September
Drugmakers Argue Against Disclosure of Possibly Unrelated Adverse Events
Posted: 2 September 2010
Trade groups representing drugmakers and biotechnology companies have weighed in on a lawsuit involving disclosure of possibly unrelated adverse events. The suit on behalf of investors alleges that the maker of a popular cold medicine knowingly concealed some reports of the drug’s side effects. The drugmaker and trade groups argue that companies should not be compelled to disclose reports of adverse events that have not been scientifically proven to be related to the use of the medicine in question.
DDMAC Enforcement Letters Up; Most Cite Risk Info Problems
Posted: 2 September 2010
Warnings and notices issued by the US Food and Drug Administration’s (FDA) Division of Drug Marketing and Communications (DDMAC) for the first half of this year have increased significantly in comparison to recent years and data show that risk information is one of the most common problems cited. According to an analysis, inadequate risk information was identified most often, followed by overstated efficacy and superiority claims. Despite widespread industry concern over compliance issues for Internet-based promotions, only six of 108 violations involved a website.
FDA Launches Public Performance Tracking System
Posted: 2 September 2010
The US Food and Drug Administration (FDA) launched its public performance tracking system, FDA-Track, this week. The system will monitor more than 100 FDA program offices through data from key performance measures established each year, according to the agency. Data are expected to be updated quarterly. "FDA-TRACK will bring the operations of this historically opaque agency into the daylight and help us be even more responsive as we work to protect the public health," said FDA Commissioner Margaret Hamburg
Irish Medicines Board Limits Product Submission to One Month
Posted: 2 September 2010
The Irish Medicines Board (IRB), has announced it will only accept requests to act as the Reference Member State (RMS) in the EU’s Decentralised Procedure for marketing authorization approval during specific one-month periods. The move comes in response to the overwhelming number of requests the IRB has received to act as the RMS. The one-month window for submissions will be open at least once every year, according to the IRB. The window for product filings in the second to fourth quarter of 2011 opened 1 September and will close after the end of the month. The IRB may open additional submission widows depending on the regulator’s capacity to handle such requests.
August
Effect of Stem Cell Ruling Unclear, Appeal Planned
Posted: 26 August 2010
As the US Department of Justice plans its appeal of the ruling this week barring government funding of stem cell research, the actual effects of the ruling remain unclear. While National Institutes of Health (NIH) Director Francis Collins says he was “stunned” by the ruling and it “has the potential to do serious damage to one of the most promising areas of biomedical research, and just at the time when we were really gaining momentum." The ruling does not directly affect research conducted with private funding, but a number of proposals awaiting NIH review have now been put on hold and a lack of available government funding could have an overall chilling effect on research in the area. One Colorado lawmaker has announced plans to introduce new legislation to allow stem cell research to move forward.
More Pediatric Trials Conducted Outside US, Ethics Questioned
Posted: 26 August 2010
More pediatric trials are being conducted outside the US, often in poor countries, and the effects on the studied populations are being called into question. According to a new study, 65% of trials conducted under the US Food and Drug Administration’s (FDA) Pediatric Exclusivity Provision are conducted overseas, and 38% of trials included patients in a developing country. The provision, intended to spur development of pediatric medicines, grants drugmakers six months of patent extension in exchange for conducting safety and efficacy studies of their products for children. However, in some cases, patients my have little or no healthcare beyond the trial itself and the resulting drug may never be available or affordable to the studied population.
India Concerned About Drugmaker Mergers, Domestic Prices
Posted: 26 August 2010
Officials in India are concerned that consolidation among drugmakers could drive prices up for its citizens and is considering steps to ensure needed drugs remain available and affordable. India’s Department of Industrial Policy and Promotion has proposed strengthening compulsory licensing provisions, which would allow Indian drugmakers to make and sell patented medicines in an effort to keep prices for those medicines down and stabilize the supply in the event makers of the original drug raise prices sharply. If granted, the licenses would require royalties be paid to the patent holder.
German Pharmacists Say Drug Supply is Safe
Posted: 26 August 2010
In the wake of the revelation that counterfeit drugs had entered the legal supply chain through German pharmacies, ABDA, Germany’s pharmacy association, is taking steps to assure consumers that the supply of medicines in Germany is safe. "The safest way to get drugs in Germany is any one of the 21,500 community pharmacies," said an ABDA spokesman, who pointed out that there have been only 40 cases of counterfeiting in Germany's legal supply chain since 1996. ABDA also warns consumers to stay away from illegal or suspicious drug sources available on the Internet or elsewhere.
Big Drugmakers Pursue Biosimilars, Start-ups Work on ‘Bio-betters’
Posted: 19 August 2010
While a number of large drugmakers proceed with developing biosimilars, despite the lack of official guidance from the US Food and Drug Administration (FDA), some smaller companies are focusing on so-called “bio-betters.” US healthcare reform passed earlier this year created a regulatory pathway for biosimilars and some companies are rushing to be among the first to develop a biosimilar product for the US market. However, the lack of FDA guidance makes this a somewhat risky approach, and others are opting to proceed with the more established regulatory approval pathway for standalone biologic drugs. Bio-betters, which are biologics in the same class as an existing product, but which offer some distinct advantage, are viewed by some as the better opportunity and a number of smaller companies are currently developing such products.
Drug Recalls on the Rise
Posted: 19 August 2010
The US Food and Drug Administration (FDA) reported more than 1,700 drug recalls in 2009, a dramatic increase from fewer than 500 in 2008; however, an FDA official says the number of recall incidents has not risen. Recall incidents are recalls involving one product problem at a particular company. There were more recalls per incident in 2009 and more than 1,000 of the recalls were attributed to a single company, Advantage Dose, a drug repackager that has since gone out of business. Since so many recalls are being driven by relatively few companies, some say the characterization of the recall rise as a “surge” is a reach, but even if Advantage Dose is removed from the equation, there would still be a 50% increase in recalls, and this has raised concern among some industry observers.
Savings From Pay-for-delay Ban Overestimated, Says Report
Posted: 19 August 2010
A study funded by the trade group for generic drugmakers contends the Congressional Budget Office (CBO) analysis significantly overstated savings that would be realized from a ban on patent dispute settlements that keep generic medicines off the market longer. The Federal Trade Commission (FTC) has called for an end to such “pay-for-delay” deals in which brand-name drugmakers pay to delay the launch of generic competitors, and a CBO analysis provided support for the argument that the ban would save consumers and government money. The report charges the CBO and FTC used “faulty assumptions,” specifically, they were wrong to assume that banning these types of patent settlements would speed up generic entry into the marketplace by 17 months.
China, Germany Take Action Against Counterfeit Medicines
Posted: 19 August 2010
China's State Food and Drug Administration is working with provincial and national authorities to investigate and eradicate 33 counterfeit medicines currently in circulation. At the same time, German authorities are pursuing action against regional pharmacies suspected of purchasing and distributing cheap, illegal active ingredients used to manufacture in-house cancer treatments being sold to the general public. While China appears to be taking steps to improve its spotty reputation for pharmaceutical quality, the incident in Germany is relatively rare and has sparked concern about fakes entering the legal supply chain there.
Regulatory Pros More Involved in Business, Compensation Up
Posted: 12 August 2010
RAPS’ 2010 Scope of Practice & Compensation Report for the Regulatory Profession shows regulatory professionals are taking on a wider range of responsibilities, including business functions, and overall compensation continued on an upward trend, although it grew at a slightly slower pace. Also noteworthy among the findings is that RAC-certified professionals in the US reported compensation that is 6% higher than their non-RAC peers. The report was compiled from the results of a global survey of more than 3,000 regulatory professionals from 55 different countries.
FDA Cites Drugmaker for Facebook Promo
Posted: 12 August 2010
The US Food and Drug Administration (FDA) this week cited drugmaker Novartis for its use of a Facebook widget that the agency says failed to adhere to risk disclosure rules. The widget allows users to share links to sites they like with their Facebook friends. When the link is created, the widget adds a short description which in this case included efficacy claims for the drug Tasigna, but no risk information associated with the drug’s use. This is likely the first time FDA has issued such a warning in relation to a Facebook promotion.
EMA, FDA Seeking Participants for Pilot GMP Program
Posted: 12 August 2010
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have teamed up for a joint Good Manufacturing Practices (GMP) inspection pilot program. The agencies are seeking manufacturers of medicinal products to participate in the pilot to determine whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication of inspections.
US Senate Bill Would Create Incentives for Pediatric Drugs
Posted: 12 August 2010
Last week, a new bipartisan bill intended to spur research on drugs for rare and neglected pediatric diseases was introduced in the US Senate. The Creating Hope Act would amend existing law, offering drugmakers priority review for another drug within six months in exchange for developing such a pediatric medicine that might not otherwise receive sufficient research and development funding.
FDA Proposal Would Dramatically Change 510(k) Process
Posted: 5 August 2010
The US Food and Drug Administration (FDA) this week issued its proposed changes to the 510(k) approval process for medical devices. The long-awaited recommendations would dramatically change the review and approval process by creating a new class of devices, requiring additional information from sponsors and leveraging more expertise from outside FDA, among other things. The proposal attempts to address lingering questions about the 510(k) process and comes nearly a year after FDA’s Center for Devices and Radiological Health (CDRH) was sharply criticized amid controversy over safety recalls and internal division.
Drug Safety Bill Introduced in US Senate
Posted: 5 August 2010
A bill aimed at strengthening drug safety requirements that would grant the US Food and Drug Administration (FDA) additional authority was introduced in the US Senate this week. The bill would give FDA recall authority over drugs, rather than having the agency rely on voluntary manufacturer recalls. It also would give FDA subpoena powers, enhance the agency’s ability to track manufacturers outside the US that supply products for the US market and require more comprehensive documentation of drugmakers’ subcontractors.
India Increases Scrutiny of Clinical Trials, Biotech, Devices
Posted: 5 August 2010
The Drugs Controller General of India (DCGI), the country’s top health regulatory authority, has begun to enforce tougher approval standards for clinical trials and marketing licenses for biotechnology drugs, medical devices and vaccines in India. A number of vaccine marketing approval applications from large, big-name drugmakers were returned recently with deficiency letters attached, and sponsors have complained about long delays and sudden “bureaucratic” hurdles. A DCGI official has said the delays are the result of incomplete applications, and a senior health ministry official indicated that past approval standards for biotechnology products were not rigorous enough.
New Zealand Vows to Improve Drug Access
Posted: 5 August 2010
After ranking last among 14 nations in access to medicines, New Zealand officials have pledged improved access to drugs not funded through the country’s Pharmaceutical Schedule. New Zealand will review its three Exceptional Circumstances (EC) schemes overseen by Pharmac, the nation’s pharmaceutical management agency, with the goal of providing better access to medicines that are not funded through the Schedule, according to Health Minister Tony Ryall. Under the three EC schemes, Pharmac receives more than 3,000 applications each year from patients suffering from rare or difficult-to-treat conditions. "The Government is determined to see New Zealanders get better access to medicines, and I will be interested to see the feedback from consumers, as well as the health and pharmaceutical sectors," said Ryall.
July
FDA AdComm Rejects Opioid Class REMS
Posted: 29 July 2010
A US Food and Drug Administration (FDA) advisory committee has rejected the agency's proposed classwide opioid risk evaluation and mitigation strategy (REMS), saying the REMS did not do enough to prevent misuse and abuse. Committee members took issue with FDA's decision not to include mandatory physician training and patient registration as part of the REMS and to have the program apply only to extended-release opioids. FDA usually abides by the advice of its advisory committees.
More Suspect Medicines Seized in EU
Posted: 29 July 2010
Annual increases in seizures of medicines suspected of infringing intellectual property have led the EU to pay more attention to the problem. Medicines now total 10% of all articles seized, up from 2.1% in 2006. This growth has seen the number of medicine articles seized by EU customs officials increase from 2.7 million in 2006 to 11.5 million in 2009. The number of cases registered 2009 rose slightly over 2008, from 3,207 to 3,368.
US Senate Drops Pay-for-Delay Ban
Posted: 29 July 2010
The US Senate has thrown out a legislative proposal to ban the “pay-for-delay” agreements between brand-name and generic drugmakers that was recently approved by the US House of Representatives. The measure was part of the War Funding Bill, which also included billions of dollars to fund a range of unrelated domestic spending measures, one of which was the ban on payments between branded and generic drugmakers that aim to delay generic competition to patent-expired innovative drugs.
Increased Biotech Funding in Israel
Posted: 29 July 2010
The Israeli government has established a $250 (US) million biotechnology fund to rejuvenate the nation’s innovative drug development sector, but the local drugmaking sector is still in need of investment, says a recent report. Israel’s Teva Pharmaceutical Industries is the world’s largest generics maker and has also successfully developed and marketed its own patented medicines, but smaller, research-based ventures have had to use multinational firms as commercial partners due to their lack of marketing experience, according to the study, from Business Monitor International (BMI).
Critics of Biosimilar Pathway Call for Clinical Trials
Posted: 22 July 2010
Medical experts and critics of the biosimilar approval pathway created by the US healthcare reform law this week called for mandatory clinical trials for biosimilar drugs. They warned that allowing such medicines onto the marketplace without trials could lead to compromised safety and effectiveness, and said the law gives the US Food and Drug Administration (FDA) too much leeway to determine whether clinical trials are necessary. Rep. Anna Eshoo (D-CA), who sponsored the biosimilars provision, countered "The FDA has both the responsibility and the expertise to determine a drug’s safety and efficacy—not drug companies, insurance companies, or members of Congress. As technology evolves, the FDA must have the flexibility to determine the most effective ways to test biologics."
FDA Advisory Committee Members Support REMS
Posted: 22 July 2010
Members of advisory committees to the US Food and Drug Administration seem to have embraced REMS (Risk Evaluation and Mitigation Strategies) as an alternative to pulling certain drugs from the market or keeping them off the market in the first place. In instances such as the recent advisory committee hearing on controversial diabetes drug Avandia, a number of committee members have indicated that the strict postmarketing controls that can be part of REMS gives regulators the ability to allow a drug to be available to the patients who may benefit from it, while restricting its use by others and keeping track of safety issues.
Europe to Provide 6.4 Billion Euros for Research
Posted: 22 July 2010
The European Commission announced it will provide 6.4 billion euros in funding to boost science research and innovation. Health researchers will receive more than 600 million euros, and more than 1.3 billion euros have been earmarked for “the best creative scientists selected by the European Research Council.” The funding is part of the European Union’s new “Innovation Union Flagship” project and is expected to both encourage scientific innovation, foster a more competitive and sustainable Europe over the long term and create more than 165,000 new jobs.
Debate Continues Over Regulation of Consumer DNA Tests
Posted: 22 July 2010
Amid increasing debate over the validity and availability of genetic tests marketed directly to consumers (DTC), the US Food and Drug Administration (FDA) held a public meeting this week on laboratory developed tests, which included discussion of the proliferating DTC tests. Critics say some companies marketing the tests make broad, unsubstantiated claims, and test results may be too complex or simply unreliable. A panel of experts convened by FDA agreed that the tests carry different risks to the public than other, existing over-the-counter tests for things such as pregnancy or cholesterol. However, test makers and others argue the federal government should not restrict public access to genetic information.
Increasing FDA/EMA Cooperation Focuses on Specific Topics
Posted: 15 July 2010
Officials at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) say the agencies are increasingly sharing confidential information, using topic-specific groups to facilitate dialogue. Topic groups or “clusters” cover key areas including oncology, vaccines, orphan drugs, pediatrics, pharmacogenomics and veterinary products, and more may be added. The two agencies have had a formal information-sharing agreement in place since 2003 under which they share information and data related to new and pending applications. Approval decisions have remained independent. The agencies are expected to renew their agreement this September.
FDA Advisory Panel Delivers Mixed Vote on Avandia
Posted: 15 July 2010
A US Food and Drug Administration (FDA) advisory panel yesterday delivered a mixed vote on the diabetes drug Avanida, with most voting to either severely restrict usage or remove the drug from the market, because of increased risk of heart attack. Of the 33 panel members, 12 voted to withdraw the medication, 10 voted for restrictions, seven voted to add warnings and three voted allow continued marketing with no changes. One abstained. While FDA generally follows panel advice, this mixed verdict leaves the agency with a less clear recommendation, and the ultimate decision will be watched closely in light of Commissioner Margaret Hamburg’s stated commitment to drug safety and science-based decisions. Regulators in Europe and India are also taking another look at the drug.
India Could Make Cheaper HPV Vaccine Without Patent Violation
Posted: 15 July 2010
A new study indicates vaccine manufacturers in India and other developing countries may be able to produce cheaper versions of the vaccine for human papilloma virus (HPV) without infringing on existing patents. Researchers examined the complex array of patent protections related to the HPV vaccine and found that only 19 of the 86 patented technologies were patented in India. This is significant news for protecting against cervical cancer in India and other developing nations where the $300 price tag for brand-name Gardasil is beyond the means of most potential patients.
Biomarkers Could Lead to Alzheimer’s Breakthroughs
Posted: 15 July 2010
New biomarkers developed to diagnose Alzheimer's much earlier in the disease’s progression are likely to transform the entire approach to the disease and could lead to innovative new treatments. The biomarkers were developed and tested by expert panels convened by the National Institute on Aging and the Alzheimer’s Association. Diagnosis of Alzheimer’s has traditionally come at the onset of dementia, which is now viewed as a late stage in the progression of the disease. Experts now believe Alzheimer’s is present in patients a decade or more before they exhibit symptoms. The new biomarkers will make it possible to detect it at earlier stages through tests such as brain scans, MRIs and spinal taps.
High Costs Limit Biosimilars Development
Posted: 8 July 2010
While regulatory approval pathways are now in place for biosimilars, high R&D costs, complexity of production and legal issues continue to limit the number of companies able to enter the market. With total costs to develop, manufacture and market a biosimilar version of an established biologic drug around 50 times higher than the cost for a traditional generic, analysts say only five or six large companies will be capable of playing a role. Smaller companies, they say, won’t be involved at all.
Pay-for-Delay Deals Decline in Europe
Posted: 8 July 2010
The European Commission (EC) is reporting a decrease in pharmaceutical patent settlements that may violate European antitrust laws. In the 18 months from 1 July 2008 to 31 December 2009, only about 10% of the 93 settlement agreements were reached between originator companies and generic drugmakers, compared with 22% of the 207 deals during the previous seven and a half years (January 2000 to June 2008). The EC has been keeping a close watch on so-called pay-for-delay deals over the past few years, including launching a series of raids and an antitrust probe that ended last summer.
Devices Transmitting Data Pose Security Risks
Posted: 8 July 2010
Pacemakers and other medical devices that transmit health data wirelessly may expose private medical information to unauthorized individuals or possibly even interfere with treatments, according to members of the Medical Device Security Center. The wireless data transmission is intended make regular monitoring easier, allowing healthcare professionals to get feedback and adjust therapies accordingly. “These devices do increase the effectiveness of patient care,’’ said Kevin Fu, a director of the center. “The two main risks are access to private information and control of the device. Security and privacy have much room to improve for medical devices.’’
US Drug Prices Comparable to Europe, Says Study
Posted: 8 July 2010
Researchers at the London School of Economics argue in a new report that differences in prices for brand name drugs in the US and Europe are very small and the modest gap is continuing to narrow over time. The report undermines claims by the US pharmaceutical industry that drug research and development is disproportionately supported by US consumers paying higher prices than their European counterparts. The research team conducted a rigorous drug-by-drug comparison and their findings will be published in an upcoming article in Health Economics, Policy and Law.
FDA, CMS Cooperation Could Lead to Parallel Reviews
Posted: 1 July 2010
The US Food and Drug Administration (FDA) and US Centers for Medicare & Medicaid Services (CMS) agreed last week to share confidential data on device approval submissions, a possible first step toward parallel reviews that could result in simultaneous approvals by both agencies. CDRH head Jeffrey Shuren said the two agencies could eventually define circumstances under which FDA approval of a device would allow CMS to approve reimbursement without requiring additional evidence. The agreement will take effect next month.
FDA Issues Guidance on Studies for IVD Applications
Posted: 1 July 2010
The US Food and Drug Administration (FDA) issued its final guidance on studies supporting premarket applications for in vitro diagnostic (IVD) devices. The guidance document is presented in Q&A format and is intended to address frequently asked questions device makers have about developing and conducting IVD studies, and covers important data considerations for such studies. The original draft guidance was issued in October 2007.
Germany to Require Drugmakers to Negotiate Price
Posted: 1 July 2010
German Chancellor Angela Merkel’s Cabinet approved legislation this week that would compel drugmakers and health insurers to negotiate prices of new drugs, taking into account cost-effectiveness. The proposal would give drug companies the power to set a drug price unilaterally only if an agreement is not reached after 15 months. The bill, which in intended to save 2 billion euros per year on patented medicines, will now head to the Bundestag, the lower house of the German parliament for its approval.
Drug R&D Less Productive, Says Report
Posted: 1 July 2010
New drugs are making up an increasingly smaller portion of overall pharmaceutical sales, according to the 2010 Pharmaceutical R&D Factbook, released this week by CMR International. Drugs launched within the last five years represented less than 7% of global pharmaceutical sales in 2009, a drop from the 8% reported in 2008. As a result of the lack of research and development (R&D) productivity, many large drugmakers have begun to cut back on R&D operations. Total expenditures for R&D were down 0.3% in 2009, after a 6.6% increase the previous year and rapid growth in earlier years.
June
Report Raises Concerns Over FDA Monitoring of Foreign Trials
Posted: 24 June 2010
The US Department of Health and Human Services issued a report this week highlighting concerns about the number of clinical trials conducted outside the US and the US Food and Drug Administration’s (FDA) capacity to monitor such trials. According the report, 80% of drugs approved for US sale in 2008 were supported by foreign trials while FDA inspected just 0.7% of foreign clinical trial sites. The report encourages FDA to pursue more cooperation with foreign governments and explore “new models of oversight.” The European Medicines Agency recently issued a reflection paper on foreign trials with similar findings and recommendations.
EFPIA President Supports CER Role for EMA
Posted: 24 June 2010
The president of the European Federation of Pharmaceutical Industries and Associations (EFPIA) said this week he supports a greater role for the European Medicines Agency (EMA) in establishing the effectiveness of approved drugs, rather than leaving it to national authorities such as the UK’s National Institute for Clinical Excellence (NICE). Andrew Witty, who is also CEO of GlaxoSmithKline, said "There is a certain degree of appeal to having a rational evidence-based relative efficacy or effectiveness discussion once in Europe rather than having it 27 times and potentially answered 27 different ways.”
FDA Urges Drugmakers to Explore Drugs for Rare Diseases
Posted: 24 June 2010
The US Food and Drug Administration (FDA) is encouraging drugmakers to explore whether existing, approved medicines may help treat neglected disorders. This comes after an FDA incentive program did not result in research on new therapies as agency officials had hoped. To spur action by drugmakers, FDA published a list of 235 approved treatments that could possibly benefit patients with rare disorders and already have marketing clearance for other uses.
CDRH Chief Says 510(k) Changes Coming Soon
Posted: 24 June 2010
According to Director of the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, the results of the agency's comprehensive review of its 510(k) clearance program will be out in a few weeks. Shuren told the audience at the latest in a series of "town hall" meetings held near Boston this week that CDRH would seek public comments before implementing any changes to the program. He did not say what changes would be recommended. "What we’ve been saying so far is not anything about what changes we’re going to make,” said Shuren. "The only thing I’m very clear about is we’re not recommending to get rid of the 510(k) program."
FDA Proposes Tougher Regulation of Outsourcing
Posted: 17 June 2010
The US Food and Drug Administration (FDA) may begin holding pharmaceutical companies more accountable for outsourced manufacturing operations, including requiring drugmakers to conduct inspections of their contractors' facilities instead of relying solely on reported data. FDA is also considering issuing warning letters to both drugmakers and their contractors when manufacturing problems are found instead of just sending them to the contractors.
Rise in Drug-Resistant Diseases Requires Action
Posted: 17 June 2010
A negative side effect of efforts to distribute lifesaving drugs in developing countries is an increase in drug-resistant diseases, and coordinated, global action is necessary to combat the problem, says a new report. The report from the Center for Global Development found that drug resistance is being driven in many countries by drug misuse and weak healthcare systems. While some countries have made attempts to overcome the problem, the report calls for a “systemic global response.”
NIH, FDA Coordinate Efforts to Support Personalized Medicine
Posted: 17 June 2010
Writing in the New England Journal of Medicine, the heads of the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) laid out their plans to help to expedite the development of gene-therapy drugs and diagnostics for personalized medicine. In their commentary, FDA Commissioner Margaret Hamburg and NIH Director Francis Collins committed their agencies to investing in efforts to establish a clear regulatory path for both drugs and diagnostics that encourages innovation while ensuring patient safety.
India to Require Regulatory Checks of Devices
Posted: 17 June 2010
The Indian government will begin requiring regulatory checks of all medical devices marketed in the country under a comprehensive amendment to current drug law. Historically, only the few devices categorized as drugs in India have been required to be registered with the Drugs Controller General of India (DCGI) and subject to regulation. However, with the new legislation, medical device manufacturers and importers will have to register all devices with DCGI.
Report Urges Changes at FDA
Posted: 10 June 2010
A report from the Institute of Medicine and the National Research Council says the US Food and Drug Administration (FDA) is ill equipped to handle food supply problems. Among other things, the report urges FDA to proactively focus on identifying and addressing high-risk areas to prevent outbreaks of foodborne illnesses. It also recommends giving the agency the authority to issue mandatory recalls of food products and to delegate responsibility for inspections to states. Many of the recommendations in the report would be met under food safety legislation passed last year by the House. The Senate has yet to act on its bill.
EU Drugmakers Anticipate Parallel Trade
Posted: 10 June 2010
In the wake of medicine price cuts in Greece last month, EU drugmakers are anticipating an increase in parallel trade. Parallel trade allows pharmacists, distributors and other traders to buy lower-priced drugs in one country and sell them elsewhere at a markup that is still below established prices in higher-cost Member States. “The Greek prices would be lossmaking and our medicines would travel to other markets in a completely uncontrolled fashion,” said Lars Sorensen, chief executive of Novo Nordisk.
WHO DG Denies Industry Influence on Flu Guidance
Posted: 10 June 2010
A report from the Council of Europe criticized the World Health Organization (WHO) and EU agencies and governments for their handling of the H1N1 flu pandemic. This followed a joint investigation by the British Medical Journal (BMJ) and The Bureau of Investigative Journalism recently published in BMJ. That investigation reported researchers advising WHO over preparations for the pandemic had worked for drugmakers “who stood to gain from the guidance these scientists were preparing.” Dr. Margaret Chan, WHO director-general, responding to the BMJ article in writing, stated, “At no time, not for one second, did commercial interests enter my decision making.”
Fighting Cancer With Nanoparticles
Posted: 10 June 2010
Scientists at the Scripps Research Institute are using glycoproteins paired with nanoprticle liposomes loaded with doxorubicin to target and destroy one type of cancerous cell. Professor James Paulson and his team are targeting B cells, and hope their findings may lead to new therapies to treat lymphomas, leukemia and related cancers. “We are very interested in moving this technology forward to see if it would be applicable to treatment of humans and to investigate other applications for this kind of targeting,” said Paulson.
More Biologics Manufacturing to be Outsourced
Posted: 3 June 2010
Large pharmaceutical companies will increasingly outsource production of biologics, helping reduce costs and speed development, says a new report. While drugmakers have traditionally avoided outsourcing of biologics manufacturing, contract manufacturing organizations (CMO) have increased their biologics expertise and capabilities in recent years, helping allay the regulatory and quality concerns that have led drugmakers to keep biologics manufacturing operations largely in-house until recently.
US Congress Broadens Probe of J&J
Posted: 3 June 2010
Johnson & Johnson is under increased scrutiny as the US Congress has broadened its investigation of the company after allegations of a “phantom recall” of Motrin IB packets came to light. Congress had been looking into J&J’s recent recall of more than 130 million bottles of children’s medicine when it was revealed that in 2008, the company’s McNeil unit hired contractors to buy stocks of Motrin packets that had a possibility of reduced potency. Contractors were reportedly instructed to act like regular consumers. J&J contends purchases were made for the purpose of conducting tests to determine whether a recall would be necessary. The investigating committee has asked for all records related to the incident.
US Supreme Court Considers Generic Preemption Case
Posted: 3 June 2010
This week, the US Supreme Court asked the Obama administration for its views on whether generic drug companies can be sued in state courts for allegedly inadequate labeling. Generic drugmakers argue that federal law preempts state law, providing immunity from such lawsuits. The case involves a woman who says she developed a severe neurological movement disorder after taking a generic version of a heartburn drug. The appeal comes after an Eighth Circuit Court decision in November found that the limits on preemption established in 2008’s Wyeth v. Levine case also extend to generics makers.
EMA Addresses Ethics, GCPs of Trials Outside Europe
Posted: 3 June 2010
The European Medicines Agency (EMA) recently released a reflection paper addressing ethical and Good Clinical Practice (GCP) issues related to clinical trials conducted in countries that do not belong to the EU or the European Economic Area. Drug marketing applications submitted in Europe increasingly include data from non-European clinical trials, which are difficult for European authorities to directly monitor. The paper addresses this challenge and calls for increased cooperation and communication between international regulatory authorities. EMA will be accepting comments on the paper through 30 September 2010.
May
As NICE Recommends First Biosimilar, US Pathway Questioned
Posted: 27 May 2010
The UK’s National Institute for Health and Clinical Excellence (NICE) issued its first recommendation for a biosimilar product this week, while in the US, questions have arisen about the usefulness of the new biosimilar approval pathway itself. NICE gave its approval—based on cost effectiveness—to a biosimilar product already approved by the European Medicines Agency as safe and effective, to treat growth deficiencies in children. Meanwhile, some are casting doubt upon the usefulness of the new biosimilar approval pathway created by the US healthcare reform law, citing several advantages of a conventional Biologics License Application over the new pathway.
FDA, NIH Launch Safety Reporting Website
Posted: 27 May 2010
The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched a new website allowing users to report safety problems related to food (including animal feed), veterinary drugs and human gene transfer trials. Eventually, the portal will allow reports for other types of clinical trials and safety issues for products regulated by other federal agencies, according to an FDA statement. “The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said FDA Commissioner Margaret Hamburg.
FTC Chief Promises Action on Pay-for-Delay Deals
Posted: 27 May 2010
Stopping “pay-for-delay” deals where a brand-name drugmaker pays to delay introduction of a generic version is one of the US Federal Trade Commission’s (FTC) highest priorities, FTC Chairman Jon Leibowitz told a Senate subcommittee. Such deals cause “enormous consumer harm,” said Leibowtz, limiting competition and raising costs for American consumers, businesses and government. It is estimated that pay-for-delay deals cost the American public $3.5 billion or more per year.
Innovative Stem Cell Project Offers Hope for Motor Neuron Disease
Posted: 27 May 2010
British scientists have launched a groundbreaking project using stem cells to recreate and study a devastating and incurable neurological disease in the laboratory. Researchers in London and New York will create stem cells carrying a genetic mutation responsible for motor neuron disease (MND) and observe how the disease kills off healthy nerve cells and spreads. It is nearly impossible to study MND this way in living patients and the hope is that this research will provide previously impossible insight into a disease that currently has few effective treatment options. The most common form of MND is amyotrophic lateral sclerosis (ALS), also known as or Lou Gehrig’s disease.
FDA Proposes New Disclosure Rules
Posted: 20 May 2010
The US Food and Drug Administration’s (FDA) Transparency Task Force released 21 draft proposals this week that would disclose more information to the public about such things as drug rejections, plant inspections and detailed side-effect reports. The proposed disclosure policies are part of the second phase of FDA’s transparency initiative intended to increase public understanding of how the agency operates and makes decisions. FDA will be accepting public comments on the proposals until 20 July.
India, Thailand Ask WHO to Stay Out of Intellectual Property
Posted: 20 May 2010
India and Thailand have called upon the World Health Organization (WHO) to focus its efforts on improving access to safe, effective and affordable medicines in the developing world, not protecting drugmakers’ intellectual property. The nations are asking WHO to end its involvement in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which critics say has conflicts of interest and is being manipulated to protect intellectual property rights.
CDRH Chief Hears From Stakeholders at Town Hall Meeting
Posted: 20 May 2010
Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), met with members of the medical technology community in Minnesota this week in a town hall meeting. Many of the estimated 400 attendees politely criticized what they see as the shortcomings of the FDA device approval process, including lack of predictability, bloated timelines and unprepared, unresponsive agency staff. Shuren addressed the 510(k) review program, saying that the program would continue but that changes would be announced in a few weeks.
Spain to Impose Drug Price Cuts
Posted: 20 May 2010
In an effort to rein in its massive budget deficit, Spain will cut the prices of a wide range of patented prescription drugs, which officials say will save the country around 1.3 billion euros. Industry critics say the measure will severely damage Spain’s pharmaceutical industry, putting 20,000 jobs in jeopardy. An industry group spokesman said medicine prices in Spain are already 23% below the EU average, and suggested raising copayments as an alternative measure. Drugs currently make up 32% of Spain’s total healthcare expenditures.
FDA Encourages Docs to Report Misleading Drug Promos
Posted: 13 May 2010
The US Food and Drug Administration (FDA) this week launched a program to encourage doctors to report misleading pitches from pharmaceutical salespeople in the field. The effort, dubbed the “Bad Ad Program” by FDA, will begin with agency representatives engaging healthcare providers at select medical conventions and partnering with medical organizations to educate doctors on how to spot the questionable practices. FDA staffers check print and broadcast advertising and medical journals for misleading material, but until now have been unable to monitor face-to-face interaction between doctors and drug company representatives.
EMA, FDA, Drugmakers, Academics Team Up on Drug Tests
Posted: 13 May 2010
An unprecedented collaboration between the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), scientists at 17 companies and academic researchers could streamline the drug testing and approval process. The project, called the Predictive Safety Testing Consortium, aims to find simple measures that will indicate whether a drug is likely to cause serious side effects, and then share the information among drug developers and regulators. As its first project, the group chose a panel of biomarkers to predict kidney injury from experimental drugs.
Drugmakers Must Be Cautious In Use of Unbranded Websites
Posted: 13 May 2010
Some drugmakers and other healthcare product companies have begun to explore the use of unbranded websites to engage consumers around specific diseases or health issues. A recent report looks at this approach as a possible way to engage with patients in a more relatable way as part of a company’s relationship marketing strategy. At the same time, the US Food and Drug Administration (FDA) recently sent a Warning Letter to a large drugmaker over company-operated educational websites, and the agency is feeling pressure from consumer groups to monitor stealth marketing efforts designed to eavesdrop and analyze conversations by and among health consumers.
EMA Urged to Release Adverse Reaction Reports
Posted: 13 May 2010
The European Ombudsman vehemently disagrees with the European Medicines Agency’s (EMA) insistence that EU transparency rules do not apply to adverse drug reaction (ADR) reports and has urged the agency to release documents relating to possible ADRs. The case in question concerns an Irish citizen who requested reports of possible ADRs from a nationally authorized acne drug more than two years ago. EMA refused to allow access, arguing that transparency laws are not applicable. Reported reactions include a potential increased risk of suicidal tendencies in patients taking the drug.
Biosimilar Pathway a Priority for FDA
Posted: 6 May 2010
The US Food and Drug Administration (FDA) will convene a work group to establish the approval pathway for biosimilars, and the agency plans to issue guidance on the topic, according to Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER). The recently passed US healthcare reform legislation contains provisions to allow FDA to approve biosimilars. “People want to understand the pathway”, said Woodcock. “We're open for business but realize many people will need more guidance on how to have biosimilars approved.”
EU and US Medical Device Regulation Reexamined
Posted: 6 May 2010
As medical devices have become increasingly complex and usage has grown, both EU and US device regulations are being reexamined and reconsidered. The EU recently revised its device regulatory system, which had been unchanged since 1998. The revisions came into force in March. US regulations under the US Food and Drug Administration (FDA) have been revised periodically since their 1976 creation, but the entire system is currently being reviewed by FDA in cooperation with the Institutes of Medicine (IOM) of the National Academies, and may be overhauled.
RAPS Partners With Chinese University to Develop Courses
Posted: 6 May 2010
RAPS has entered into an agreement with the University of Shanghai for Science and Technology (USST) to work collaboratively in developing regulatory education content for the university. RAPS will provide some of the existing online course content currently offered through its Online University, which will be adapted for USST’s students, as well as guide the university in developing new regulatory curricula and provide advice and support to university faculty. The focus initially will be on medical devices, but could expand to cover pharmaceutical or other medical products in the future.
FDA Announces Latest Safety Investigations
Posted: 6 May 2010
The US Food and Drug Administration (FDA) released its quarterly list of adverse event safety investigations covering the period from October through December 2009. Among the issues FDA is looking into are reports of liver toxicity in patients using a drug to prevent HIV infection after exposure to the AIDS virus, and cases of male breast cancer in patients treated with certain prostate and baldness drugs. A product’s inclusion on the list means FDA has identified a potential safety issue, but not that it has established a causal relationship between the drug and the listed risk.
April
China’s Healthcare Reform Presents Opportunities
Posted: 29 April 2010
As China undergoes sweeping, unprecedented changes to its antiquated healthcare system, opportunities for Chinese and foreign healthcare companies are beginning to emerge. The government has put more than $586 billion (US) into an economic stimulus package to upgrade infrastructure and boost social welfare, and devoted another $124 billion to healthcare reform. Observers say the medical device market there could be poised for strong growth, and Chinese regulations are being modified to make the country a more attractive place for clinical trials.
EU to Overhaul Clinical Trials Directive
Posted: 29 April 2010
The EU executive is planning a major overhaul of its Clinical Trials Directive, which is widely viewed as a hindrance to clinical trials, adding costs and bureaucracy. The European Commission plans to fix the flawed directive by October 2011. However, officials are unsure if they simply need to clarify elements of the existing directive or craft a brand new regulation that would better address the existing rule's inconsistencies.
EMA Committees Overwhelmed, Says Report
Posted: 29 April 2010
The two main committees driving regulation by the European Medicines Agency (EMA) are “overwhelmed with work,” according to a new report on the agency. The workloads of EMA’s Committee for Medicinal Products for Human Use (CHMP) and its counterpart for veterinary drugs (CVMP) are just about at maximum capacity, says the report from Ernst & Young. It recommends setting up two dedicated committees to deal with referrals and generics, respectively. The mostly positive report is the result of a year-long evaluation.
FDA Chief Stresses Collaboration With USP on Monographs
Posted: 29 April 2010
The US Food and Drug Administration (FDA) and the US Pharmacopeia (USP) need to work in ongoing, close collaboration on the modification of monographs in order to prevent contaminated products from entering the healthcare system, said FDA Commissioner Margaret Hamburg. The need to remain vigilant against the threat of counterfeit or adulterated products was illustrated by the Heparin contamination crisis two years ago.
Biotech Awaits Impact of US Healthcare Reform
Posted: 22 April 2010
While it is too early to declare whether US healthcare reform will be a net positive for the biotechnology industry, it is certain to have a profound impact. Passage of the Patient Protection and Affordable Care Act creates for the first time a detailed approval pathway for biosimilars in the US. It also establishes new fees for brand-name drugs and new taxes on medical devices. There are so many variables at play, analysts and biotech executives alike appear to be taking a ‘wait and see’ approach as to its ultimate effects.
EU Price Controls, Expiring Patents to Hinder Drug Sales
Posted: 22 April 2010
The worldwide sales growth of pharmaceuticals is expected to slow this year because of expiring patents and a move to tighter price controls in Europe. A new report from a healthcare industry research company estimates global prescription drug sales growth to be between 4–6% compared with 7% in 2009. Drugmakers have been unable to replace blockbuster drugs developed in the 1990s with similarly profitable new, innovative products.
Nigeria, China to Work Together to Battle Counterfeit Drugs
Posted: 22 April 2010
Representatives from Nigeria's health authorities recently traveled to China to meet with Chinese leaders to discuss ways to better combat drug counterfeiting and support Nigerians’ access to authentic, good-quality drugs. The working visit represents a proactive step in addressing the growing influx of fake drugs. Several Chinese companies have been identified as sources. A similar trip to India is also planned.
Heart Device Failure Case Raises Accountability Questions
Posted: 22 April 2010
Two Minneapolis cardiologists have raised a fundamental question about medical device safety and who should be held accountable when a company sells a flawed, dangerous product. In such cases, companies often strike plea deals and end up paying a significant fine, but company officials typically do not face criminal prosecution. The two doctors are calling for greater personal responsibility in such cases by those who run the companies.
Researchers Reexamining Hallucinogens
Posted: 15 April 2010
Researchers are taking another look at possible therapeutic uses for hallucinogens, a category of drugs that has been off limits to mainstream medicine since the 1960s. Researchers believe certain hallucinogens can be used to treat a number of psychiatric conditions and regulators are once again granting approval for controlled experiments using rigorous protocols and safeguards. Despite this, little money is yet available to support such research.
FDA Approval Causes Price Hike for Old Treatment
Posted: 15 April 2010
When an unapproved drug that had been in use for years to treat gout received approval by the US Food and Drug Administration (FDA), the treatment suddenly became as much as 25 times more expensive. Colcrys, the brand-name version of colchicine, a gout drug that predated FDA’s existence, costs patients as much as $125 to $150 per month, up from $5 to $10 a month for the previously unapproved version. In addition, other unapproved versions still being sold have become more expensive as well.
Oversight of Medical Smart Phone Apps Under Consideration
Posted: 15 April 2010
Physician use of medical smart phone applications is becoming increasingly common in the practice of medicine and regulatory agencies must consider how much oversight is appropriate. Medical applications are technically medical devices, but there are not yet any explicit guidelines in place from the US Food and Drug Administration (FDA) or other agencies. FDA is currently considering various degrees of oversight. According to Jeff Shuren, director of FDA's Center for Devices and Radiological Health, regulation could focus on postmarket safety using an electronic registry.
Quebec Could Sue Drugmakers Over Ontario Rebate Deal
Posted: 15 April 2010
Canada’s provincial government of Quebec may sue drugmakers after learning that they paid significant rebates to the government of Ontario in violation of a price-match deal negotiated four years ago. The agreement between Quebec and pharmaceutical companies requires drugmakers to match the lowest price for prescription drugs anywhere in Canada for Quebec’s publically-funded drug benefit program. However, the Ontario rebates have dropped prescription drug prices there to as much as 40% below the market rate. Officials in Quebec say the province was cheated.
FDA Seeks Consumer Reps for Advisory Committees
Posted: 8 April 2010
The US Food and Drug Administration (FDA) has put out a call for consumer representatives to serve on its advisory committees. According to an FDA statement, advisory committee members need not be doctors, scientists or a healthcare professionals but must exhibit “a desire to advocate on behalf of the public” or have strong ties to consumer or community-based organizations. The agency will hold a public meeting 30 April for those interested.
Drugmakers Decry Price Controls in Germany
Posted: 8 April 2010
Drugmakers have sharply criticized the German government’s plan to impose price controls on new drugs, calling the move “devastating” for investment in the country. The new rules will require manufacturers of new medicines to provide evidence of cost/benefit superiority over currently available treatments to provide the basis of price negotiations with insurers. Companies would be permitted to set the drug’s price for the first year after its launch but insurers could impose a mandatory short-term rebate of as much as 16%, an increase over the current rate of 6%.
Drugmakers Step Cautiously Into Social Media
Posted: 8 April 2010
Pharmaceutical companies are devoting increasing attention to social media outlets in their promotional efforts, despite a lack of guidance from regulators. Social media initiatives now account for about 5% of drugmakers’ promotional spending, according to one professor of pharmaceutical marketing at St. Joseph’s University in Philadelphia. The US Food and Drug Administration (FDA) has expressed concern about the use of social media to disseminate misleading or incomplete promotional information and held a public meeting on the subject last autumn, but has yet to issue any formal guidelines.
Proposed Ohio Cloning Ban Could Impact Research
Posted: 8 April 2010
An Ohio senator has reintroduced legislation to ban cloning that stem cell researchers say will hamper their work and hurt the state’s biotechnology industry. Critics of the proposal point out the distinction that the bill fails to make: that of reproductive cloning—creating humans––vs. therapeutic cloning for research purposes, which can lead to breakthroughs in medical treatments. If passed as currently written, the bill’s broad language could have a chilling impact on research throughout the state.
Judge Nullifies Patents on Two Human Genes
Posted: 1 April 2010
A federal judge’s decision Monday, striking down patents on two genes linked to breast and ovarian cancer could throw the patents covering thousands of human genes into doubt and is causing anxiety in the biotechnology sector. The decision by US District Judge Robert Sweet challenging whether anyone can hold patents on human genes was expected to have broad implications for the biotechnology industry and genetics-based medical research. The judge said his findings were consistent with Supreme Court rulings that have established that purifying a product of nature does not mean it can be patented. The ruling came in a long-running fight between scientists who believe genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward.
Pharmaceutical Reform Bill in Russian Parliament
Posted: 1 April 2010
A bill has just gone through the Russian parliament, the Duma, aiming to rekindle development of the domestic pharmaceutical industry. If passed, following a third reading in September, it will set a maximum price on 500 drugs including treatments for tuberculosis and diabetes—a move designed to make them more affordable. Included in the new measures are plans that would require authorities to publish a price list at every pharmacy. Another important measure aims to protect the market from counterfeit medicines and ensure companies that manufacture drugs in Russia comply with European quality standards by 2014.
CDRH Managers Cleared
Posted: 1 April 2010
The US Food and Drug Administration announced Tuesday that the HHS inspector general has found that managers at the Center for Devices and Radiological Health did not engage in criminal actions against scientists who opposed the approval of several medical devices. The allegations concerned approvals of some medical devices over the objections of veteran doctors and scientists inside the agency. Some reviewers had alleged that managers had retaliated against them, that approvals had not been documented appropriately, and that decisions were influenced by the industry or politicians. In 2008 and 2009, a group of whistleblowers wrote to Congress and President Barack Obama that the device division was "fundamentally broken." They complained their jobs were affected after they had raised their concerns.
WHO Invites Comments on Draft Guideline
Posted: 1 April 2010
The World Health Organization (WHO) has issued the proposed guidance, Guideline for the Production and Control of Specified Starting Materials. The document focuses on those materials used as or in the production of active pharmaceutical ingredients (APIs) and aims to offer a global approach to defining quality. The guidance details quality levels for some materials and states that for others a risk assessment, considering such factors as the number and nature of synthesis steps, may be suitable. Comments on the document can be submitted until 1 May and those received by 23 April could be discussed at the consultation on paediatrics and generic guideline development.
March
Drugmakers to Benefit From US Healthcare Reform
Posted: 24 March 2010
As an early supporter of President Obama’s effort to pass healthcare reform, the pharmaceutical industry stands to be one of the biggest beneficiaries of the legislation passed this week by the US House and Senate. Drugmakers successfully traded short-term concessions for long-term gains. For agreeing to contribute $80 billion worth of cost savings up front, drug companies could recoup as much as $115 billion in new business over the next 10 years. Makers of novel biologics also scored 12 years of market exclusivity for innovator biologic drugs, which the President had originally favored granting seven years of protection, effectively maintaining a high barrier to market entry for biosimilars.
Unique Collaboration Could Speed Cancer Drugs to Market
Posted: 24 March 2010
A unique, new collaboration among several drugmakers, the US government and nonprofit groups could help get breast cancer drugs to patients more quickly. The five-year, $26 million study called Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, will attempt to use DNA to match the best drug to each patient and to more quickly eliminate those that do not work or are too toxic. In an unusual arrangement, the companies have agreed to share information on the DNA testing as part of the Biomarkers Consortium, which also includes the US Food and Drug Administration (FDA) and the National Institutes of Health. Up to 12 different cancer drugs will be tested. Also unique, FDA will allow the study to drop and add drugs throughout the course of the trial without having to stop to write a whole new protocol.
Theranostics Underutilized by Drugmakers, Says Report
Posted: 24 March 2010
The field of theranostics, which helps to determine the best drug for a given patient, is going to become increasingly important for drugmakers but is currently underutilized, argues a new report. Theranostics is the science of developing molecular assays to help predict the most suitable drug for a patient and assess its efficacy. As pharmaceutical companies increasingly explore applications for personalized medicine, they will need to strengthen their expertise in this key area. According to the report from Frost & Sullivan, theranostics “plays a crucial role in every step of drug development process, primarily in the form of biomarker discovery, target selection and validation of biomarkers.” Its key applications are in cancer, cardiovascular diseases and neurological disorders.
Drugmakers to Send Vaccines to Poor Nations
Posted: 24 March 2010
Pfizer and GlaxoSmithKline signed a landmark 10-year deal this week to supply 60 million doses per year of pneumococcal vaccines to developing nations at deep discounts. The deal, brokered by the Geneva-based Global Alliance for Vaccines and Immunization (GAVI), is the first under a new scheme called an Advance Market Commitment, which guarantees a market for vaccines supplied to poor nations but sets a maximum price drugmakers can receive. GSK and Pfizer committed to supply the vaccines at $7 per dose for the first 20%, and $3.50 per dose for the rest, compared with retail values of between $54 and $108. GAVI estimates the vaccines could save up to seven million lives by 2030.
Regulatory Workload Up at Drug R&D Companies
Posted: 18 March 2010
As drug development activity continues to rise across the world, the workload for regulatory professionals at pharmaceutical and biotechnology companies has dramatically increased, according to a new study. The study from the Tufts Center for the Study of Drug Development found that the regulatory function within drug development firms has grown steadily over the past decade, with most tending to hire from within. Researchers say that with more clinical trial work being outsourced, regulatory professionals are increasingly needed to coordinate and communicate with external providers, overseeing the whole process while improving efficiencies. The study also found that regulatory departments support an average of 100 major projects per year, two-thirds of which are in clinical research phases.
FDA Reconsidering Third-Party Reviews for Devices
Posted: 18 March 2010
As the US Food and Drug Administration (FDA) reevaluates its approval process for medical devices, the agency is taking a critical look at its third-party review program. Intended to improve efficiency and save time and money, the program allows accredited third parties to conduct the primary review of certain eligible devices as part of FDA’s 510(k) review process. But the program has been criticized within the agency as officials question the quality of the reviews and whether they have actually served their intended purpose. An FDA official said last year that there is a perception that the third-party review is a friendlier process. Private reviewers and the device industry have responded by defending the quality of the outside work and pointing out that FDA still maintains its authority over the final approval decision.
"Pharmerging" Markets Grow in Number, Importance
Posted: 18 March 2010
Pharmaceutical industry growth is continuing to shift to the so-called "pharmerging" markets. The number of high-growth pharmaceutical markets within emerging market economies has grown to from seven to 17, and their overall sales are predicted to grow by $90 billion during the 2009-2013 period, contributing 48% of annual market growth in 2013 compared to 37% in 2009, according to a market research report. By comparison, growth rates of more mature pharmaceutical markets will continue to decline as they face high rates of patent expiration and increased use of generics, underfunding of the biotech sector, changes in reimbursement schemes and tighter government restrictions related to product safety and pricing, says the report.
South Korea Poised to Lead on Biosimilars
Posted: 18 March 2010
Last year, South Korea created a regulatory pathway for follow-on versions of biologic drugs, or "biosimilars." Now, local and foreign companies have begun to invest in developing biosimilar products there, causing some to predict the country is set to emerge as a global leader in biosimilars. South Korean electronics giant Samsung has committed to invest $389 million (US) in biosimilars and indicated it would be aggressive in the area. The country has also already hosted a successful clinical trial of a biosimilar version of a rheumatoid arthritis and psoriasis drug from a Taiwanese drug development company, and there is an agreement in place between a US drugmaker and a South Korean counterpart to develop and co-market eight biosimilar medicines. South Korea’s long history in manufacturing biologics also makes it an attractive place for further development of biosimilars.
FDA Goes on the Road to Promote Orphan Drug Development
Posted: 11 March 2010
In an effort to encourage the development of drugs for rare diseases, the US Food and Drug Administration (FDA) has begun a series of workshops outside the Washington area to provide regulatory advice for potential drug sponsors. The first such workshop was recently held in California and another is planned for August at the University of Minnesota. The agency may even hold one in Europe. While the Orphan Drug Act gives companies incentives to create therapies for those diseases that affect fewer than 200,000 patients in the US, treatments exist for only a small fraction of the approximately 7,000 such conditions. Companies want to have a reasonable expectation of making a profit before they begin the expensive development process. The workshops help give potential sponsors feedback on issues that could delay or derail applications.
German Health Minister to Propose Drug Price Controls
Posted: 11 March 2010
In a move to save on healthcare costs, German Health Minister Philipp Roesler intends to compel brand-name drugmakers to negotiate lower prices directly with insurers, according to a German magazine report. The proposed plan would impose a price ceiling on drug companies if they fail to negotiate and is intended to save two billion euros annually. Germany, along with the UK, has been one of Europe's last free upfront drug pricing markets, allowing companies a large measure of control over setting new drug prices.
Report Cites Lack of Comparative Effectiveness Studies
Posted: 11 March 2010
While much has been made of the notion of comparing the effectiveness and cost value of various medical treatments, there currently is little such research being conducted, according to a report this week in the Journal of the American Medical Association. Researchers looked at 328 drug studies published in major medical journals. They found most such research being done at academic institutions or by other noncommercial enterprises. The researchers found most research simply tested whether one drug is better than another and did not compare the drugs to alternative treatments. Less than 20% examined safety and just 2% included an analysis of cost effectiveness.
Expiring Patents Will Slow Pharma Market Growth in Belgium
Posted: 11 March 2010
The expiring patents of a number of brand-name drugs will slow growth in Belgium’s pharmaceutical market to about 0.46% per year through 2014, according to a new forecast. This is down from 3.4% average annual increases between 2004 and 2009. This is bad news for the branded drug industry in Belgium, a market with high per-capita drug spending. Last year the Belgian drug market was worth 4.59 billion euros and will be worth 4.75 billion euros in 2010, falling to 4.57 billion euros in 2013 as medicines continue to lose patent protection, says the report. Sales are predicted to climb upward again beginning in 2014, with growth forecast for biologic drugs and personalized medicines.
FDA to Increase Criminal Prosecutions
Posted: 4 March 2010
The US Food and Drug Administration (FDA) plans to increase criminal prosecutions of pharmaceutical and food industry executives, according to FDA Commissioner Margaret Hamburg. The statement came in a letter to Sen. Chuck Grassley (R-IA), saying an internal committee has recommended that FDA "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool." The agency has the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability,” but the provision has not been used much in recent years.
Campaign Seeks to Limit Risk From CT Scans
Posted: 4 March 2010
A nationwide push is underway in the US to lower radiation exposure from CT scans, amid growing concern about increased cancer risks associated with the high-powered imaging technology. Studies show that a third or more of scans may be unnecessary and in scans that are medically appropriate, radiation doses could be dramatically reduced without hurting the quality of the images. The Society for Pediatric Radiology is sponsoring an “Image Gently” campaign to promote use of the smallest amount of radiation possible during an imaging study. The group also is urging radiologists to take other precautions, including covering areas of the body such as reproductive organs, and to consider alternative tests such as ultrasound.
DTC Drug Ad Spending Up 2%
Posted: 4 March 2010
Drugmakers’ spending on consumer advertising last year rose 1.9% to $4.5 billion from 2008, according to the latest Nielsen data. Spending on the two largest categories was mostly unchanged, with television up just 0.6% and advertising spending in national magazines down 0.6%. Broadcast television spending fell nearly 6%, while spending on cable networks continues to increase significantly. A Nielsen executive cited longer advertisements due to pressure from the US Food and Drug Administration to present more balanced risk/benefit information as one reason for the increase. Newspaper advertising spending was up 11% to $162 million and radio spending more than doubled to $46 million. Spending on Spanish-language cable networks was up 409% to $4 million and Spanish-language broadcast television spending increased 294% to $29 million. Internet advertising rose 31%to $117 million.
Concerns Grow Over Metal Hip Implants
Posted: 4 March 2010
The type of hip implants known as “metal on metal” implants have raised concern that they are causing severe tissue and bone damage in some patients, and some orthopedic surgeons have ceased using them altogether. In some cases, the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, were thought to be more durable than previous types of implants and became widely used in recent years. The studies conducted thus far have been limited, but estimate that 1–3%of implant patients could be affected by the problem, meaning thousands in the US alone.
February
Generics Review Time Up, User Fees Could Help
Posted: 25 February 2010
The US Food and Drug Administration (FDA) is taking much longer to approve new generic drugs today compared to five years ago and FDA Commissioner Margaret Hamburg believes user fees for generic drugs can help. Five years ago, FDA’s average time to approve a new generic was 16.3 months, but by last year, such approvals took an average of 26.7 months. The delays have been caused by a growing backlog of applications and limited staff to review them. Hamburg said last week that the agency’s generic drugs department was underfunded and that collecting user fees from generic drug sponsors could help alleviate the situation.
EMA Seeks Closer Ties With Health Tech Assessors
Posted: 25 February 2010
As part of the European Medicines Agency's five-year strategy document, the "Road Map to 2015," the agency is seeking closer ties with national-level health technology assessment (HTA) bodies, including the UK’s National Institute for health and Clinical Excellence (NICE). The agency recently launched a series of workshops with European HTA bodies to discus how to involve them earlier in the drug development process. European regulators are concerned about the confusion that could result from the appearance of having two parallel systems with slightly different requirements: one focused on clinical risks and benefits, and the other on relative effectiveness and cost benefits.
510(k) Approval Process for Devices Scrutinized
Posted: 25 February 2010
The US Food and Drug Administration (FDA) held a daylong public hearing last week to collect input to strengthen the 510(k) premarket notification process for review of medical devices. Most medical devices are approved in the US through 510(k), but the process has been under increasing scrutiny from both outside and within FDA. The program is often called a "fast-track" program because it relies on previous approvals of similar devices. Critics charge that this approach isn’t rigorous enough. Others fear that changes to the system might create a burdensome process that could stifle the innovation often driven by small start-up companies.
NIH, FDA Announce Plan to Speed Innovative Treatments
Posted: 25 February 2010
The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new partnership intended to help speed up the process of bringing innovative medical therapies to patients. According to FDA, the initiative involves the interrelated scientific disciplines of translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. The agencies will establish a Joint NIH-FDA Leadership Council to coordinate the efforts, and to help ensure that regulatory considerations are taken into account in biomedical research planning and the latest science is integrated into the regulatory review process. NIH and FDA will also make $6.75 million available over the next three years to help fund regulatory science research.
Biopharma Companies in Listening Mode on Social Media
Posted: 18 February 2010
While most of the technology business world has embraced social media strategies, biotechnology companies remain in more of a listening mode. Biotechs and other life sciences companies naturally have been slow to take a proactive role because of the highly regulated world in which they do business. Anything that may be perceived as promotional in nature risks inviting scrutiny from regulatory agencies such as the US Food and Drug Administration (FDA). As was seen last March, FDA sent out a rash of warning letters to a group of large drugmakers in a single day because the companies’ Google search ads did not include information about drug risks.
Patents Still an Obstacle to Brand Name Drugmakers in India
Posted: 18 February 2010
Drugmakers have had their eyes on India as a prospective growth market for some time but the Indian patent system remains a stumbling block. India’s growing healthcare spending, a relatively inexpensive pool of skilled labor and many potential local partners have attracted a lot of investment from many large pharmacuetical companies. However, patents are still much harder to come by there, compared with other markets. Just last week, the Delhi High Court refused to block approval of a copycat version of a brand name cancer drug. This is only the latest example of a top-selling drug being denied patent protection or, in some cases, enforcement. Drugmakers want greater protections, but Indian officials say their system is fair.
Counterfeit Drugs a Serious Problem in Middle East
Posted: 18 February 2010
Sale and distribution of counterfeit drugs remains a widespread and dangerous problem in the Middle East. A recent seizure of fake drugs in Syria provides some inkling of the scale of this problem. The haul netted millions of dollars worth of phony breast cancer, leukemia and other medicines, along with tens of thousands of anticoagulant pills that purported to treat heart attacks and other diseases, and at least 65 people were detained. Distributors not only sold the fakes to private pharmacies but also to public heathcare systems, particularly in Iraq.
FDA Releases Quarterly List of Safety Investigations
Posted: 18 February 2010
The US Food and Drug Administration (FDA) released its quarterly list of drug safety probes to inform the public about early investigations of potential side effects that have been reported. The lists released this week covered issues identified between April 2009 and September 2009. More than two dozen drugs were listed. Investigations are probing reports of hearing loss, hypothermia, neurological disorders and other adverse events that may be connected to marketed medicines. Being on the list "does not mean that FDA has identified a causal relationship between the drug and the listed risk," according to the agency.
EU’s Centralized OTC Switch Faster but Limited
Posted: 12 February 2010
Makers of over-the-counter (OTC) drugs have welcomed Europe’s new centralized procedure for switching prescription drugs to OTC, but the new process also has drawn attention to the problems of existing national processes. National switches comprise the majority of OTC approvals in Europe, and will likely do so until the EU opens restrictions on which drugs can use the new centralized switch process, so most switches must occur via national approval processes, which can take years to complete.
Philippines to Reveal Next Round of Drug Price Cuts
Posted: 12 February 2010
A second round of voluntary price cuts to popular drugs marketed in the Philippines will be announced next week, according to that nation’s health secretary. The government had asked drugmakers to voluntarily reduce prices on a number of their top-selling and most expensive medicines to avoid government-imposed cuts. Price reduction proposals were due to the government by 22 January and the Pharmaceutical and Healthcare Association of the Philippines confirmed that its member companies had complied with the request, but also has called on the government to find a “more sustainable” approach to ensuring Filipinos’ access to medicines and health care.
US Government to Create Horizon Scanning System
Posted: 12 February 2010
The Agency for Health Care Research and Quality (AHRQ) will use some of the $1.1 billion in federal stimulus money set aside for comparative effectiveness research to create a "horizon scanning system" for the agency and has requested bids to create a the system. The goal of the project will be to "provide AHRQ with a systematic process to identify and monitor healthcare technologies that are likely to have a high clinical, system and cost impact in the US." Some are concerned about the federal government monitoring what is in the pipeline and possibly discouraging innovation, but AHRQ’s director has said the intention is not to impede, but rather to encourage development effective innovative healthcare treatments.
EU Proposes Excipient GMPs
Posted: 12 February 2010
The EU’s Committee on the Environment, Public Health and Food Safety has proposed good manufacturing practice (GMP) requirements for excipients as part of an anti-counterfeiting directive. While the European Fine Chemicals Group (EFCG) supports the measure, according to a spokesperson, saying that “patient safety is paramount” and excipient quality is an important aspect of ensuring this, the group has called for a “deeper analysis” of the situation. Some excipients are already appropriately regulated, according to EFCG, and consequently GMP legislation covering all products would be overly broad and burdensome. EFCG proposes singling out only those excipients that are not already covered by existing rules.
EU-India Free Trade Talks Criticized
Posted: 4 February 2010
Free trade talks between the EU and India resumed last week in Mumbai, but critics in India have complained about a lack of transparency and rumored proposed pharmaceutical patent terms. The text of the draft agreement has not been published and some are decrying the lack of consultation with India’s national parliament and state governments. While no details of the draft’s intellectual property protection terms have been made public, sources say EU representatives are calling for India to accept 20-year patent extensions, a five-year increase over current levels, and extensive data exclusivity provisions.
FDA Moves Authority for Radiology Devices to OIVD
Posted: 4 February 2010
The US Food and Drug Administration (FDA) has moved its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in an effort to effect more cohesive policies on diagnostic device review. Issues under the purview of the radiological branch, which oversees diagnostic imaging equipment and other radiation-emitting devices, had been the subject of public disagreements within the Office of Device Evaluation (ODE). OIVD Director Alberto Gutierrez commented that the agency had seen discrepancies emerge between how OIVD was regulating diagnostics compared with other divisions within ODE, but an agency spokesperson stressed that the move was meant to address regulatory concerns, not personal tensions.
Obama Proposes Generic User Fees
Posted: 4 February 2010
The Obama administration is asking Congress to pass legislation allowing the US Food and Drug Administration (FDA) to collect user fees from generic drugmakers, as it does from sponsors of innovator medicines. The money would be used to speed review times and reduce the current backlog of applications, according to the proposed budget documents. Generic drugmakers have been supportive of such user fees as long as they are coupled with improvements in the FDA review process. Some of the money collected could be put toward creating a regulatory approval pathway for biosimilars.
EC Issues Medical Device Report
Posted: 4 February 2010
A report from the European Commission's Exploratory Process on the Future of Medical Devices was published last week identifying challenges facing the medical devices industry. The Exploratory Process was coordinated by DG Enterprise and brought together European medical device stakeholders.
January
DTC Ads More Muted Due to Stricter FDA Enforcement
Posted: 28 January 2010
Direct-to-consumer ads for prescription medicines in the US have grown increasingly serious in tone due to stricter enforcement of regulatory guidelines by the US Food and Drug Administration (FDA), according to industry analysts. Consumers may have noticed, for example, decreasing use of sexual innuendo used in ads for erectile dysfunction treatments, and more attention paid to side effect warnings. When Margaret Hamburg was confirmed FDA commissioner last year, she promised more aggressive enforcement of existing ad guidelines. The agency issued almost double the number of warning letters to drugmakers in 2009, compared with the previous year.
Drug, Device Recalls Up Sharply in UK
Posted: 28 January 2010
The number of product recalls and alerts affecting drugs and medical devices in the UK nearly quadrupled between 2004 and 2008, according to a new study. The report from Blueview Group cites manufacturing errors as the most common reason. Recalls and alerts climbed to 94 from just 22 during the four-year period, with nearly two-thirds attributed to manufacturing defects. The study found 12% of pharmaceutical recalls were caused by labeling and packaging problems and 9% due to compromised sterility.
US Orphan Drug Numbers More Than Doubled
Posted: 28 January 2010
The number of orphan drug designations in the US more than doubled in the last decade, growing from 208 during 2000-02 to 425 in 2006-08, according to a new study. The Orphan Drug Act was passed in 1983 to promote the development of products for rare diseases or conditions affecting fewer than 200,000 people. Since then, more than 2,000 products have been designated as orphan drugs, and the US Food and Drug Administration (FDA) has granted market approval to 350 drugs and biologics, according to the study conducted by the Tufts Center for the Study of Drug Development. The report also found that, during the 2000s, orphan products comprised 22% of all new molecular entities and 31% of all significant biologics receiving US marketing approval.
Electronic Submissions to CDRH on the Rise
Posted: 28 January 2010
Electronic submissions to the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) significantly increased from 2008 to 2009. The number of electronically filed device submissions climbed from 4,619 to 21,296 last year, according to FDA statistics cited in a recent post on a regulatory consulting company’s blog. These numbers provide strong evidence of the acceptance of electronic submissions and suggest they could grow further after a final ruling is issued on the agency’s draft guidance on electronic medical device reporting.
FDA Names Shuren Permanent CDRH Chief
Posted: 21 January 2010
The US Food and Drug Administration (FDA) named Dr. Jeffrey Shuren the permanent director of the agency’s Center for Devices and Radiological Health (CDRH), which has been criticized in recent years from both outside and within FDA itself for a flawed approvals process. Shuren had been serving as the acting head of CDRH since Daniel Schultz resigned as director in August of last year. FDA Commissioner Margaret Hamburg has said she intends to correct the center’s problems and had already begun doing so prior to Shuren’s appointment. According to documents posted on the FDA website, CDRH priorities for 2010 include strengthening product reviews and increasing transparency about decision making.
Smart Pill Technology Could Open New Possibilities
Posted: 21 January 2010
So-called “smart pills” that can transmit patient health data to external receivers may represent a promising new technology for drugmakers and healthcare providers. Such devices could be used to monitor patients’ reactions to various medications or whether they are following the prescribed dosage regimen. Various studies have estimated that one-third to one-half of prescription drugs are not taken as prescribed, costing an estimated $100 billion a year in the US alone. And with healthcare product makers under increasing pressure to demonstrate the effectiveness of treatments in practice as well as in theory, smart pills could provide needed evidence. However, the technology is not without its critics, as some are concerned about protecting the privacy of patients who may use such a device.
New EU Health Chief Calls for Action on Patient Drug Info
Posted: 21 January 2010
The EU’s new, incoming health commissioner intends to push to break the deadlock on last year’s proposal to allow prescription drugmakers to provide drug information directly to patients. John Dalli, the commissioner-designate for Health and Consumer Policy told the European Parliament’s Committee on the Environment, Public Health and Food Safety last week that the current draft directive needs to be reassessed to “bring more patient’s perspective in the proposal,” and that there may need to be a “harder demarcation between industry and advertising,” but also declared his general support for patients’ right to accurate information on prescription medicines.
UK May Allow Early Drug Access; Funding Uncertain
Posted: 21 January 2010
A new proposal in the UK could grant some groups of patients early access to certain new medicines prior to their formal approval. However, the government has no plans in place to provide funding for such drugs. The proposed scheme would allow patients without treatment options to receive drugs in development that could potentially prolong their lives, similar to the US Food and Drug Administration’s Treatment IND regulation, which permits the use of an investigational drug among some patients, provided the drug is for a serious or life-threatening disease and there is at least preliminary evidence of efficacy. Most countries, including the UK, have compassionate use programs permitting patients to obtain investigational drugs on an individual basis, but only a few, including the US, France and Sweden, have programs to allow early access to cohorts of patients.
Philippines Asks Drugmakers for More Price Cuts
Posted: 21 January 2010
After seeking and getting price cuts for a number of essential medicines last summer, the government of The Philippines is asking drugmakers for a second round of price reductions. While pharmaceutical companies are being asked to voluntarily reduce prices on select medicines up to 50%, the government is prepared to impose reductions as it did last summer for five essential medicines. Prices for an additional 16 medicines were lowered voluntarily by drug companies at the time. Drugmakers had been given an initial compliance deadline of 14 January for this round of cuts, which has now been extended to 22 January.
FDA Launches First Phase of Transparency Initiative
Posted: 14 January 2010
This week, the US Food and Drug Administration (FDA) launched its new "FDA Basics" area of the agency's website as the first step in its new transparency initiative. FDA Basics is intended to help the public more fully understand how the agency works and includes information about FDA's organizational structure, regulated products, regulatory processes, answers to frequently asked questions and video interviews with agency personnel. During the next phases of the initiative, FDA plans to focus on making information about agency activities more "transparent, useful, and understandable in a manner that's compatible with our goal of protecting confidential information," said Joshua Sharfstein, principal deputy commissioner of food and drugs.
EU Investigates Pay-for-Delay Deals; Ban Proposed in US
Posted: 14 January 2010
So-called "pay-for-delay" deals to delay competition from generic drugs are being further investigated by the European Commission (EC) while a group of US officials have proposed an explicit ban of the practice. EC antitrust investigators report they have asked unnamed pharmaceutical companies for details of patent settlement deals as part of an ongoing pharmaceutical competition inquiry. At the same time, a group of legislators from the US House of Representatives and the Federal Trade Commission chairman are calling for a provision in the pending healthcare reform legislation that would prevent brand-name drugmakers from directly or indirectly paying generic makers to delay cheaper generic alternatives. The House version of the bill already includes such a ban while the Senate version does not.
EU is Slow to Move on Direct-to-Patient Drug Info
Posted: 14 January 2010
Last year, the EU proposed a package of legislation, including a provision that would allow drugmakers to distribute nonpromotional information about prescription medicines directly to patients, but has yet to act on it. The goal of such a change would be to provide greater access to information on existing medications without legalizing the type of direct-to-consumer advertising that is allowed in the US. However, the EU appears to be moving slowly as the draft proposal is stalled and is likely to be amended, with the soonest action not likely until May of this year.
US Medical Research Funding Down, Say Report
Posted: 14 January 2010
Public and private funding for US biological and medical research has slowed and resources from one major federal source shrank when inflation is taken into account, researchers reported this week. The team from the University of Rochester Medical Center said its findings suggest a more cautious future for medical research, and one in which new scientists may shy away from more innovative and risky projects that could deliver potential breakthroughs, in favor of safer endeavors. According to the report, industry sources invested the most in biomedical research, accounting for 58% of all 2007 spending, and the US National Institutes of Health (NIH) was the second-largest source, accounting for 27%, but NIH funding fell by 2% in real terms.
FDA Drug Approvals Up in '09; NDAs Need Improvement
Posted: 7 January 2010
The US Food and Drug Administration (FDA) approved one more new drug last year than it did the year before—25 in 2009, compared with 24 in 2008. While this is not a big increase, it is the second year in a row of higher approval totals. With Office of New Drugs Director John Jenkins revoking late last year the permission he had previously granted his staff to miss user fee deadlines, innovator drug sponsors are looking forward to favorable new drug review conditions heading into 2010. However, Jenkins recently advised sponsors that they need to submit better applications. Speaking before a group of biopharma executives last month, he told the audience that in his view, too many new drug applications are filed before they are complete to meet sponsors' internal goals.
FDA Developing Tougher Standards for Devices
Posted: 7 January 2010
In the wake of criticism about the way the US Food and Drug Administration (FDA) handles the approval of medical devices, the agency is developing guidelines that will set tougher scientific approval standards. The new standards will set the bar higher for data from tests on humans that device makers must submit when seeking approval. FDA's acting director of the Center for Devices and Radiological Health told The New York Times that the agency most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, he added.
Drugmakers Accused of Promoting "False Pandemic"
Posted: 7 January 2010
The Parliamentary Assembly of the Council of Europe plans to convene this month for an emergency debate and inquiry into alleged influence exerted by drugmakers on the World Health Organization's (WHO) global H1N1 flu campaign. Critics charge that drugmakers influenced WHO scientists, encouraging a "false pandemic" in an effort to promote unnecessary flu drug and vaccine sales. In France, President Nicolas Sarkozy, is at the center of a political controversy after health authorities admitted they had a huge oversupply of vaccines for the H1N1 virus and were trying to sell them to other countries. Pharmaceutical manufacturers face the prospect of significantly lower flu vaccine sales than forecast as a growing number of governments seek to renegotiate purchases of unused stocks.
UK Clinical Trials Decline Sharply in 2009
Posted: 7 January 2010
The latest figures from the UK's Department of Health show a sharp decline in the number of clinical trials conducted in that country. The number of mid- and late-stage and postapproval clinical trials fell from 728 in 2008 to 470 in 2009, the lowest of the past decade. Early-stage trials fell to 210, the lowest in five years. Despite government efforts to encourage UK-based trials, bureaucracy, low recruitment rates and the slow uptake of new drugs are being blamed for pharmaceutical companies' moves to conduct more research in other countries in Europe and North America, as well as increasingly in low-cost, developing nations. The UK's share of global clinical trials fell from 6% in 2002 to 2% in 2007.
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