthen the potential of Korean pharmaceutical firms by providing 51 billion won to support the firms’ R&D,” says Korea.net.
According to the article, the Korean pharmaceutical industry is expected to concentrate more resources on developing new medicines. Toward this end, the ministry will invest 7.5 billion won per year for the next seven years, while investing another 3 billion won in developing medical supplies and biogeneric medicines over the next six years. Read the article
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Research drought’ may contribute to decline in drug approvals
Posted: 7 February 2008
Industry analysts attribute the recent decline in the number of new drugs receiving approval to both more cautious regulators and less innovation by drug makers, says a recent USA Today article. According to that article, “Industry analysts say US FDA is more cautious after drawing criticism in recent years for approving some drugs whose risks were found to outweigh their benefits after they went on the market.”
However, FDA spokesman Christopher DeFrancesco says in the article that FDA’s standards for approving drugs have not changed and that the ratio of approvals to submissions has remained steady, at approximately 80% from 1997 through 2005.
Some say this decline in approvals can be traced to what Ira Loss, of research firm Washington Analysis, calls the industry's "research drought," which has led to weaker applications and, consequently, fewer approvals. According to Loss, an explosion of drug discoveries started in the late 1980s. This explosion peaked in the mid-1990s, then "petered out." Read the article
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FDA requires suicide studies in clinical trials
Posted: 31 January 2008
US FDA is now requiring that drug makers include a comprehensive suicide assessment in their clinical trials when developing medication to treat a range of conditions, including obesity, urinary incontinence, epilepsy, smoking cessation and depression.
According to a recent New York Times article, the change in FDA policy stems from the agency’s inquiry into a discovery made four years ago that claimed antidepressants might cause children and teenagers to become suicidal. Following the discovery, the agency commissioned a Columbia University-based psychiatry research team to reanalyze the drugs’ clinical trials, which led to the new system of assessments.
FDA has recently sent letters to several drug makers requiring they use in their clinical trials a scale developed by the research team called the Columbia Suicide Severity Rating Scale. Several companies are already using a detailed suicide assessment in clinical trials being currently conducted.Read the article
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Many doctors won’t see sales reps
Posted: 31 January 2008
A recent survey finds that drug and device industry sales representatives’ access to physicians is declining, reports Medical Marketing and Media.
A recent study, based on a telephone survey of 180,000 doctors during the fourth quarter of 2007, discovered that 19% of US office-based physicians refuse to see sales reps, while another 22.7% require reps to set up appointments.
According to a statement by SK&A President Dave Escalante, “The old days of walking into an office and bumping into the doctor are waning.”
Meanwhile, according to the article, nearly 73% of physicians surveyed will take details from reps at any time of day or any day of the week. Read the article
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FDA proposal criticized by lawmakers
Posted: 31 January 2008
Several House and Senate Democratic leaders have taken issue with a US FDA proposal that seeks to limit when drug and device companies can add warnings to product labels, says an article in The Star-Ledger. According to that article, the lawmakers believe that a new standard will “result in fewer company-initiated warnings, more drawn-out agency reviews and a longer time lag in informing the public about potential drug or device dangers.”
Earlier this month, FDA announced the proposal was designed to "codify the agency's longstanding view on when a change to the labeling of an approved drug, biologic or medical device may be made in advance of the agency's review of such change," says The Star-Ledger.
In a letter to the agency, several lawmakers said that the rule is too restrictive and that it comes “at the expense of consumers and violates the mission of FDA.” The letter was signed by Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee; Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform; Sen. Edward Kennedy (D-Mass.), chairman of the Senate Health, Education, Labor and Pensions Committee; and Sen. Patrick Leahy (D-Vt.), chairman of the House Judiciary Committee, and others. Read the article
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FDA wants comments on foreign small business status
Posted: 31 January 2008
US FDA is requesting comments on its new information requirements for foreign companies seeking small business status. The new requirements are a part of the Medical Device User Fee Amendments of 2007.
According to FDA, “The amendments provide a new way for foreign firms to qualify as small businesses, which pay lower medical device user fees, by allowing them to submit a certification from their national taxing authorities. Previously, if a business could not provide a U.S. income tax return, it could not qualify as a small business and had to pay standard user fees.”
Electronic comments on the collection of information can be submitted to:www.fda.gov/dockets/ecomments or www.regulations.gov. Read the article
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EMEA recommends approval of Thalidomide for myeloma treatment
Posted: 31 January 2008
The European Medicines Agency (EMEA) has recommended approval of Thalidomide as a treatment for multiple myeloma, a cancer of the blood. Multiple myeloma is diagnosed in approximately 25,000 people in the European Union each year, reports CNN.
According to a recent article in CNNMoney, the EMEA committee's opinion will be sent to the European Commission, “which generally follows the recommendation and issues final marketing approval within two to three months.” Read the article
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FDA considers establishing a presence in India
Posted: 24 January 2008
Increasing apprehension over the quality of food and drugs being imported into the US has led FDA to consider establishing a presence in India. FDA Commissioner Andrew Von Eschenbach and US Health and Human Services (HHS) secretary Michael Leavitt have begun visiting India to assess the manufacturing practices of some of the facilities in that country, says a recent article at in-PharmaTechnologist.com.
According to that article, Leavitt has described the current import protection system as “inadequate.” During a recent visit to India, Leavitt stated that HHS would like to provide technical assistance to India’s developing regulatory agencies. “We are considering trying to establish an FDA presence/office in India,” Leavitt said, although no decision has yet been made. Read the article
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EC views parallel trade as a “considerable risk” to patient safety
Posted: 24 January 2008
The European Commission is expected to launch a legislative initiative on the issue of counterfeit drugs in parallel trade after Parliament’s summer break, says a recent article in Pharma Times. The objective is to both prioritize and speed up moves to deal with the issue of counterfeit drugs in parallel trade, based upon findings from a Commission study on pharmaceutical distribution channels that began in December 2006. The first part of the study, dealing with safe medicines in parallel trade, was completed in late 2007. A report on the study published last November by the European Alliance for Access to Safe Medicines, revealed that counterfeit and substandard medicines are entering the EU market. A second study, covering counterfeit medicines, was to have been conducted in 2008.
According to Pharma Times, Commission Vice President Guenter Verheugen told Parliament last week that study results, “show that parallel trade brings a considerable risk for the safety of the patients. The reasons for that are numerous—there are problems with the packaging and labeling of the products as well as with product recalls, the complexity of distribution channels and the supply. And finally it is difficult to effectively enforce the law.”
Verheugen further told Parliament that the Commission is now analyzing these findings, “in order to develop a coherent strategy to avoid these risks.” Read the article
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US Supreme Court to consider shield for drug makers
Posted: 24 January 2008
The US Supreme Court will hear appeals from pharmaceutical industry lawyers who contend that federally approved warning labels should shield the industry from lawsuits in state courts from consumers who claim to have been hurt by prescribed medications, says the Los Angeles Times.
According to industry lawyers, drug companies should be protected from suits if their products have been approved by a federal agency—such as FDA—and if a warning label is included on the product. Most prescription drugs already come with labels indicating safe conditions for use and warning against overdosing or using the drug for purposes other than the prescription’s intended use.
Supreme Court justices recently voted to hear a pair of appeals from industry lawyers. If these appeals are upheld it would create a new barrier to consumer lawsuits, says the Los Angeles Times. “Congress has refused to erect a shield in the law. The high court could do so, however, in the cases to be hear later this year.” Read the article
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“Drug-free” stent coating shows potential
Posted: 24 January 2008
A new type of special polymer coated stent is demonstrating great success overcoming the major problems that resulted from an earlier generation of stents—little tubes that are inserted into arteries to keep them open after clot-clearing angioplasty. The new type of stent is not coated with drugs, but rather with a polymer that is designed to prevent thrombosis and restnosis, formation of new clots and build up of deposits that re-clog the blood vessels, according to a recent article in Health Day.
According to that article, a trial was performed at the University of Catania, in which the polymer coated stents were inserted in 55 people who underwent angioplasty. According Dr. Corrado Tamburino, professor of cardiology at the university, after six month there were no cases of thrombosis, death, or myocardial infarctions.
“The results were especially remarkable,” reports Health Day, “because one-third of the stent recipients were diabetic and thus more vulnerable to problems.” According to Tamburino, future trials will have to match results of angioplasty using existing drug-coated stents with the new polymer-coated stents. Each trial will take about six months to complete and, according to Tamburino, it could take years to produce definitive information. Read the article
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Federal panel concerned over growth of genetic tests
Posted: 24 January 2008
A federal advisory panel has released a report expressing concern that the increasing consumer demand for genetic tests might be outpacing regulation and oversight, reports a recent article in The New York Times. According to that article, millions of people have already begun taking the tests, with the hope of gaining information to help prevent, detect and treat hundreds of condition ranging from cancer, heart disease and diabetes to various blood disorders.
“With use of the tests growing at an explosive rate,” says New York Times, “the panel concluded that patients could be harmed. In most cases, the tests do not pose a direct physical risk; but, the panel said, if a test is inaccurate, patients may be given risky, unnecessary treatments or denied treatments that would be highly beneficial.”
While the panel’s report did not focus on the general ethical and social concerns of genetic testing, it did note that companies marketing tests directly to consumers, thus bypassing doctors, is a trend that raises “significant ethical concerns.” One such concern is that a growing number of the tests are being marketed with claims that the panel believes are unproven, ambiguous, false or potentially misleading. Read the article
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FDA: DTC user fee program will not commence
Posted: 17 January 2008
US FDA is expected to publish today a notice in the Federal Register stating that the DTC (direct-to-consumer) television advertisement user fee program will not commence because the necessary user fees for the program were not "provided in advance in appropriations acts" as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and that the previously issued notice establishing user fee rates for the program for fiscal year 2008 is being withdrawn.
See http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0390-n000002.pdf.
Via fiscal year 2008 omnibus appropriations legislation signed 26 December 2007, Congress has increased the amount of federal money available to fund FDA review of DTC television ads rather than appropriating the user fees negotiated by FDA and industry. The action apparently reflects House members’ concerns that user fees give the impression that drug makers are buying FDA approval. Accordingly, FDA does not now have the authority to collect DTC television ad user fees, and invoices to those companies expressing their intent to participate in the program will not be sent. FDA has stated that advertisements voluntarily submitted for review will be "reviewed in as timely a manner as resources permit."
The Consolidated Appropriations Act increases the funds available for FDA ad review by $4 million to $6.5 million. These funds are only available for fiscal year 2008, however, so Congress will have to address the issue again next year when it considers fiscal year 2009 appropriations.
This article was written by Stacy L. Ehrlich. Ehrlich is a partner in the Washington, DC, law firm of Kleinfeld, Kaplan and Becker LLP and can be reached at sehrlich@kkblaw.com. Ehrlich authored “The New Prescription Drug Television Advertsiement Advisory Review Fees” in the December 2007 issue of Regulatory Affairs Focus.
Federal Register homepage
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EU, Canada agree to share confidential regulatory info
Posted: 17 January 2008
Regulatory experts from Canada and the European Union agreed in December at a bilateral meeting in Brussels to share confidential information about authorization and medicine safety issues. The European Commission, the European Medicines Agency (EMEA) and the Health Products and Food Branch of Health Canada will now be able to share confidential information as part of their regulatory and scientific processes, both before and after a medicine has been approved, according to a press release published by Medical News Today.
According to the press release, “This closer cooperation between the authorities will provide earlier access to information and thus make it easier and quicker to take action to protect public health. Sharing information and expertise will help both the Canadian and EU authorities to further strengthen public health protection.”
The types of information covered in the agreement include: position papers on future legislation and/or regulatory guidance documents; scientific advice on product development given to companies to promote innovation; assessments of applications for marketing authorizations; and information about the safety of marketed medicines to better protect public health.
The benefits of the agreement, according to the press release, include accelerated access of patients to new and innovative medicines and improved performance and safety. Read the article
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Major drug makers hit record number of new drug tests
Posted: 17 January 2008
A record number of experimental drug tests are being carried out by big name pharmaceutical companies, says an article at Bloomberg.com. That article quotes states that about 1,425 potential therapies are in the industry’s research pipeline, 50% more than a decade ago. These potential treatments—for diabetes, cancer and brain disorders—may help prevent an anticipated 2011 revenue decline, when drugs generating $150 billion annually will face generic competition.
This influx of promising new treatments in the pipeline may also help increase investor confidence in the industry. According to Bloomberg, “Investors may be taking a wait-and-see approach after the US last year cleared the fewest number of drugs since 1983 and regulators delayed approval of medicines including Sanofi's weight-loss pill Zimulti.”
However, according to that article, “drug stocks are starting to rebound as investors buy companies less reliant on economic growth amid concern that the US economy will slow. The S&P drug maker index is up 4.7 % this week.” Read the article
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EC launches pharmaceutical antitrust inquiry
Posted: 17 January 2008
The European Commission has launched an inquiry into competition in the pharmaceuticals sector and is conducting inspections at the premises of a number of innovative and generic pharmaceutical companies. The inquiry is a response to indications that competition in pharmaceutical markets in Europe may not be working well: fewer new pharmaceuticals are being brought to market, and the entry of generic pharmaceuticals sometimes seems to be delayed.
According to a press release issued by the Commission, “the inquiry will examine whether agreements between pharmaceutical companies, such as settlements in patent disputes, may infringe the EC Treaty's prohibition on restrictive business practices. It will also look into whether companies may have created artificial barriers to entry, whether through the misuse of patent rights, vexatious litigation or other means, and whether such practices may infringe the EC Treaty's ban on abuses of dominant market positions… An interim report is planned for autumn 2008 and final results are expected in the spring of 2009.”
According to the press release, the kind of information investigations will examine the use of intellectual property rights, litigation and settlement agreements covering the EU. To carry out the inquiry, the Commission can use a wide range of investigative tools to gather information from companies and trade associations, including requests for information. The Commission uses the information obtained in the inquiry to better understand the market from the point of view of competition policy.
More information on the Commission’s previous sector inquiries is available at:
http://ec.europa.eu/comm/competition/antitrust/sector_inquiries.html
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FDA transitions to Federal Dockets Management System
Posted: 17 January 2008
US FDA will transition from the FDA Dockets Management System (DMS) to the Federal Dockets Management System (FDMS) over a three month period that began on 15 January 2008. According to information posted on the FDA website, all documents contained in the Division of Dockets Management (DDM) will be moved to FDMS using a phased migration approach. During the migration period, a Docket will remain in DMS for searching, viewing and downloading documents until it is migrated.
Migrated FDA Dockets with open comment periods became available in FDMS on 15 January. In addition, as of 15 January, electronic submissions are now accepted by FDA only through FDMS.
FDA will continue its phased migration through March 2008, until all Dockets open for comments, Dockets accepting late comments, and Closed Dockets are migrated. Read the article
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US Supreme Court declines experimental drugs case
posted: 17 January 2008
The Supreme Court refused earlier this week to review an earlier federal appeals court ruling that prevents terminally ill patients from being treated with experimental drugs. Last year, a federal appeals court, siding with US FDA, said the government may deny terminally ill patients access to drugs that have not been through extensive testing and have not received FDA approval—a process that can often take years.
However, according to a recent Associated Press article, “The court said patients can access experimental drugs in certain situations and suggested Congress could change the law to broaden such access.”
The Supreme Court reportedly did not explain its decision to leave the appeals court ruling undistributed. Chief Justice John Roberts did not take part in the action. Read the article
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FDA warns pharmacies on hormone claims
Posted: 17 January 2008
US FDA has begun to crack down on pharmacies that sell customized hormone mixtures as antidotes for menopause symptoms. Compounding pharmacies, meanwhile, claim the agency is going beyond its authority in attacking the use of the ingredient estriol, which FDA views as a new drug that has not yet won agency approval. FDA also says the hormone mixtures are being promoted with false claims about their benefits.
According to a recent article in The Wall Street Journal, the agency has sent letters to seven individual pharmacies warning them to stop using certain promotional language, and to stop selling hormone mixtures containing estriol. The special hormone combinations require a physician’s prescription. "We certainly hope other pharmacies will take heed," Deborah M. Autor, director of the FDA drug center's office of compliance, is quoted in The Wall Street Journal.
However, L.D. King, executive director of the International Academy of Compounding Pharmacists, says the majority of his member’s compounded hormone mixtures include estriol. “We are greatly troubled, to put it lightly,” L.D. King is quoted. King said the group will seek to meet with FDA officials. Read the article
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UK to cut drug prices
Posted: 11 January 2008
The UK government is planning to reduce the prices the National Health Service (NHS) pays for prescription drugs by 10% by mid-year. The plan is part of the Department of Health’s efforts to make savings of 3% a year, imposed by the Treasury’s comprehensive spending review unannounced last year.According to an article in Financial Times, “Government officials are believed to have staked out an initial position with industry to cut the £11bn annual medicines bill by at least 10%, or about £1bn.”
The pharmaceutical industry has expressed frustration at the demand and concern that the department is “interested only in the narrow issue of reducing medicine costs, without taking account of the savings drugs can provide in health and social care costs, and the damage that lower prices could do to investment in research and development in the UK,” reports Financial Times.
Drug makers previously agreed to an average 7% cut in medicine prices in 2005, which was supposed to run until 2010. Industry representatives say the five-year deal provides predictably and stability in pricing, encouraging investment in new drugs. Read the article
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Pakistan to support drug exports
Posted: 11 January 2008
Pakistan’s government is set to help the pharmaceutical industry enter the international export market by providing financial and technical support in the area of ‘bulk drugs’.
According to an article in Khaleej Times, Pakistan’s decision to penetrate the export market may be a result of the nation’s small domestic market, where “although the market of pharmaceutical industry is expanding at the rate of 20% annually, about half the population has so far no access to modern medicine.”
According to the Khaleej Times, Pakistan is rich in resources that can be used for the production of pharmaceutical raw material. Official planners recommend the major thrust of the export policy be on: pharmaceuticals and drugs, diagnosis pharmaceuticals, phyto-pharmaceutics, veterinary pharmaceutics and alternative medicines. Read the article
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India pharmacies stop sale of combination drugs
Posted: 11 January 2008
India’s retail pharmacies have decided to stop purchasing and selling combination drugs that are licensed by state drug regulators without proper quality safety tests, despite a Madras high court’s stay against the government’s decision to ban these controversial drugs, according to a recent article in Mint.
Although the Madras high court has secured a stay against the government’s ban, the country’s drug controller general has filed a counter-affidavit to justify the government’s decision to pull these brands from the market in the interest of patient safety. Meanwhile, the All India Organization of Chemists and Druggist (AIOCD) has decided to boycott the sale of more than 3000 drug brands, following the central regulator’s directive to withdraw licenses for all such drugs, reports Mint.
The AIOCD is India’s largest chemist and druggist association, representing more than two-thirds of the 580,000 drug wholesale and retail outlets in that country. Read the article
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Chinese project sequences genome
Posted: 11 January 2008
China’s Yanhuang Project, which plans to map the genomes of 100 Chinese people, recently sequenced the first volunteer’s genome. According to a recent article at Xinhuanet.com, up to this point only three individuals’ genomes have ever been sequenced, and all three of these were scientists.
"We hope that the rest of the 100 people will be volunteers who want to have their genomes sequenced for purely scientific purposes," Dr. Wang Jian, director of Beijing Genomics Institute’s Shenzhen branch, is quoted in the article.
The first volunteer donated 10 million Yuan [$1.3 million US] to the project along with his blood sample. The donor told Xinhuanet, “I believe more breakthroughs will be made in bio-tech and bio-pharmacy industries by sequencing and studying more Chinese genomes." Read the article
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New requirements for adverse event reporting established
Posted: 4 January 2008
Changes to the postmarket reporting requirements for drug products enacted by Chapter VII, SubChapter H, Section 760 of the Food, Drug, and Cosmetic Act establish new adverse event reporting requirements which apply to the manufacturers, packers, and distributors whose names appear on the labels of over-the-counter (OTC) or behind-the-counter (BTC) drugs marketed in the United States.
FDA uses Postmarketing Adverse Drug Experience (PADE) reports to identify domestic and foreign pharmaceutical firms for inspection. According to an FDA news release: “Drug application holders and certain manufacturers, packers, and distributors for prescription and non-prescription drugs are required to submit specific adverse event and drug safety information to FDA. These requirements are set forth in the Federal Food, Drug and Cosmetic Act and Title 21 of the Code of Federal Regulations.”
Final and draft guidances are available on FDA’s website, www.fda.gov/medwatch.otc.htm, which clarify the agency’s expectations for meeting regulatory requirements. Read the article
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Shanghai FDA withdrawals GMP certificates
Posted: 4 January 2008
The Shanghai government recently announced that Shanghai FDA withdrew two GMP certificates and suspended the production of two companies in an attempt to increase compliance to its new “five links” program.
The five links program was launched by Shanghai FDA in August, in an effort to enhance drug safety. Under this program, Shanghai FDA inspects drug makers in the following five areas: drug research and development, production, distribution, usage and advertising.
“There are 236 drug makers and 51 drug research organizations in Shanghai; the GMP certificates of 191 of 236 drug makers were past their expiration dates by the end of 2005, according to Du. As a result, all 191 drug makers were inspected in September, 178 of which will be continuously tracked and will be subject to further special inspections,” PharmAsia News reports.
Shanghai FDA Spokesman Du Bing told PharmAsia News that, “plans to further enhance drug safety through the five links for next year are under discussion,” and that Shanghai FDA will issue the plan either at the end of this month or early the next. Read the article
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FDA’s IT plan released for public comment
Posted: 4 January 2008
FDA’s Prescription Drug User Fee Act IV Information Technology Plan has recently been released for public comment. According to an article in Health Data Management, “The agency’s intent is to provide regulated industry and other stakeholders with information on its vision for improving the automation of business processes and maintaining IT systems that support the review of human drug applications.”
The Prescription Drug User Fee Act was reauthorized in September as part of the Food and Drug Administration Amendments Act of 2007. According to Health Data Management, the new law also includes four categories of IT goals for supporting the upgrading of FDA’s drug safety program: objectives, communications and technical interactions, standards and IT plan, and metrics and measures.
For a list of FDA’s IT goals and other performance goals in the new law, click here.
Certifications must be submitted to FDA beginning no later than 26 December 2007. Read the article
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Analysts foresee shift from developing blockbuster drugs
Posted: 4 January 2008
According to a recent Washington Post article, analysts are predicting that in today’s changing pharmaceuticals marketplace the drug industry will continue shifting development resources toward discovering treatments for niche markets, focusing more on patients with rare diseases or unusual strains of common afflictions, rather than on blockbuster drugs for more common ailments like arthritis or diabetes.
“There is no quick remedy for what ails the pharmaceutical industry: a tougher environment for drug approvals and a dwindling pipeline of new medications,” reports The Washington Post. “These twin challenges—evidence that the heyday of blockbuster drug-development is over—are forcing the industry to ponder big changes in the laboratory.”
The biggest of these changes, analyst say, will be to focus on boutique medications, which will help drug makers receive less scrutiny from increasingly tougher regulators, who have become “extra sensitive to the potentially fatal side effects of widely prescribed medication for ailments such as arthritis and diabetes.” The article also states that the growing market for niche treatments is “dictated by the reality of the business, in that there are fewer widespread maladies for which a popular pill doesn’t already exist.”Read the article