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Latest News: 2009

December 2009

  • FDA's Drug Review Staff Relatively Inexperienced

    Posted: 17 December 2009

    The US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) has bolstered its employee roster over the last two years, but as a result, now has a relatively under-experienced staff. About 38% of employees in both CDER and its Office of New Drugs have less than two years of on-the-job experience. FDA has been severely understaffed so the added personnel are certainly helpful, but CDER also depends heavily on institutional knowledge and the expertise of its review teams to approve and regulate new drugs and biologics. Read the article »

  • Drugmakers Concerned Over EU's New Pharma Structure

    Posted: 17 December 2009

    While the move to shift the EU's pharmaceutical policy responsibility to the European Commission's (EC's) Health directorate has been viewed largely as a positive, drugmakers are expressing concern. Some in the pharmaceutical industry are worried the change may mean decreased emphasis on pharma's contribution to trade, innovation and job creation, and more focus its role as a healthcare provider. Previously pharma policy fell under the purview of the EC's Enterprise and Industry directorate. Read the article »

  • FDA Opens Office in Mexico City

    Posted: 17 December 2009

    The US Food and Drug Administration (FDA) has announced the opening of a new office in Mexico City. The new post is intended to provide increased support for ensuring the safely of medical products and food entering the US market from Mexico. FDA officials there will work closely with their Mexican counterparts. FDA says the Mexico City office is its third post in Latin America and its 10th international office opened during the past 13 months. Read the article »

  • Patent Pool to Help Poor Countries Get AIDS Drugs

    Posted: 17 December 2009

    The drug purchasing group Unitaid is moving ahead with an innovative plan for increasing access to AIDS drugs for patients in developing countries. The group is seeking to create a patent pool, whereby drug manufacturers such as Gilead Sciences, Abbott Laboratories and GlaxoSmithKline give a limited number of generic drugmakers access to their AIDS drug patents in exchange for a small royalty. The generic companies then sell generic versions at dramatically reduced costs in low-income countries.Read the article »

  • US Senate to Vote on Reimportation; FDA is Opposed

    Posted: 10 December 2009

    In the US Senate, a bipartisan group of legislators is pushing for an amendment to allow US pharmacies and drug wholesalers to import approved drugs from Canada, Europe and a few other countries and a vote is expected soon. The US Food and Drug Administration (FDA) has come out against the prospect. FDA Commissioner Margaret Hamburg raised concerns in a letter to Sen. Sam Brownback (R-Kan.) that "as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns." As recently as yesterday, it was reported that President Barack Obama still supports reimportation, something he talked about during his campaign. Read the article »

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  • Jenkins: FDA to Return to Meeting User Fee Deadlines

    Posted: 10 December 2009

    After a nearly two-year break from strict adherence to the review timeframes set forth in thePrescription Drugs User Fee Act, US Food and Drug Administration (FDA) Office of New Drugs Director John Jenkins says he has instructed his staff to resume meeting the user fee deadlines. Jenkins disclosed this during remarks last week at a pharmaceutical industry summit. He also lamented the low rate of first-cycle approvals for standard applications and wondered if publicly releasing the complete response letter would spur sponsors to submit applications that were truly ready and might have a better chance of getting a first-cycle approval. Read the article »

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  • EU Raids Drugmakers' Offices in Antitrust Investigation

    Posted: 10 December 2009

    EU antitrust regulators made surprise raids on the offices of drugmakers in several European nations this week, seeking evidence that they struck anticompetitive "pay for delay" deals to keep generics off the market. EU investigators have been looking into anticompetitive practices in the pharmaceutical sector and companies that may be deliberately stalling cheaper generic versions of their own medicines once exclusive patents expire. Read the article »

  • EMEA Unveils New Identity and Structure

    Posted: 10 December 2009

    The European Medicines Agency officially unveiled its new identity and organizational changes this week. Though the agency has been known as the European Medicines Agency for some time, it has now officially abandoned usage of the obsolete EMEA acronym, a holdover from the agency's original name, the European Medicines Evaluation Agency. The agency also has a new visual brand identity. Among the highlights of the new organizational structure is the integration of human pre- and postauthorization activities into one unit, intended to unify oversight of medicines over the entire product lifecycle. Read the article »

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  • Europe's Health Commissioner Will Oversee Pharma Policy

    Posted: 3 December 2009

    In a surprising move, pharmaceutical policy in the new European Commission will no longer be the responsibility of DG Enterprise and Industry but will shift to the Health and Consumer Policy directorate, DG Sanco. Responsibility for the European Medicines Agency (formerly EMEA) will be among the responsibilities of new Health Commissioner-designate, who will also take control of biotechnology. The change is being welcomed by consumer advocacy groups and nongovernmental organizations, which have long pointed out that health ministries and departments are responsible for pharmaceuticals in most EU Member States. Read the article »

  • US Vaccine Makers Struggle to Modernize

    Posted: 3 December 2009

    US manufacturers are still struggling to modernize and speed vaccine production despite more than five years of efforts to do so and about $2 billion in government spending. The system is hampered by a dearth of manufacturing plants and decades-old technology that takes six to nine months to make flu vaccine and involves growing the virus in chicken eggs. Read the article »

  • Funding Crisis Could Force Euro Drugmakers to Drop R&D

    Posted: 3 December 2009

    European biopharmaceutical companies' existing problems in gaining access to funding have been worsened by the global financial crisis. Eventually, this could force companies to give up their drug development activities, warns a new report. Drugmakers abandoning R&D would have serious implications for innovation, economic growth and employment in Europe, says the study, a joint project by the European Commission's Directorate General for Enterprise and Industry and the Danish Technological Institute. Read the article »

  • Consumers Ignore Risk Info in TV, Print Ads

    Posted: 3 December 2009

    Consumers, particularly those over age 55, tend to block out risk information presented in television and print ads for prescription medicines, according to a new study. Research firm ORC Guideline found that 41% of US consumers pay little or no attention to risk information in such TV advertisements and half did the same for disclosures in print ads. Respondents over the age of 55 were especially likely to tune out risk information. ORC Guideline's chief of research attributed the lack of attention to information overload. Read the article »

November 2009

  • FDA Holds Social Media Hearing, Next Steps Unclear

    Posted: 19 November 2009

    The US Food and Drug Administration (FDA) held its highly anticipated public hearing on Internet and social media promotion last week, but how the agency will proceed remains unclear. Over the course of two days, stakeholders from healthcare product manufacturers, patient advocate groups and new media companies took turns giving short presentations and taking questions during what one presenter called "the Super Bowl of Part 15 hearings." However, FDA's next steps are still very much in question. To this point, FDA has not addressed the unique issues presented by social media head on, leading most companies to take a fairly cautious approach. There is currently no formal policy on the subject and no timeline for establishing one. For more on how drugmakers are engaging in social media, see the article on the topic in the November 2009 issue of Regulatory FocusRead the article »

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  • EU Clinical Trial Regs Impede Research, Say Academics

    Posted: 19 November 2009

    EU clinical trial guidelines put in place to make trials safer and more efficient are actually slowing down studies that could help patients, says a group of Scottish academics writing in the journal PLoS Medicine. EU's Clinical Trials Directive strongly suggests trials evaluating investigational medicinal products follow Good Clinical Practice (GCP) and while the directive is not legally binding in most EU countries, it is enforced by many academic institutions and regulatory agencies. The researchers contend that the stringent definition of GCP in the directive makes sense for trials sponsored by biopharma companies developing new medicines, but not for trials run by academic medical centers studying existing drugs to fine-tune their use in clinical settings. Read the article »

  • US Bills Could Affect Liability Risk for Device Companies

    Posted: 19 November 2009

    While much of the US medical device community's attention has been focused on the current healthcare reform debate and the fees government is seeking to impose, there are two other, related bills looming in the US House and Senate that would increase product liability risk for medical technology companies. The two bills address safety for patients who use medical devices and their legal recourse if the products cause any harm. With the healthcare overhaul front and center, action on these bills is not likely before next year, but advocates and critics of the bills say the issue will keep coming back until it's resolved. Read the article »

  • Drugmakers Won't Benefit From Healthcare Reform Until 2015 

    Posted: 19 November 2009

    Pharmaceutical industry leaders seem to be cautiously optimistic about the bottom line impact of US healthcare reform efforts, which will extend health insurance to up to 39 million additional people. However, they do not expect major changes any time soon, and do not expect to reap any benefits until after 2015. At a summit meeting last week in New York, one top pharma executive told the attendees he expected "a drag on the top-line for a couple of years... and then the volume impact is going to come three years and onward." One healthcare market researcher presented a forecast predicting the major impact of reform will commence between 2015 and 2020. Read the article »

  • EU Drugmakers Agree to Have Drug Info Vetted

    Posted: 12 November 2009

    European drugmakers have agreed to allow information on their medicines to be vetted by an independent authority before being made available to the public. The move could break the deadlock on the European Commission's proposal that would allow the pharmaceutical industry to communicate directly to consumers. The controversial plan has been stalled since health ministers of many EU countries expressed strong opposition at a meeting in early June. Drugmakers' willingness to accept the approval procedure was expressed this week at a European Parliament event by Arthur Higgins, president of the European Federation of Pharmaceutical Industries and Associations. Read the article »

  • FDA Commissioner Reassures Docs on H1N1 Vaccine

    Posted: 12 November 2009

    This week, US Food and Drug Administration Commissioner Dr. Margaret Hamburg took the unusual step of writing a letter to all US healthcare professionals in an effort to reassure them and the public about the safety of the H1N1 flu vaccine. The letter reiterates what FDA and other public health agencies have been saying for months––that the vaccine is made exactly the same way as the seasonal flu vaccine and that there is no reason to believe it is any less safe. Hamburg's letter comes after some outspoken skeptics have questioned the vaccine's safety. Read the article »

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  • Universities to Promote Global Access to Drugs for Poor

    Posted: 12 November 2009

    Harvard and Yale are among six universities pledging to encourage companies to give poor countries better access to drugs and medical products stemming from discoveries made on their campuses. Along with Brown University, the University of Pennsylvania, Oregon Health and Science University and Boston University, they released a statement this week intended to guide how drugs developed by researchers at the schools are licensed to companies. The statement commits the schools to make "vigorous efforts" to promote global access to drugs through licensing strategies. Read the article »

  • ICH Makes Progress on Guidelines and Training

    Posted: 12 November 2009

    Representatives of the International Conference on Harmonisation (ICH) report that the group made progress on several guidelines and training programs it has developed in its efforts to promote international harmonized standards. ICH's S9 guideline is designed to expedite the development of treatments for patients with advanced cancers while maintaining safety regulations and ICH S6 covers "Revision of preclinical safety evaluation of biotechnology-derived pharmaceuticals." ICH also moved ahead with efforts to develop a training program for workshops on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10). Read the article »

  • Japanese Drugmakers Look to Foreign Markets

    Posted: 5 November 2009

    Government cost-containment measures and increased competition from foreign companies have pushed Japanese drugmakers to more aggressively pursue markets abroad. Traditionally, generics have not had a big market in Japan, but with an aging population, the Japanese government has been promoting the less expensive alternatives to brand-name medications and drugmakers' profits have been squeezed. Recently, mergers have also given foreign manufacturers a foot in the door of Japan's notoriously difficult market for outsiders, but Japanese companies have made some inroads into markets like the US and EU, as well. Read the article »

  • Obama Administration Supports Investors in Vioxx Case

    Posted: 5 November 2009

    The Obama administration has filed a friend-of-the court brief supporting Merck investors who charge in a US Supreme Court case that the drugmaker misrepresented the safety of its Vioxx painkiller. Merck has argued that investors should have filed their lawsuits earlier as there was plenty of public information available by late 2001 regarding the possibility that the company had made misstatements about the drug's safety. The brief filed by US Solicitor General Elena Kagan supports investors' contention that the lawsuits were not filed too late. Read the article »

  • FDA Announces Safe Use Initiative

    Posted: 5 November 2009

    The US Food and Drug Administration (FDA) announced its Safe Use Initiative this week to propel a coordinated effort was across the US healthcare system to reduce unnecessary complications from drug misuse, dosing errors, drug interactions or abuse. FDA's plan includes collaboration with healthcare professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm and develop cross-sector interventions for reducing harm from problems associated with them.Read the article »

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  • Millions Die Because Malaria Drugs Too Expensive

    Posted: 5 November 2009

    Nearly a million people die each year from malaria because they cannot afford the most effective treatment, instead buying old drugs to which the malaria parasite has become resistant, according to researchers. Artemisinin combination therapy, or ACT, drugs can cost as much as 65 times the daily minimum wage in some African countries, but experts hope a new $225 million affordable medicines subsidy program will drastically cut the price of ACTs in poorer nations. Read the article »

October 2009

  • Enforcement is the Word at FDA

    Posted: 29 October 2009

    Top officials at the US Food and Drug Administration (FDA) continue to emphasize the agency's enforcement message and, as FDA Commissioner Margaret Hamburg told attendees at the 2009 RAPS Annual Conference, "show both industry and consumers that it is on the job." While Commissioner Hamburg delivered the big picture message, other FDA leaders revealed details of stepped-up timelines, increased support for innovative science and product type-specific issues at the RAPS conference and other, industry meetings. Read the article »

  • EMEA Concerned About Fake H1N1 Medicines

    Posted: 29 October 2009

    The European Medicines Agency (EMEA) is warning the public that criminals are trying to cash in on H1N1, "swine flu" fears by selling counterfeit medicines and vaccines online. European authorities have become increasingly concerned as more fake or very low-quality H1N1 treatments are appearing for sale through various websites. The warning comes as the European Parliament prepares to debate new rules covering counterfeit medicines. Read the article »

  • GAO Report: FDA Far Behind on Postmarket Studies

    Posted: 29 October 2009

    More than a third of the postmarketing studies required by the US Food and Drug Administration's (FDA) fast-track approval process have not been completed as long as 13 years later. The process, intended to help speed drugs for serious and life-threatening conditions to market, also requires drugmakers to conduct safety and effectiveness studies on their products after approval, which is based on surrogate endpoints as substitutes for clinical endpoints. Ninety such applications were approved between 1992 and 2008 but by December of last year, only 64% of the required studies had been completed. Read the article »

  • Comparative Effectiveness Could Imperil Personalized Med

    Posted: 29 October 2009

    The US government's initiative to control healthcare costs partly by using comparative effectiveness research could run counter to advances in personalized medicine, said Dr. Francis Collins, director of the National Institutes of Health. Personalized medicine uses medical approaches tailored to an individual's genetic makeup. Dr. Collins stressed the need to factor genetic information into any research on effectiveness. Read the article »

  • Proposed Biosimilar Pathway Useless, Say Critics

    Posted: 22 October 2009

    Legislation approved by US House and Senate committees to establish a regulatory pathway for biosimilar medicines would scarcely be used, say critics writing in the New England Journal of Medicine. The proposed plan would guarantee manufacturers 12 years of market exclusivity for a new biologic before any generic versions could be approved and companies could also obtain an additional 12 years by making minor changes to their approved product. While supporters of a long exclusivity period argue that it is necessary for manufacturers to recoup costs and spur innovation, others charge the pending legislation ignores the unique attributes of biologic medicines and does not do enough to protect patient interests.Read the article »

  • FDA Slow to Ban Unethical Researchers, Says GAO Report

    Posted: 22 October 2009

    A report from the US Government Accountability Office (GAO) this week charges that the US Food and Drug Administration (FDA) pays little attention to its responsibilities to ban investigators convicted of fraud, taking an average of four years to do so. In a review of 18 proceedings, investigators for the found that FDA took from one to 11 years to ban such unethical researchers, allowing many who were convicted of fraud to remain eligible to conduct experiments for years. FDA released a statement saying it had improved the process with increased staffing and centralized coordination. Read the article »

  • Drugmakers Support Sending Generics to Rwanda

    Posted: 22 October 2009

    Three pharmaceutical companies voiced support for continued efforts by a Canadian generic drugmaker to distribute cheaper versions of their patented HIV/AIDS medicines in Rwanda. GlaxoSmithKline and the Canadian subsidiaries of Shire and Boehringer Ingelheim authorized Canadian generic drug maker Apotex to export the medicines to developing nations under Canada's Access to Medicines Regime (CAMR). In 2004, Canada became the first industrialized country to modify its drug patent legislation to permit the export of generic drugs to developing nations in need. However, Apotex representatives say the CAMR rules are so cumbersome that so far, Rwanda has been the only eligible nation willing and able to take advantage of the program. Read the article »

  • Dartmouth Docs Say Drug Labels Lack Key Info

    Posted: 22 October 2009

    Writing in the New England Journal of Medicine, two physicians from the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, NH, charge that US Food and Drug Administration (FDA) approved drug labeling often lacks critical information. Dr. Lisa Schwartz and Dr. Steven Woloshin wrote that much of the important information FDA has access to when the agency approves a product fails to make it into the drug label and related journal articles. They point out that while $1.1 billion has been allocated for comparative effectiveness research, relatively little attention has been paid to disseminating existing but "practically inaccessible" drug risk/benefit information. Read the article »

  • New Conflict Disclosure Standards for Medical Journals

    Posted: 15 October 2009

    The International Committee of Medical Journal Editors has introduced a new disclosure form and is encouraging all medical journals to follow its comprehensive, standardized rules for revealing potential conflicts of interest. So far, at least a dozen publications have agreed to use a new, standardized disclosure form intended to address recent criticism about undisclosed conflicts. The new standards go beyond many journals' current rules and include items such as financial relationships involving spouses, partners or minor children as well as nonfinancial conflicts, such as religious and political affiliations.Read the article »

  • UK Thalidomide Victims Seek Compensation

    Posted: 15 October 2009

    Hundreds of people in the UK who suffered birth defects caused by the morning sickness drug, thalidomide, are demanding government compensation half a century after UK authorities approved the drug. Thalidomide's UK importer created a £20 million trust fund in 1973 to compensate victims, but the government has never provided any financial compensation or publicly taken responsibility the drug's approval. Activists contend that questions about thalidomide's safety and warnings from the World Health Organization should have led UK regulators to ban the drug as the US Food and Drug Administration had.Read the article »

  • USPTO Drops Contested Patent Rules

    Posted: 15 October 2009

    The US Patent and Trademark Office (USPTO) has agreed to drop four controversial patent regulations opposed by pharmaceutical companies including GlaxoSmithKline (GSK). The rules, originally proposed by the George W. Bush Administration, would have forced drugmakers to pare down the size of their patent applications in order to streamline USPTO's processes and help manage the agency's backlog of unexamined applications. However, the rules were repealed by current USPTO Director David Kappos who commented that they were "highly unpopular" with applicants. GSK had been fighting the regulations in court, arguing they would have hampered pharmaceutical innovation. Read the article »

  • Report Says FDA Internet Rules Deprive Consumers of Info

    Posted: 15 October 2009

    A report released last week by the Competitive Enterprise Institute (CEI) says the US Food and Drug Administration's (FDA) restrictive approach to sponsored Internet links could deprive consumers of valid, regulated information. The report argues that FDA is actually helping make more trustworthy information less available online while making more dubious and unsubstantiated information more prominent and that the agency must treat Internet-based promotion differently than other forms of media. Critics argue that CEI offers little evidence to support the contention that there is a lack of regulated information online, however, many have been calling for FDA to modernize its approach to oversight of online communications. FDA will hold a public hearing on Internet promotion of regulated products 12–13 November. (Note: Internet and social media promotion will be the topic of an article in the November issue of RAPS' Regulatory Focus magazine.) Read the article »

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  • EC Raids Offices of Drugmakers Suspected of Collusion

    Posted: 8 October 2009

    The European Commission has begun a series of surprise inspections of the offices of European drugmakers suspected of anti-competitive behavior. While EC officials have not identified any of the companies, they say they have reason to believe the targeted drugmakers are illegally delaying the launch of generic competitors by making secret "pay-for-delay" deals with generic manufacturers. This practice is estimated to cost European healthcare systems billions of Euros. Read the article »

  • Drugmaker Sues for Right to Discuss Off-label Uses

    Posted: 8 October 2009

    Allergan, the maker of Botox, has challenged the US Food and Drug Administration's (FDA) prohibition against marketing to physicians regarding off-label uses of approved drugs. The company filed a lawsuit last week arguing it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. FDA recently required Allergan to initiate a Risk Evaluation and Mitigation Strategy (REMS) program for Botox to help prescribing doctors better evaluate the risks and benefits of treatment. In addition to its popular use as a wrinkle treatment, Botox is FDA-approved for eye muscle disorders and excessive underarm sweating and is also frequently prescribed for off-label uses, including treatment of muscle-spasm conditions. Read the article »

  • FDA Plans to Improve Risk Communication

    Posted: 8 October 2009

    The US Food and Drug Administration (FDA) last week issued its Strategic Plan for Risk Communication, which lays out how the agency plans to disseminate more meaningful public health information about FDA-regulated products. According to the plan, over the next 12 months, the agency will begin to survey the general public on their understanding of, and satisfaction with, FDA communications. Agency officials are concerned the public "may not understand the context within which FDA makes decisions about recalls of particular foods or medical products," and hopes to improve public understanding of the approval and recall process, as well as the concepts of risk and benefit of regulated products. Read the article »

  • Use of eCTD Not Yet Global

    Posted: 8 October 2009

    The electronic Common Technical Document (eCTD) has established a useful common format for regulatory submissions for those countries that have adopted it. While it has helped ease the submission process for sponsors seeking approval in the US, UK, Japan and Canada, it is not yet a truly global standard, There are many authorities, particularly in emerging markets, that are much more responsive to their domestic submission format, even while accepting the eCTD. Some challenges to universal adoption of the standard include lack of technical infrastructure, the existence of proprietary electronic submission formats and the usage of the CTD but not the eCTD by certain countries. Read the article »

  • FDA Proposes New CGMP Rule for Combo Products

    Posted: 1 October 2009

    The US Food and Drug Administration (FDA) has proposed a rule to clarify the current Good Manufacturing Practice (CGMP) requirements for combination products. The existing FDA guidance covers CGMP requirements for the individual parts of combination products, such as drugs, biologics and devices. The proposed rule is meant to set forth "a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for 'single-entity' and 'co-packaged' combination products," according to the notice of the proposed rule in the Federal RegisterRead the article »

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  • FDA Extends Quality-by-Design Pilot

    Posted: 1 October 2009

    The US Food and Drug Administration (FDA) announced it has extended the deadline for groups wishing to take part in its quality-by-design (QbD) pilot program. The QbD concept was laid out by the International Conference on Harmonisation (ICH) in its most recent quality documents and is intended to foster new ways to build quality into products from the earliest stages of development. FDA Commissioner Margaret Hamburg touched on QbD at the recent 2009 RAPS Annual Conference & Exhibition, telling attendees "Companies need to understand from the start what makes a quality product, rather than determining that through testing after the fact." Read the article »

  • Vaccines Give Drugmakers a Boost

    Posted: 1 October 2009

    After years of retreating from vaccines production, many of the world's biggest pharmaceutical companies are back in the vaccine arena. Some companies had deemed vaccines not worth their time due to low profits and the threat of lawsuits However, the worldwide demand for a vaccine to combat the H1N1, "swine flu" pandemic, along with the dearth of new drugs in late-stage development has caused drugmakers to reconsider, and a number of recent deals point to the business of making vaccines being hot again. Read the article »

  • In EU, Concern Over Variations Regulations Reqs.

    Posted: 1 October 2009

    In response to two new draft guidances on new variations regulations, representatives of the EU pharmaceutical industry and Competent Authorities have raised concerns that reporting requirements may be too burdensome. They say the requirements create a heavy workload related to minor manufacturing changes, and urged the European Commission to exempt these changes from the annual reporting requirements. There were also complaints that pre-notification requirements on upcoming manufacturing changes are unworkable. Read the article »

September 2009

  • FDA to Hold Public Hearing on Web, Social Media Promo

    Posted: 24 September 2009

    The US Food and Drug Administration (FDA) will hold a two-day public hearing on how companies use the Internet and social media to advertise and promote regulated products. According to its posting in the Federal Register, FDA is seeking input from consumers, patients, caregivers, healthcare professionals, patient groups, Internet vendors, advertising agencies, representatives of regulated industries and other interested parties. Some FDA observers have been calling for more specific direction from the agency on how companies are allowed to communicate about healthcare products online. Some companies have been frustrated with what has been perceived as inconsistent enforcement actions while industry critics say drugmakers and others have exploited the lack of FDA guidance. The public hearing will be held 12–13 November in Washington, DC. Read the article »

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  • Drugmaker Sues FDA to Stop Sale of Nonequivalent Generic

    Posted: 24 September 2009

    Drugmaker Wyeth this week filed suit against the US Food and Drug Administration (FDA) to block the sale of a generic version of its antibiotic Zosyn, saying the generic is not an equivalent product and could harm critically ill patients. The company is seeking a temporary restraining order and a preliminary or permanent injunction and asks the court to force FDA to withdraw its approval of a generic version of the drug by India's Orchid Chemicals & Pharmaceuticals Ltd. Wyeth says that the generic is based on a previous version of Zosyn that was discontinued in 2005 and having two versions on the market will cause confusion. Lawsuits by major drugmakers against the FDA are relatively rare as companies are hesitant to take such legal action, knowing they will be seeking FDA approval for future products. However, Wyeth seems to have a strong scientific argument in the case and is in a unique position since the company will soon be absorbed by Pfizer. Read the article »

  • Japanese Regulators Seek to Cut Device Approval Time

    Posted: 24 September 2009

    Medical device manufacturers have long criticized the Japanese regulatory process as particularly difficult and slow, but Japanese officials are moving to significantly cut the time that process takes. Late last year, Japan's Ministry of Health, Labor, and Welfare (MHLW) released a five-year plan to streamline the medical device regulatory process. The plan is funded by increased user fees and will triple the number of medical device reviewers. MHLW aims for a median approval time of 14 months for regular new medical devices and 10 months for specially designated fast-track new devices. Read the article »

  • News From RAPS Annual Conference & Exhibition

    Posted: 24 September 2009

    If you were unable to attend the 2009 RAPS Annual Conference & Exhibition last week in Philadelphia, you can see video of FDA Commissioner Margaret Hamburg's closing keynote speech and read some of the coverage generated by the conference. Dr. Hamburg stressed the importance of a continuing partnership between FDA and RAPS and its members, and emphasized the need to support the discipline of regulatory science. Read coverage of the Commissioner's remarks and other news from the conference on RAPS.org.

  • FDA Chief Addresses RAPS Conference

    Posted: 17 September 2009

    US Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg spoke to attendees of the 2009 RAPS Annual Conference & Exhibition yesterday, stressing the importance of a continuing partnership between FDA and RAPS and its members. Hamburg emphasized the need to support the discipline of regulatory science in government and regulated industry in order to quickly and effectively translate biomedical breakthroughs into real products that benefit the public. She also reiterated her commitment to restoring public confidence in FDA and to "effective enforcement" of the agency's regulations. Read the article »

  • EMEA Concerned About Cost Watchdogs

    Posted: 17 September 2009

    The head of the European Medicines Agency (EMEA) expressed concern recently that Europe's various cost-effectiveness watchdog agencies may be treading a little too close to EMEA's territory when it comes to offering scientific advice. Governments and other payers are increasingly requiring more health technology assessment (HTA) and cost-effectiveness information before paying for treatments. The problem, according to EMEA Executive Director Thomas Lonngren, is that some HTA agencies give scientific advice, "and so do we. And we'll have a big problem in drug development if there's too much different scientific advice going around." Read the article »

  • Astronomical Technology Used to Detect Counterfeit Drugs

    Posted: 17 September 2009

    Researchers in the UK have developed a system that uses technology originally designed for astronomical research to detect counterfeit drugs that they say is cheap, quick and requires no special action by manufacturers. The system relies on a spectrograph to detect differences in the characteristics of light reflected from printed packaging. A unique light source is shone on the packaging and the reflection is measured and validated against the manufacturers' original packaging. In order for a counterfeit product to trick the system, the colors on every part of the packaging would have to be an exact match to the original, which the researchers say would be extremely difficult to accomplish. Read the article »

  • Editor Uses Forensics to Uncover Medical Ghostwriting

    Posted: 17 September 2009

    In an effort to uncover ghostwriters who make significant, uncredited contributions to medical research papers, one editor is using data forensics to find out when documents have been altered by someone other than the identified authors. Frederic Curtiss, editor-in-chief of the Journal of Managed Care Pharmacy, stresses that knowing who worked on published research papers is "critical for a reader to interpret the research." While the practice of ghostwriting is not uncommon, it is considered by many to be unethical, particularly when an unidentified contributor is employed by a company that may stand to benefit from publication. A recent survey found that 12% of research articles in top medical journal studies failed to disclose such contributors. Read the article »

  • Most Drugmakers Meeting FDA Postmarketing Timelines

    Posted: 10 September 2009

    The majority of companies that gain approval for pharmaceuticals and biologics from the US Food and Drug Administration (FDA) are meeting their postmarketing regulatory obligations and completing studies on time. According to a report recently completed by Booz Allen Hamilton and released by FDA, more than 80% of the more than 1,500 open postmarketing studies are proceeding within established timelines or have been determined by FDA to have met their goals. While the report found most drugmakers were completing their obligations on time, it did recommend changes to help improve the quality of the information submitted, timeliness of FDA review and the accuracy of FDA's databases. Read the article »

  • FDA Says US and Europe Comparable on Drug Approvals

    Posted: 10 September 2009

    The US is the largest market in the world for pharmaceuticals but it is no longer the fastest growing and some say it is showing signs of lagging behind Europe in market entry. Recent public remarks to that effect by a high-level regulatory affairs executive of a major drugmaker prompted FDA's top new drug review manager, John Jenkins, to respond to this perception. Jenkins commented that people have expressed concern about whether "FDA is becoming more conservative," and said, "the most recent data we have is from fiscal 2008, and you really can't see any kind of fall-off or change that is dramatic for first cycle approvals of new molecular entities." Jenkins noted that he presented an analysis of recent drug approvals last year and that data showed seven drugs approved in Europe at that time, but not in the US, and only two in the US but not Europe. Read the article »

  • UK Closer to Regulating Home Genetic Tests

    Posted: 10 September 2009

    The UK government's adviser on genetics will call for tough new standards regarding sales of genetic tests to the public. The recommendations, developed with input from companies and academics, would be voluntary but represent a step toward regulating the quickly growing self-test industry. A number of companies providing such tests sold over the Internet have emerged during the past decade and critics are concerned about exaggerated claims for the reliability of genetic testing and say the tests can create unnecessary anxiety. Some have called for an outright ban. Read the article »

  • European Coalition to Hold CT Co-sponsorship Workshop

    Posted: 10 September 2009

    A group of European academic and nonprofit organizations concerned with the clinical trials environment in Europe after the implementation of the Clinical Trials Directive will hold a workshop entitled, Innovative Approaches to Clinical Trials Co-Sponsorship in the EU. This event will bring together representatives of these organizations and other stakeholders to explore the challenges of the single sponsorship requirement under the directive and to consider more research-friendly sponsorship possibilities and innovative ways to collaborate. The workshop is intended to produce recommendations for co-sponsorship provisions in future legislation. It will be held at Hammersmith Hospital in London on 21 September 2009. Read the article »

  • FDA Proposes Mandatory Electronic Device Reporting

    Posted: 2 September 2009

    A new rule proposed by the US Food and Drug Administration (FDA) would require medical device manufacturers to submit medical device reports (MDRs) electronically. Submitting MDRs in electronic format is currently optional and FDA officials say the agency receives 85% of the 300,000 MDRs it gets annually in paper format. The proposed rule would compel device manufacturers and users to report device-related adverse events in the electronic format, which would increase efficiency and eliminate transcription errors associated with receiving paper reports. Read the article »

  • Safety Concerns Delay Generic Substitution in UK

    Posted: 2 September 2009

    In the UK, a new policy that would allow pharmacists to substitute doctors' prescriptions for brand-name medicines with generic equivalents has been delayed due to concerns about safety. The policy is intended to save the National Health Service money by switching many patients from more expensive drugs to cheaper generic versions. However, the plans have been delayed after groups including patient advocate organizations and trade associations expressed concerns that generic drugs are not always identical to the original. Read the article »

  • Biopharma Investing in R&D Despite Down Economy

    Posted: 2 September 2009

    Of the 25 major US corporations identified in a report last week to have increased their R&D spending significantly this year despite the economic downturn, 13 were in the biotech and pharmaceutical sectors. Companies in other areas are taking a more cautious approach. Biotech and pharma companies, on the other hand, must increase R&D in order to replenish the drug development pipeline to try to replace the billions of dollars worth of products set to go off-patent in the next few years.Read the article »

  • Pharma Poised for Growth in Eastern Europe, Latin America

    Posted: 2 September 2009

    Separate reports out this week are forecasting substantial growth for the pharmaceutical markets in Eastern Europe and Latin America. Eastern Europe's market for pharmaceuticals is predicted to grow more than 10% and reach more than $41 billion by 2014, according to a report from Business Insights. Another report from Espicom holds that the eight top pharma markets in Latin America will grow by an average of 9.9% per year during the same time period, making them worth a combined $80 billion by 2014. Read the article »

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August 2009

  • Device Maker: Judges Should Decide Patent Cases

    Posted: 27 August 2009

    In a case that has broad implications for medical device patents, a device maker accused of patent infringement has asked the US Supreme Court to consider granting power over such cases to judges rather than juries. The device company, Medela, was found by a jury to have infringed on two patents relating to wound treatment devices. The company contends these patents should be invalidated on the grounds of obviousness, the standard courts use to determine whether something is innovative enough to merit patent protection, but on which juries are given only brief instruction. Read the article »

  • European Pharma More Innovative Than US, Says Study

    Posted: 27 August 2009

    A new study that reexamines data on the number of first-in-class medicines brought to market by US, European and Japanese drugmakers, contends that European companies have been most innovative. While US pharmaceutical and biotech companies did produce more of such drugs between 1982 and 2003, the new study also takes into account the resources devoted to research and development. By that standard, the Europeans were more innovative than their US counterparts while the Japanese were the most productive. The research was funded by a Netherlands-based partnership of academic organizations and industry partners. Read the article »

  • FDA to Keep Conflicts of Interest Confidential

    Posted: 27 August 2009

    The US Food and Drug Administration (FDA) will, in most cases, not disclose information the agency receives from clinical trial sponsors on its investigators' financial conflicts of interest. According to an official FDA statement "Information such as a proprietary interest in the tested product is already public information and, therefore, releasable. Otherwise, FDA will consider disclosed information as confidential and will consider release of such information only in circumstances in which questions of propriety clearly outweigh the privacy interest. FDA believes that such cases will involve only a small subset of those clinical investigators." Read the article »

  • FDA to Allow H1N1 Flu Test for US Troops Abroad

    Posted: 27 August 2009

    The US Food and Drug Administration (FDA) announced this week it has authorized the emergency use of an H1N1 flu test for US troops overseas. This will allow the military to speed up diagnoses and treatment of the virus in preparation for possible widespread outbreaks during the fall flu season. The Defense Department will distribute the flu tests to its qualified laboratories and will use it for combat units in the Middle East and on Navy ships, beginning next month. An H1N1 vaccine is not expected to be available until at least October. Read the article »

  • FDA Launches Tobacco Center, VA Health Chief to Lead

    Posted: 20 August 2009

    The US Food and Drug Administration (FDA) this week officially launched its new Center for Tobacco Products. The new center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act. The new law was passed in June and gives FDA oversight responsibilities for tobacco including setting performance standards, reviewing premarket applications for new and modified-risk tobacco products, and establishing and enforcing advertising and promotion regulations. FDA named former Veterans Affairs Department chief public health officer Lawrence Deyton as the Center's first director. Read the article »

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  • Philippines Establishes New Regulatory Agency

    Posted: 20 August 2009

    The newly established Philippine Food and Drug Administration this week replaces the Bureau of Food and Drugs (BFAD) as the country's regulatory agency overseeing drug and food safety. The foundation of the new agency is said to have been modeled on the US FDA. According to an official press release, the new agency will have greater regulatory powers than BFAD and will be able to retain income it generates. Read the article »

  • Trade Group Urges Australian Govt to Support Clinical Trials

    Posted: 20 August 2009

    The head of the Australian pharmaceutical trade group, Medicines Australia, urged that country's government to take steps to reverse the decline in clinical trial activity in Australia. The group's chief executive, Ian Chalmers, wrote in a commentary published last week that the health and economic benefits derived from clinical trials are in jeopardy and called for "urgent action by governments to speed up times for trial start-up, halt growing costs and better connect patients with suitable trials." Read the article »

  • FDA Speeds Process for Banning Bad Trial Investigators

    Posted: 20 August 2009

    The US Food and Drug Administration (FDA) has developed new procedures to help speed the process for barring noncompliant clinical trial investigators from future research. The new process will set specific timeframes and assign responsibility for each step to specific areas within the agency. The disqualification process will now be centralized in FDA's Good Clinical Practices Office, whereas previously, responsibility resided in the center that initiated the disqualification action. Debarments will be centralized in the Office of Enforcement. Read the article »

  • IND Access Rules Expand Access to Experimental Drugs

    Posted: 20 August 2009

    The US Food and Drug Administration's (FDA) new rules on expanded access to investigational medicines may lead to more patients and doctors requesting such experimental drugs. While most of the regulations were outlined in a 2006 proposal and have already been applied in practice, there are some changes in the final version that may be significant. One of the new regulations extends access to patients with serious or life-threatening diseases who lack other therapeutic options even if the individual is not seriously ill at the time. Read the article »

  • FDA Chief Talks Tough, CDRH Head Resigns, CDER Head Accused

    Posted: 13 August 2009

    It has been a busy week at the US Food and Drug Administration (FDA). Late last week, new FDA Commissioner Margaret Hamburg, addressing a gathering of the Food and Drug Law Institute (FDLI), promised a tougher stance on safety violations. This week, the director of FDA's Center for Devices and Radiological Health (CDRH), Daniel Schultz, resigned following months of criticism and internal turmoil over FDA's approval process for medical devices, and Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), was accused of ethical violations. Read the article »

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  • One Year After Heparin Crisis, USP Issues Revised Standards

    Posted: 13 August 2009

    The US Pharmacopeial Convention (USP) has released its revised standards for determining the purity and quality of the blood thinner, heparin. The new standards come a year after contaminated batches of the drug from China suddenly began causing extreme adverse reactions and even some deaths. The heparin was found to contain oversulfated chondroitin sulfate, a chemical with a molecular structure so similar to heparin that it was not detected in previous standard tests. USP's new standards include testing technology to detect such contaminants and will become official in October. Read the article »

  • Head of FDA's India Office Addresses Agency's Role There

    Posted: 13 August 2009

    Earlier this year, the US Food and Drug Administration (FDA) opened offices in Delhi and Mumbai, India, and recently the head of FDA India spoke to members of India's pharmaceutical community to discuss the agency's role there. FDA India Director Bruce Ross explained that the US regulator would not interfere with other Competent Authorities but rather has established a presence in India to monitor products and components destined for the US market. Read the article »

  • In Japan, Cost Controls Pose Challenge for Drugmakers

    Posted: 13 August 2009

    Pharmaceutical companies are finding financial success difficult in the Japanese drugs market, the world's second largest. While it would seem Japan's aging population would create a highly profitable market for drugmakers, it also has given rise to government policy that restricts pricing in order to reign in escalating medical costs. Government-mandated, regular price cuts seem to be paving the way for generics companies make some gains but foreign generics companies have been slow to penetrate the market. Read the article »

  • EMEA, FDA Launch Joint GCP Inspections Project

    Posted: 6 August 2009

    The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have joined together to in a collaborative effort to address international Good Clinical Practice (GCP) inspection activities. The initiative will allow the agencies to share information on inspection planning, policy and outcomes and conduct some joint inspections. As clinical research has become increasingly global, concerns have been raised about differing standards. EMEA officials call the initiative a step toward creating "a global regulatory network for the supervision of clinical trials." The new initiative will begin with an 18-month pilot phase on 1 September. Read the article »

  • 510(k) Sponsors Should Be Careful With Informal Communications

    Posted: 6 August 2009

    Companies involved in a 510(k) submission should be very cautious regarding informal communications with the US Food and Drug Administration (FDA), says a medical device submissions expert. Hogan & Hartson Partner and FDA device specialist John Smith recently warned 510(k) sponsors that such informal communications on the telephone or via email are "completely nonbinding on the agency," and advised against basing a company response solely upon such exchanges. In some cases, this informal feedback can be completely wrong because either the agency official does not fully understand the proposed submission or, in some cases, because the views of one individual FDA reviewer are not in line with the rest of the review team. Read the article »

  • Fast-Tracked H1N1 Vaccines Will Be Safe, Says WHO

    Posted: 6 August 2009

    After making statements that raised doubts about the safety of H1N1 vaccines that receive approval through fast-track approval processes, the World Health Organization (WHO) now says that such procedures do not reduce safety. WHO said this week that the H1N1 vaccines must be available quickly and in large quantities to have the greatest impact and noted that flu vaccines arrived too late to be effective in combating pandemics in 1957 and 1968. The current outbreak of H1N1 was declared a pandemic in June and is the fastest on record. Read the article »

July 2009

  • EMEA Says Fast-Tracked H1N1 Vaccine Will be Safe

    Posted: 30 July 2009

    The World Health Organization (WHO) has raised concerns about the accelerated approval process for the H1N1 vaccine in Europe but the European Medicines Agency (EMEA) says that any approved vaccine will be safe. To help make the vaccine available as soon as possible, EMEA is allowing vaccine makers to bypass large-scale human trials. As a result, the vaccine is expected to be available in countries including the UK, Greece, France and Sweden at least two months earlier than in the US and elsewhere. Read the article »

  • FDA Promises More Aggressive Diagnostics Oversight

    Posted: 30 July 2009

    The new director of the US Food and Drug Administration's (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety says the agency intends to take a more aggressive approach to oversight of diagnostics. In public comments last week, Alberto Gutierrez discussed his office's plans to tighten its regulatory control over commercial tests and address flaws in the 510(k) premarket notification program.Read the article »

  • Philippines Will Enforce Mandatory Drug Price Cuts

    Posted: 30 July 2009

    The Philippine government will enforce mandatory 50% price cuts for a group of medicines deemed essential, rejecting drugmakers' offers of lesser price reductions. The government had passed price control legislation but President Gloria Macapagal-Arroyo offered pharmaceutical companies an opportunity to voluntarily reduce prices on 21 essential medicines by 18 July. The companies countered with a compromise that would have lowered prices but not to the level of the legislated maximums. The price controls will take effect 15 August. Read the article »

  • FDA Accelerated Approval for Cancer Drugs Not Fast Enough

    Posted: 30 July 2009

    The US Food and Drug Administration's (FDA) "accelerated approval" program isn't doing enough to help speed potentially lifesaving cancer drugs to patients, says a new study. The program was created in 1992 to help patients with life-threatening diseases gain access to such medicines more quickly. However, according to a study supported by the National Cancer Institute and published in the Journal of Clinical Oncology, new cancer drugs have taken about seven years to gain approval, regardless of whether they were part of the accelerated process. Read the article »

  • FDA Wants Case-by-Case Criteria for Biosimilar Approval

    Posted: 23 July 2009

    The US Food and Drug Administration (FDA) wants Congress to allow the agency to make individual determinations about what data are needed to approve biosimilar medicines, according to FDA Commissioner Margaret Hamburg. "Our hope is that the legislation will enable us to move forward but with flexibility, so on a case-by-case basis we can develop the appropriate scientific criteria, including data requirements, for review and approval of these products," Hamburg said late last week. Read the article »

  • Euro Pharmacopoeia Announces Progress on Harmonization

    Posted: 23 July 2009

    The European Pharmacopoeia Commission announced progress toward international harmonization at the 134th session of the European Pharmacopoeia in France. As part of the group's collaboration with the US Pharmacopeia and the Japanese Pharmacopoeia, six harmonized texts that were approved at the recent Pharmacopoeial Discussion Group Yokohama meeting have been adopted by the European Pharmacopoeia Commission. Read the article »

  • Drugmakers Offer to Cut Prices in Philippines

    Posted: 23 July 2009

    Large pharmaceutical companies have offered to cut the prices of a number of widely-used drugs in the Philippines to avoid government-imposed price controls. The drugmakers announced the agreement on 18 July, which had been previously established as the deadline before price cuts were to be mandated. Read the article »

  • FDA Releases Draft Anticounterfeiting Guidance

    Posted: 23 July 2009

    In an effort to crack down on counterfeiting and make it easier to spot fake prescription drugs, the US Food and Drug Administration (FDA) has released a draft guidance on its plans for regulating drug additives. The document covers anticounterfeiting measures legitimate pharmaceutical manufacturers might use to authenticate their products. Read the article »

  • Clinical Trials in Emerging Markets Improved, Says Report

    Posted: 23 July 2009

    Researchers' ability to conduct high-quality clinical trials in emerging markets has improved "enormously" over the past 10 to 15 years, according to a new report from the Association of Clinical Research Organizations (ACRO). The report, commissioned by ACRO and conducted by VOI Consulting, acknowledges that legitimate concerns have been raised about clinical trials conducted outside traditional markets like the US and Europe but contends that standards for ethical research are global. Read the article »

  • US Senate Committee Approves 12-yr Exclusivity for Biologics

    Posted: 16 July 2009

    The US Senate's Health, Education, Labor and Pensions Committee voted this week to give biologic medicines 12 years of market exclusivity before allowing competitors to produce biosimilar versions. The Obama administration and others had pushed for a seven-year period to promote quicker access to cheaper versions, but biotech companies and supporters say the longer period of market protection is necessary to enable sponsors to recoup investments and to promote further innovation. Read the article »

  • UK Creates 'Innovation Pass' to Spur New Medicines

    Posted: 16 July 2009

    The UK's National Institute of Clinical Excellence (NICE) will administer a new "innovation pass" to make selected innovative medicines available on the National Health Service for three years. The program will give patients quicker access to highly novel drugs lacking clinical data and allow real-life data to be collected later. The program is part of the government's new Life Sciences Blueprint initiative to help promote development of the life sciences industry in the UK. Read the article »

  • Philippine Pres Will Not Extend Deadline for Drug Price Cuts

    Posted: 16 July 2009

    Philippine President Gloria Macapagal-Arroyo will not extend the deadline for pharmaceutical companies to comply with price restrictions for a number of widely-used prescription drugs. Drugmakers have until 18 July to voluntarily comply with the new cheaper-medicines law, a presidential spokesman said. President Arroyo met with multinational drug company representatives in a confidential meeting on 8 July to discuss the impending the price restrictions and has been accused of being overly accommodating to the foreign drugmakers. Read the article »

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  • Increased Scrutiny of Pay-for-Delay Deals Looms in US, EU

    Posted: 9 July 2009

    The legality of so-called "pay-for-delay" deals to delay generic competitors to brand name drugs is being challenged this week in both the US and EU. The US Department of Justice (DOJ) said such deals should be presumed unlawful and, after an 18-month investigation, the EU's Competition Commission has pledged to step up its scrutiny of the pharmaceutical industry's competitive practices, pay-for-delay deals in particular. Read the article »

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  • Researchers Say Regulation Plays Key Role in Device Development

    Posted: 9 July 2009

    Stanford University researchers say regulations influence much of the medical device development process and the speed at which regulatory requirements are met ultimately determines speed to market. The findings appeared in a comprehensive model of the medical device development process recently published by the Stanford team. The researchers also say stricter regulations and the advent of advanced technologies have combined to make the device development process much more complex in recent years. Read the article »

  • USP Revises Monographs to Address Contamination

    Posted: 9 July 2009

    The US Pharmacopeia (USP) is revising monographs for four pharmaceutical excipients because of concerns about contamination. Draft compendial methods for propylene glycol, sorbitol solution, sorbitol sorbitan solution and noncrystallising sorbitol solution have been posted online by USP. A procedure for maltitol solution is promised in the near future. The US Food and Drug Administration (FDA) requested revisions to the monographs because these excipients have been identified as being at risk of diethylene glycol adulteration. USP will accept comments until August 14. Read the article »

  • Drugmakers Warn Philippines Not to Restrict Pricing

    Posted: 9 July 2009

    Leaders of foreign drugmakers operating in the Philippines warned President Gloria Macapagal Arroyo against establishing price controls for widely-used prescription drugs. The president is set to sign an executive order establishing Maximum Retail Prices (MRPs) for at least 22 medicines. Drugmakers say they support efforts to make medicines more affordable but contend MRPs will "discourage existing and future investors in all industries." Read the article »

  • On Comparative Effectiveness: IOM Lists Priorities, VCs Expect Answers

    Posted: 2 July 2009

    In the US, the debate continues over how federally funded comparative effectiveness research (CER) will proceed as the influential Institute of Medicine this week issued its recommendations for 100 top priorities for CER. At the same time, venture capitalists are now said to expect drug and biotech companies seeking funding to have plans in place for CER during product development and to anticipate the postmarketing controls the US Food and Drug Administration (FDA) is likely to require.

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  • Medical Science Liaisons Allowed to Discuss Off-Label Use

    Posted: 2 July 2009

    While drugmakers' sales staff are prohibited by the US Food and Drug Administration (FDA) from discussing unapproved uses of their companies' products, medical science liaisons (MSLs) have more latitude. MSLs are considered medical rather than sales staff and typically have the scientific background to discuss implications of clinical trial data and other information that may be too technical or off limits for a sales rep. MSLs represent a small fraction of drugmakers' workforce but evidence suggests this area is growing. Read the article »

  • EMEA Issues Guidance on Nonclinical Safety Studies

    Posted: 2 July 2009

    The European Medicines Agency (EMEA) this week issued an International Conference on Harmonisation (ICH) guidance on the use of nonclinical safety studies in the development of human clinical trials. The Note for Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) is intended to provide recommendations for international standards for, and promote harmonization of such studies. It is scheduled to take effect in December.

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  • India May Require Certificate for Devices

    Posted: 2 July 2009

    India's Drug Technical Advisory Board (DTAB) has recommended requiring the Indian Conformity Assessment Certificate (ICAC) for medical devices manufactured, imported and marketed in the country. DATB's final draft guideline, called Schedule M-III, suggests medical device manufacturers apply for an ICAC mark and print the ICA mark specifications on the product label to ensure quality and safety. Read the article »June 2009

  • FTC Chair Calls For End to 'Pay-for-Delay'

    Posted: 25 June 2009

    US Federal Trade Commission Chairman Jon Leibowitz urged Congress to do away with so-called "pay-for-delay" deals in which makers of brand-name drugs pay to delay introduction of generic equivalents. Such settlements, said Leibowtiz, cost US consumers $3.5 billion per year. Read the article »

  • EMEA Seeks Public Input on Tranparency

    Posted: 25 June 2009

    The European Medicines Agency (EMEA) is seeking comments from the public regarding its draft transparency policy. The new policy is intended to foster a consistent approach to openness throughout the agency and encourage trust and confidence in its operations. Comments will be accepted until 25 September. Read the article »

  • Nanotech Holds Promise, Challenges for Medicine

    Posted: 25 June 2009

    The potential impact of nanotechnology on medicine is immense but there also are safety and regulatory challenges to be confronted. Experts say nanotechnology applications may prove particularly useful in biomedical devices, allowing new, better-targeted drug delivery, imaging and diagnostic tools, for example. However, the safety implications of nanotechnology are not yet well understood and years of development and regulatory scrutiny will likely be required before such applications become commonplace. Read the article »

  • Biosimilars Ripe for Global Expansion, US is Key

    Posted: 25 June 2009

    As Japan is set to receive its first biosimilar product and the US is moving closer to establishing an approval pathway for the category, a new study predicts "imminent expansion" for the biosimilar market. The report from Datamonitor contends that companies will not likely reap large financial gains initially but will vie to establish themselves early as major players in this sector, and the US market will represent nearly 90% of the global biosimilar market. Read the article »

  • Doctors Concerned About Patients Using Web to Self-Diagnose

    Posted: 25 June 2009

    Physicians are concerned about use of the Internet by patients to self diagnose, according to recent research. The research focused on primary care physicians in four cities to determine how they feel about the impact of the Internet on patients' health. Most felt there is a mix of good information and bad advice on the Internet. Participants found drug company product sites to be relatively neutral except in instances when such a site is "overly promotional." Read the article »

  • Obama: Savings Will Offset Cost of Health Reform

    Posted: 17 June 2009

    President Obama, in remarks delivered before the American Medical Association (AMA), promised that $950 billion in savings would cover most of the estimated $1 trillion his healthcare reform plan would cost. While Obama was received warmly by AMA members, many bristle at his unwillingness to support a cap on malpractice awards and it remains to be seen whether the organization, which is traditionally influential in healthcare policy, will support the President's reform plan. Read the article »

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  • Generic Drugmakers Must Contend With Deep Discounts

    Posted: 17 June 2009

    Sharply reduced prices of generic medicines in many European markets have also reduced the incentive for generic drugmakers to bid for contracts of drugs whose patents expire. The result is that some of the originator companies with large inventories of the formerly patented medicine end up retaining business as they are able to offer discounts and still profit. Generic companies have been forced to offer deep discounts, sparking calls for price supports. Read the article »

  • Cell Culture Production Speeds H1N1 Vaccine to Market

    Posted: 17 June 2009

    Two companies using cell culture production methods to produce vaccines for the H1N1 virus are on the verge of delivering their vaccines to market much faster than traditional processes would allow. One of the drugmakers says it is working to deliver its vaccine as early as next month. Traditionally, seasonal influenza vaccines must be mass produced using the albumin found in fertilized eggs as a growth media, but if cell culture production technologies are used, production time can be cut considerably.Read the article »

  • EU's Centralized Rx-to-OTC Switch Imperfect

    Posted: 17 June 2009

    The EU's new centralized procedure for Rx-to-OTC switches still has a few glitches to be worked out, say OTC industry executives. While the European Medicines Agency (EMEA) is now responsible for switch decisions, it determines only whether a product should be available over-the-counter or by prescription. EU Member States still have the authority over subcategorization and distribution channels, making the marketing process far from uniform. Read the article »

  • Prevention Does not Necessarily Mean Savings

    Posted: 17 June 2009

    There appears to be broad consensus among US lawmakers that the federal government should devote more resources to disease prevention, but it remains unclear whether such efforts would actually lead to cost savings. Researchers have examined previous government-sponsored prevention efforts aimed at chronic diseases and have found have found little reduction in either illness or costs.Read the article »

  • US Senate Votes to Give FDA Authority Over Tobacco

    Posted: 11 June 2009

    The US Senate approved a bill Thursday that would give the US Food and Drug Administration (FDA) regulatory authority over the manufacturing and marketing of tobacco products. The bipartisan measure was approved by a vote of 79 to 17 in the Senate. A similar bill was passed by the House of Representatives last month. The House will review the Senate version before a final bill is sent to President Obama to sign. Read the article »

  • FDA Releases Revised ICH Q8 Guidance

    Posted: 11 June 2009

    The US Food and Drug Administration (FDA) has released a revised version of its guidance on ICH Q8, the pharmaceutical development standards developed by the International Conference on Harmonisation. In the new version, FDA has added discussion of the concepts of quality by design (QbD) and critical quality attributes (CQAs), and covers the importance of identifying CQAs and using them to guide product and process development. Read the article »

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  • European Device Regs Set for Overhaul Next Year

    Posted: 11 June 2009

    The European Commission plans to move forward next year with plans to overhaul the EU's regulatory framework for medical devices. The plans announced last year include centralizing device regulation and have generated controversy and continuing discussion since. The Commission says it is still open to input from device makers and others. Its goal is to complete the changes by 2015. Read the article

  • A Few Emerging Markets Fuel Pharma Growth

    Posted: 11 June 2009

    The seven emerging economies of China, India, Russia, Brazil, Turkey, Mexico and South Korea will account for more than half of global pharmaceutical revenues in 2009, according to a new forecast. The 51% of worldwide revenues is up from 30% last year. The estimates come from IMS Health and while forecasters say some of the growth is due to sluggish growth in more established markets, emerging markets are growing in importance nonetheless.  Read the article »

  • Ethical Concerns Raised Re: Clinical Trials in Developing World

    Posted: 11 June 2009

    Researchers in India have expressed concern over clinical trials being conducted in that country, once again highlighting ethical considerations and pitfalls for drugmakers conducting trials in developing nations. The Centre for Studies in Ethics and Rights in Mumbai examined studies by several large drugmakers, concluding they violated the guidelines of the Indian Council of Medical Research. Read the article »

  • FDA Embraces Transparency

    Posted: 4 June 2009

    The US Food and Drug Administration (FDA) has created a new transparency task force, charged with recommending ways to provide more public access to information about the agency's decisions. Since much of the data FDA reviews are currently restricted as trade secrets, increasing transparency will not be easy, but President Obama and new FDA Commissioner Margaret Hamburg have both publicly supported increased openness. FDA has even set up its own transparency blog. Read the article »

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  • EU to Keep Drug Promo Restrictions in Place

    Posted: 4 June 2009

    EU Member States are expected to reject a proposal to ease restrictions on information drug companies are allowed to provide to the public about prescription drugs. The proposed Information to Patients Directive would have given drugmakers greater latitude to provide patients with information in Summaries of Product Characteristics (SPCs), labeling and package leaflets, among other things. No changes to the current ban on direct-to-consumer (DTC) ads were included in the proposal but critics argued the legislation would open the door to DTC drug advertising.  Read the article

  • Drugmakers Support 'Physician Out' Clause for CER

    Posted: 4 June 2009) 

    Drugmakers are supporting a bill to create a federal comparative effectiveness research institute that includes what has been called the "physician out" clause. The provision appears to protect against direct federal involvement in dictating specific treatments based on comparative and effectiveness and cost efficiency. However, some have drawn comparisons with the industry's involvement in the Medicare part D, "non-interference" clause and caution that this could again position big drug companies as protecting their own bottom lines at the expense of genuine progress in the public interest. Read the article »

  • Russia's OTC Market Growing, Complex

    Posted: 4 June 2009

    Russia's over-the-counter (OTC) medicines market is growing rapidly, creating a potentially lucrative opportunity for drugmakers, but complex regulations and regulatory processes present a significant challenge. Russia's OTC market is currently worth about $3.3 billion annually, but inefficiency, limited access to the Ministry of Health, and complex registration and importation procedures, among other things, create a very high barrier to entry and make expertise in Russian regulatory affairs an extremely valuable asset to foreign companies.  Read the article »

May 2009

  • TV Ads Should Avoid Distracting Elements, Says FDA

    Posted: 28 May 2009)

    The US Food and Drug Administration (FDA) advised drug and device makers this week to avoid using distracting images and music that could interfere with television advertisement viewers' understanding of possible side effects. The direction came in a draft guidance entitled, Presenting Risk Information in Prescription Drug and Medical Device Promotion. In the past, some have charged that advertisers have deliberately used such distracting elements to downplay the risks they are required to disclose. While the draft guidance is intended to apply to all forms of promotion, critics say it fails to adequately address online promotions. FDA will accept public comments on the draft for 90 days.Read the article »

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  • FDA's New Chiefs Stress Public Health Mission

    Posted: 28 May 2009

    Writing in the New England Journal of Medicine, the new Commissioner of the US Food and Drug Administration (FDA) Peggy Hamburg and Deputy Commissioner Joshua Sharfstein stressed the agency's primary mission of safeguarding public health over intermediate measures, such as the number of facilities inspected or number of medicines approved. The piece also emphasizes FDA's increased powers granted under the Food and Drug Administration Amendments Act of 2007 and took the agency to task over the recent salmonella outbreak in peanut products. In a separate statement last week, Sharfstein defended FDA's request for increased user fees.  Read the article

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  • EU Members Guide New Member States on Compliance

    Posted: 28 May 2009

    When new Member States enter the EU, they not only face regulations they must follow but often look to existing Member States to learn exactly how to comply. While new Member States have to prove they are able to comply with EU regulations, many have been unregulated in key areas prior to entering the EU. They essentially follow the rules by imitating existing Member States in a practice known as twinning. Read the article »

  • WHO Waits to Issue Pandemic Vaccine Advice

    Posted: 28 May 2009

    Top officials at the World Health Organization (WHO) say the organization will continue to monitor the spread of the H1N1 virus before issuing guidance on the production of pandemic flu vaccines. WHO expects to make recommendations sometime this summer.  Read the article »

  • Group Creates Wiki to Stir Discussion of Draft Autoinjector Guidance

    Posted: 28 May 2009

    The Combination Products Coalition (CPC) has initiated a wiki project to help facilitate public discussion on regulatory issues affecting combination products, including the US Food and Drug Administration's (FDA) recently issued draft guidance on autoinjectors. CPC is encouraging comments on the draft guidance, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, and offers suggestions on the wiki site. Comments are due to FDA by 27 July and CPC will maintain the wiki until 10 July. This guidance also will be covered in the July issue ofRegulatory Focus.  Read the article »

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  • In Europe, Challenges for Biosimilars

    Posted: 21 May 2009)

    The EU remains the only market with an established pathway for approval of biosimilars, yet the European marketplace for biologic products still presents a number of challenges. Concerns about safety and effectiveness compared to the original products remain and doctors have largely resisted biosimilars thus far. Additionally, the European Medicines Agency has ruled that biosimilars are not identical to the originals and many national governments have prevented automatic substitution at pharmacies.Read the article »

  • FDA Warning Letters Up, Time to Reassess?

    Posted: 21 May 2009

    Recent actions by the US Food and Drug Administration (FDA), including last week's widely-covered story about the agency's Warning Letter to Cheerios' maker General Mills, have observers speculating on a possible shift in regulatory philosophy at FDA. As of April of this year, the number of Warning and Untitled Letters issued by FDA's Division of Drug Marketing, Advertising, and Communications is already nearly as many as it had issued during the past three years combined. At least one prominent observer suggests it might be time for companies to take a hard, critical look at their current promotional materials in a new light.  Read the article

  • FDA Struggles to Meet the Challenge of Overseas Monitoring

    Posted: 21 May 2009

    The escalating globalization of pharmaceutical manufacturing operations has significantly increased the international monitoring burden on regulators like the US Food and Drug Administration (FDA). Even with a proposed funding boost and help from the European Medicines Agency in Europe and Therapeutic Goods Administration in Australia, FDA says it will only be able to maintain the current number of foreign inspections it conducts. It will, however, increase testing of imported products significantly. Read the article »

  • EU, Industry Provide 246 Million Euros to Boost European R&D

    Posted: 21 May 2009) 

    The EU and European drugmakers are collaborating to provide €246 million ($331 million US) in funding to drug research and development projects. The move is an effort to help re-establish Europe as the world's major pharmaceutical producer. The awards are being granted as part of the Innovative Medicines Initiative and mark the first time that government, drugmakers and research organizations have partnered in such a way.  Read the article »

  • Drugmakers Seek to Influence Comparative Effectiveness Research

    Posted: 21 May 2009

    Drugmakers concerned about the prospect of comparative effectiveness research (CER) being used to reject insurance coverage of expensive treatments are rallying Congressional allies to influence government-sponsored CER. The Pharmaceutical Research and Manufacturers of America has created the group, Partnership to Improve Patient Care, to advocate for a bill that would give industry a stronger voice in CER discussions.  Read the article »

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  • Medical Journalism Could be Advertising, Says EU Court

    Posted: 14 May 2009)

    The European Court of Justice has ruled that information about medicines created by third parties including journalists may constitute advertising, even if the publishers or authors have no commercial interest. The decision came in the case of a Danish journalist who praised the drug Hyben Total on his website. The court ruled such communications "may be regarded as advertising," according to Article 86 of EU Directive 2001/83/EC, but that it is up to Denmark's national court to make the final determination in this case. Read the article »

  • Congress Debates Allowing Lawsuits Against Device Makers

    Posted: 14 May 2009)

    Proposed legislation in the US would allow patients to sue medical device makers in state courts, even if the device in question has been approved by the US Food and Drug Administration (FDA). As it stands now, FDA approval preempts state law regarding devices. However, critics argue consumers need the additional protection the threat of legal action provides as FDA has failed to adequately protect the public against unsafe products on numerous occasions. Device makers and other advocates say that the bill, if passed, would stifle innovation. The US Supreme Court recently ruled against preemption in a case involving an improperly labeled drug but upheld the principle in a device-related case last year. Read the article

  • FDA May Get More Money, Tobacco Oversight Duty

    Posted: 14 May 2009

    President Obama is backing an effort to give the US Food and Drug Administration (FDA) an additional $300 million in funding at the same time a bill making its way through Congress would give the agency oversight over tobacco. If approved by Congress, the $300 million would be the largest funding boost in FDA history, according to the agency. However, the separate effort to make FDA responsible for monitoring the $89 billion tobacco industry would be an additional drain on agency resources, but could potentially give that industry the powerful watchdog it has historically lacked.  Read the article »

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  • Indian Pharma Sales in US Drop Sharply

    Posted: 14 May 2009

    Indian pharmaceutical exports to the US fell by nearly 40% in the five months between October 2008 and February 2009, according to the Federation of Indian Chambers of Commerce and Industry. Analysts believe some of decline is likely due to the US Food and Drug Administration's import ban on Ranbaxy products and research shows that Indian companies are losing US market share to other emerging market competitors such as China, Israel and South Korea.  Read the article »

  • Despite No Flu Pandemic, Drug and Vaccine Makers Ramp Up

    Posted: 14 May 2009) 

    The worst fears about the H1N1 or "Swine Flu" virus have not materialized, but pharmaceutical companies are ramping up to produce vaccines and regulators are bending the rules regarding flu medicines nonetheless. The World Health Organization has not classified the outbreak as a global pandemic and the global media, which was nearly in a frenzy two weeks ago, has largely moved on. Still, health officials warn that authorities must be prepared in case the virus does become more dangerous, and while some have accused the media of over-hyping the threat, others believe that media-fueled fears about the disease forced needed action to combat its spread.  Read the article »

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  • Experts Differ on Probable Impact of Comparative Effectiveness 

    Posted: 7 May 2009

    Speculation and anxiety continue over the impact the US government's comparative effectiveness research (CER) initiative will have on the healthcare product sector. Many point to the UK's NICE for clues about how CER will play out in the US, and some are concerned about the potential for the research to be used to limit patient choices. Others applaud the move and contend that more information about products can only help heathcare providers and consumers. Read the article »

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  • Clinical Trials in Rural Africa Face Logistical Hurdles

    Posted: 7 May 2009

    GSK Biologicals and the Bill and Melinda Gates Foundation have launched clinical trials across 11 sites in seven African countries. The trial sponsors have had to invest heavily in infrastructure to overcome the lack of existing communications and technology systems in Africa's "malaria belt," including in some cases, no electricity. As a result of these efforts, they hope to be able to make a vaccine available sooner than would otherwise be possible.  Read the article

  • FDA Issues Guidance on Full Product Lifecycle Quality Control

    Posted: 7 May 2009

    FDA has issued its final Guidance on the ICH Q10 quality control system, which is intended to help drugmakers implement good practices throughout a product's lifecycle. The International Conference on Harmonisation's (ICH) Q10 provides a model for effective quality management based upon Good Manufacturing Practices (GMPs), but going further, explicitly covering all aspects the product lifecycle from development through to discontinuation.  Read the article »

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  • CMS Won't Pay for Warfarin Genetic Tests

    Posted: 7 May 2009

    The Centers for Medicare and Medicaid Services (CMS) has determined it will not pay for genetic tests to help doctors personalize dosage of the blood thinner warfarin for individual patients. The decision marks a significant setback for the relatively new, but highly anticipated area of personalized medicine. A notice on the CMS website cited lack of evidence that the tests improved patients' health. Read the article »

  • Downturn Continues to Hit Medical Technology Cos.

    Posted: 7 May 2009

    The worldwide economic downturn is continuing to keep investors away from many healthcare product companies, including medical device makers and biotechnology firms. The lack of venture capital appears to be particularly challenging for biotech companies, which tend to be smaller and have less cash available to ride out the economic shifts.  Read the article »

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April 2009

  • WHO Holds Swine Flu Alert Level, FDA Allows Uncleared Usage

    Posted: 30 April 2009

    The World Health Organization (WHO) is holding its swine flu alert at level five, just short of a global pandemic, and the US has declared a public health emergency. The emergency declaration allows the US Food and Drug Administration to authorize emergency uses of the flu drugs Tamiflu and Relenza. WHO is continuing to monitor the situation and could declare a phase six pandemic, indicating a global pandemic.Read the article »

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  • US Bill Would Boost Inspections Abroad, Some Skeptical

    Posted: 30 April 2009

    Legislation has been introduced in the US Senate that would boost the number of inspections the US Food and Drug Administration (FDA) conducts abroad. Sens. Chuck Grassley (R-Iowa), ranking member on the Senate Finance Committee, and Ted Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pension Committee, co-sponsored the bill. Meanwhile, FDA's recently established foreign offices already have been met with skepticism abroad.  Read the article »

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  • New FDA Label Requirements for OTC Pain Meds

    Posted: 30 April 2009

    The US Food and Drug Administration (FDA) issued a final rule this week requiring over-the-counter pain relievers and fever reducers to carry warnings about the potential risks of liver damage and internal bleeding. The new rule applies to acetaminophen and a class of drugs known as nonsteroidal anti-inflammatory drugs or NSAIDs, such as aspirin and ibuprofen, as well as all products containing these ingredients.  Read the article »

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  • China, US Agree to Harmonize Medical Device Standards

    Posted: 30 April 2009

    Chinese and US Officials have agreed to harmonize standards for medical devices now being developed. The agreement came as the result of a meeting of the US-China Joint Commission on Commerce and Trade's Pharmaceuticals and Medical Devices Subgroup, recently held in Washington, DC. American and Chinese officials also discussed ways to streamline China's device registration process, considered cumbersome by foreign device makers.  Read the article »

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  • FDA Rules on Internet Ads Cause Confusion

    Posted: 23 April 2009

    The recent warnings issued by the US Food and Drug Administration for Internet ads the agency said failed to provide the required safety warning information have stirred debate and caused confusion in industry. FDA officials say such determinations are made based on advertising content without regard to the particular medium involved, but others point out that there seem to be some inconsistencies in that argument and that, in any event, the regulations may need to be updated to address issues that did not exist before modern electronic media. Read the article »

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  • Product Label Should Not Factor Into Off-Label Malpractice Cases

    Posted: 23 April 2009

    A law review article out this week argues that a drug or device's label information should not be admitted as evidence in medical malpractice cases involving an off-label use. The article appearing in theNorthwestern University Law Review makes the case that the label and accompanying product information cannot be used to judge either the standard of care or the physician's alleged breach of that standard when the product was prescribed for an off-label use.  Read the article »

  • US Stem Cell Guidelines Issued

    Posted: 23 April 2009

    The Obama administration issued guidelines late last week limiting government funds for embryonic stem cell research only to cells from excess fertility clinic embryos. The compromise appears to have more to do with political realities than science. Still, the action will mean that tax dollars may begin flowing to such research as early as this autumn.  Read the article »

  • UK Biotech Group to Provide Investment Money for Innovation

    Posted: 23 April 2009

    The UK-based BioIndustry Association announced this week it has established a £750 million strategic investment fund to help provide financing for emerging technologies. The group said the fund is designed to "promote research and development and harness commercially our world-class science base".  Read the article »

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  • Comparative Effectiveness Research Raises Concern 

    Posted: 16 April 2009

    Makers of pharmaceuticals and medical devices are concerned that findings resulting from US government-funded comparative effectiveness research will be used to limit patients' healthcare options. Funding of $1.1 billion for the research was included in President Barack Obama's economic stimulus package. The Obama administration hopes the research will help reduce wasteful spending on ineffective treatments. Read the article »

  • FDA's Tough Stance Hurts Small Drugmakers, Say Analysts

    Posted: 16 April 2009

    Analysts say the US Food and Drug Administration (FDA) has raised the bar for approval of new drugs, making it particularly difficult for smaller drug companies to endure, and in so doing the agency is jeopardizing the overall growth of the healthcare product industry. Critics say FDA has become more reluctant to approve new drugs due to safety concerns, often delaying decisions. Smaller companies are frequently industry innovators, but are less able than their large counterparts to have enough cash to wait out extended deadlines for approval decisions, decreasing the likelihood they can survive. Read the article »

  • ASEAN Nations Agree on Drug Safety, Quality, Pricing

    Posted: 16 April 2009

    The members of the Association of Southeast Asian Nations (ASEAN) have signed an agreement to ensure the safety, quality and pricing of pharmaceuticals in the region. The deal signed last week will eliminate trade barriers for pharmaceuticals among the member nations, bringing ASEAN one step closer to its goal of creating a single market along the lines of the European Union.  Read the article »

  • Eliminating Influence in Medical Research No Easy Feat

    Posted: 16 April 2009

    While several states have banned company gifts and favors for doctors and a bill has been introduced in the US Senate to compel full disclosure of financial relationships, eliminating influence will be no easy feat. Some contend that such laws will help, but addressing the influence of drugmakers who sponsor research supporting the safety and effectiveness of the drugs they make presents a more complicated challenge.  Read the article »

  • FDA to Require Review of Older Medical Devices 

    Posted: 9 April 2009

    The US Food and Drug Administration (FDA) announced it will require new proof of safety and effectiveness for 25 types of medical devices marketed prior to 1976. Those found to be high-risk will then undergo the agency's most stringent premarket review process. Critics say the move is long overdue. In January, the Government Accountability Office criticized FDA for failing to review categories of devices that have been on the market since before the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. Read the article »

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  • Bio-Pharma Consolidation Pushes Scientists From Top Jobs

    Posted: 9 April 2009

    The trend toward consolidation of biotech and pharmaceutical companies is resulting in fewer top executives with science backgrounds at the world's top drug developers. Analysts say there are a limited number of scientists who have the capability and inclination to run companies, and the increasing consolidation of drug development creates more urgent demand for executives skilled at developing alliances and marketing integration.  Read the article »

  • FDA Warns Drugmakers Over Internet Ads

    Posted: 9 April 2009

    The US Food and Drug Administration has issued warnings to 14 major drugmakers over Internet ads for their products. The ads used company-sponsored links on Web search engines such as Google to direct Web users to product information. In some cases, this included information on unapproved uses of the drugs.  Read the article »

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  • China's Health Reform Plan Aims to Expand Coverage

    Posted: 9 April 2009

    China's major, new healthcare reform plan aims to bring health coverage to more than 200 million uninsured Chinese citizens; and would also potentially create a huge and very attractive market for foreign drug and healthcare product companies. However, the plan still limits markups on drug prices and participation by foreign insurers.  Read the article »

  • Consumers Lose When Drugmakers Pay to Delay Generics 

    Posted: 2 April 2009

    Deals brokered by drugmakers to delay generic versions of 20 brand-name drugs cost US consumers at least $12 billion per year between 1993 and 2008, a Columbia University Law professor told members of Congress. The testimony was heard during a hearing of the House Energy and Commerce Committee's trade/commerce subcommittee. Committee Chairman Bobby Rush (D-IL) has introduced legislation to rein in such so-called "pay for delay" deals. Read the article »

  • API Monograph Pilot to Publish Results by End of Year 

    Posted: 2 April 2009

    A pilot project intended to advance harmonization of active pharmaceutical ingredient (API) monographs, should publish its first results before the end of the year. The pilot by the Pharmacopoeial Discussion Group, a cooperative effort among the pharmacopoeias in Europe, the US and Japan, began last summer with the goal of developing a single set of global API specifications.  Read the article »

  • Sharfstein Serving as Acting FDA Chief

    Posted: 2 April 2009

    Joshua Sharfstein, President Obama's selection as deputy commissioner of the US Food and Drug Administration (FDA), is now serving as the agency's acting commissioner while FDA nominee, former New York City health commissioner, Margaret Hamburg awaits Senate confirmation. Sharfstein was appointed last month at the same time Hamburg was nominated as commissioner. Read the article »

  • IRBs Vulnerable to Fraud, Says GAO

    Posted: 2 April 2009

    An investigation by the Government Accountability Office (GAO) has found that Institutional review boards (IRBs) are vulnerable to unethical manipulation and thus may not serve as the check on clinical trial safety they are intended to provide. GAO investigators conducted an operation in which an independent for-profit IRB was fooled into approving a false study protocol.  Read the article »

  • Biotechs Face Cash Crisis

    Posted: 2 April 2009

    Biotech companies are finding cash hard to come by, with even ardent biotech investors unwilling to commit funding. Separate reports from the UK and Canada point to similar trends. Nearly three-quarters of UK biotechs report difficulties in raising funds while a Canadian biotech exec says the sector is "in crisis."  Read the article »

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March 2009

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  • Choice of FDA's Top Two Fuels Speculation of Agency Split 

    Posted: 26 March 2009

    As US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein await confirmation, their backgrounds have fueled speculation that the agency may be divided into two entities to regulate food and medical products, respectively. High-profile failures such as the recent salmonella outbreak related to peanut products serve to bolster the perception that FDA cannot function effectively within its current structure. Read the article »

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  • Generic Drugmakers Benefit from Competitors' Violations

    Posted: 26 March 2009

    Some recent manufacturing violations have forced several major generic drugmakers to stop production. Analysts say the setbacks should benefit the firms' rivals by reducing competition. Competitors could see more favorable pricing in the generic market as well as limited or no competition on certain products as long as they do not experience any setbacks of their own.  Read the article »

  • Biosimilars Poised for Growth in Europe, Says Report

    Posted: 26 March 2009

    A new report finds that the number of biosimilar products available to the European market should gradually increase despite initial regulatory difficulties. The analysis, from Frost & Sullivan, holds that patents on big-selling biologics expiring and payers' perception of biosimilars as viable alternatives should help, representing "a massive market opportunity".  Read the article »

  • NEJM Editors Oppose Preemption in Device Cases

    Posted: 26 March 2009

    A recent New England Journal of Medicine (NEJM) editorial argues that medical device manufacturers should not be protected from litigation because of prior FDA approval. NEJM editors disagree with the Supreme Court's Riegel v. Medtronic decision, which established that precedent, and point out that it appears to contradict the Court's position on pharmaceuticals in the Wyeth v. Levine case. Read the article »

  • Baby's Death Causes Concern Over Clinical Trial Safety in India

    Posted: 26 March 2009

    Indian authorities are investigating the death of a baby last year during participation in a clinical trial the child should have been excluded from based on existing health problems. Lower costs have driven the growth of clinical trials conducted in India and elsewhere, but stories of safety issues continue to surface and some are questioning the abilities of companies and regulators to adequately monitor these studies. Read the article »

  • FDA Tells Staff to Keep Info Confidential 

    Posted: 19 March 2009

    Acting Commissioner of the US Food and Drug Administration (FDA) Frank Torti sent a memo to agency staff last week reminding them of the prohibitions against disclosing confidential information. In the memo, Torti reaffirms FDA's commitment to transparency and open government––a guiding principal of the Obama Administration––but also points out that disclosure of commercial information can result in disciplinary action or even criminal prosecution. Read the article »

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  • UN Drug Watchdog Offers Advice on Online Drug Sales

    Posted: 19 March 2009

    The United Nations' International Narcotics Control Board this week issued guidelines advising national governments on how to crack down on illegal Internet drug sales. Questionable online dealers have made abuse and illegal trafficking of prescription drugs an increasing global problem. There are few checks on the legitimacy of prescriptions and the drugs sold are often counterfeit and potentially dangerous. Read the article »

  • Generics Makers: Public Interest Must Factor Into Patent Cases

    Posted: 19 March 2009

    The proposed European Union (EU) Patent Court must consider the public interest in cases involving pharmaceutical patents, says a group representing generic drugmakers. The European Generics Medicine Association (EGA) supports the proposal for a central EU Patent Court, but in a recently released position paper, EGA stressed the importance of factoring in the interests of "other affected parties such as the public or the administration, not party in the litigation."  Read the article »

  • Two Biogeneric Bills Introduced in US Congress

    Posted: 19 March 2009

    A bill that would create a simpler pathway for approving generic biotech drugs has been introduced in the US Congress by Henry Waxman (D-CA) and a bipartisan coalition of supporters. It remains to be seen which bill is more likely to pass. Similar legislation has been defeated in the past as brand-name and generic drugmakers failed to agree on terms.  Read the article »

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  • Former NYC Health Chief is Pick for FDA Job

    Posted: 12 March 2009

    Sources say former New York City Health Commissioner Margaret "Peggy" Hamburg is President Obama's selection to be the next commissioner of the US Food and Drug Administration (FDA). The Obama administration sees Hamburg and its choice for deputy commissioner, Joshua Sharfstein, currently Baltimore's health chief, as appointees who will help FDA focus on its core mission of public health while sidestepping debate over pro- or anti-industry biases. Read the article »

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  • Obama Lifts Stem Cell Ban, South Korea Next?

    Posted: 12 March 2009

    President Obama lifted the Bush Administration-imposed ban on federal funding for embryonic stem cell research earlier this week, fulfilling a campaign pledge. In doing so, he vowed to let scientific innovation flourish free from the undue influence of ideology or political concerns. South Korea also is considering lifting its three-year ban on human embryonic stem cell research.  Read the article »

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  • Patent Reform Compromise Appears Close

    Posted: 12 March 2009

    A US patent reform bill seems headed for compromise on what has been one of the most divisive issues: how to determine damages for infringement. Advocates for high-tech companies and those supporting pharmaceutical manufacturers have been at odds over the issues. However, the two sides now appear to be close to an agreement that would have judges instruct juries on which factors to consider when determining damages, in particular, how critical the infringed patent was to the overall invention. Read the article »

  • Mergers to Bring Consolidation, Stability to Pharma

    Posted: 12 March 2009

    Consolidation in the pharmaceutical industry appears to be picking up steam with a number of recent, high profile mergers, including the just-announced Roche-Genentech deal. With the prospects of sharply declining sales as a result of expiring drug patents and generic competition, analysts say big pharma must consolidate in order to stabilize. Currently, the industry is one of a handful that sill has strong cash flows.  Read the article »

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  • US Supreme Court Rules Against Preemption in Wyeth Case 

    Posted: 5 March 2009

    The US Supreme Court ruled yesterday in favor of a Vermont woman who sued Wyeth in state court for inadequate labeling of the drug Phenergan despite the fact that the warning label had received approval from the US Food and Drug Administration (FDA). Diana Levine lost part of her arm as a result of gangrene caused by improper administration of the medicine and was awarded $6.8 million by a Vermont court. Drugmakers and the Bush administration agued that FDA approval preempts state lawsuits.Read the article »

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  • Kansas Gov Sebelius to Lead HHS 

    Posted: 5 March 2009

    President Obama last week selected Kansas Gov. Kathleen Sebelius as secretary of health and human services. Sebelius will be charged leading the administration's ambitious healthcare reform efforts and helping build bipartisan support for the plan. In his brief remarks on the formal announcement, Obama reaffirmed his commitment to reform despite some early opposition from Republicans and other critics.  Read the article »

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  • US Stem Cell Bill Introduced, Safer Alternative Discovered

    Posted: 5 March 2009

    A bipartisan bill was reintroduced in the US Senate last week that would allow federal funding for research using embryonic stems cells. In a separate development, early this week, researchers in Canada and the UK announced they have developed a safer way to transform human skin cells into an alternative to embryonic stem cells. In addition to the scientific implications, the development will no doubt ratchet up the debate over stem cells as opponents say the advance makes their use in therapy unnecessary. However, other scientific observers point out that while both approaches show promise, not enough is known to rule either one out.  Read the article »

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  • MHRA Urges Caution on Medicines for Children

    Posted: 5 March 2009

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is cautioning parents not to give children under six over-the-counter cough and cold medicines, saying the risks outweigh the benefits. MHRA officials say there is little evidence that such products are effective but they can cause sleep problems, allergic reactions or hallucinations.  Read the article »

  • Companies Use Social Networking to Recruit for Clinical Trials

    Posted: 5 March 2009

    Companies looking to recruit patients for clinical trials are increasingly turning to social networking sites like Facebook, MySpace and others to find willing participants. The sites themselves have even begun to explore business plans involving clinical trial recruitment. While such efforts certainly work on the well-known sites, niche sites like PatientsLikeMe, which allows members to build communities around particular conditions, may have a particular advantage in this arena.  Read the article »

February 2009

  • FDA Gets More Money and a 'To Do' List 

    Posted: 26 February 2009

    The US Food and Drug Administration will receive a proposed $2 billion in funding under theOmnibus Appropriations Act, about $300 million more than the agency requested. Funding has been increased dramatically and tied directly to specific safety measures in the wake of several recent serious safety failures, including last year's heparin contamination crisis and the recent salmonella outbreak linked to peanut products. Read the article »

  • Researchers Test Drug Dosage Based Upon Patient Genetics 

    Posted: 26 February 2009

    Researchers in seven European countries are testing the theory that the genetic profiles of individual patients can determine the appropriate dosage of a particular drug. They will use a mathematical formula based upon genetic information to determine the ideal dose of warfarin, a drug to prevent blood clots, in 2,700 individual patients.  Read the article »

  • Clinical Trials in Developing World Raise Concern

    Posted: 26 February 2009

    Clinical trials involving human subjects are increasingly being conducted in less wealthy regions, and a journal article published last week by Duke University researchers highlights a number of ethical and scientific concerns regarding the practice. Specifically, the researchers expressed concern about conducting trials in countries where regulations may be less stringent, getting and verifying informed consent may be more challenging and quality of research is harder for regulators in other countries to monitor. Between 1995 and 2005, the number of developing countries where trials were being conducted more than doubled, researchers say, while trials in the US and Western Europe declined. Read the article »

  • Obama Health Reform Plan a Mixed Bag for Drugmakers

    Posted: 26 February 2009

    President Obama's plan for healthcare reform is beginning to take shape and it includes some good and bad news for drugmakers. Analysts say Obama's support of universal healthcare coverage is generally a net positive, as is his support of R&D tax credits and increased investment in technology. Universal coverage would increase demand for both branded and generic drugs and reduce the need for free drug programs. However, increased incentives for patients to use generics could be a negative for brand-name drugmakers. The prospect of direct price negotiation with the government and federal support for comparative effectiveness research also are cause for concern.  Read the article »

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  • Patents Not to Blame for Lack of Drugs in Poor Countries

    Posted: 26 February 2009

    People in developing countries often lack adequate access to essential drugs, but a new study concludes that drug patents are not to blame. Only 19 of the 319 medicines on the World Health Organization's "Model List of Essential Medicines" actually have patent protection, suggesting poverty is the real cause, says a study from the Royal Institute of International Affairs.  Read the article »

  • FDA Device Lab Inspections Down, Says Report

    Posted: 19 February 2009

    US Food and Drug Administration inspections of laboratories testing medical devices have declined dramatically, according to a report from the Project on Government Oversight. While 33 inspections were conducted in 2005, only seven took place in 2007 and just one in 2008, said the independent watchdog group. In addition, no inspections are planned for this year, the report said.Read the article »

  • US Court Says Vaccines Not Linked to Autism 

    Posted: 19 February 2009

    A special US court last week ruled against several families who claimed that vaccines caused their children's autism. The families had sought payment under the National Vaccine Injury Compensation Program, claiming the measles, mumps and rubella vaccine had combined with other vaccine preservative ingredients to cause autism in their children. However, judges determined that evidence in the case did not support that the vaccines were the cause.  Read the article »

  • Addition of 'Facts Box' Would Help Consumers

    Posted: 19 February 2009

    A team of researchers at Dartmouth Medical School believe people would make better decisions about which medicines to take if drug advertising included a "facts box" clearly laying out a drug's pros and cons. The research team conducted trials showing drug ads with and without a facts box to patients and determined that consumers viewing ads with the boxes were more likely to make a choice the researchers deemed superior.  Read the article »

  • GSK CEO Discusses Responsibility, Pricing, Patents

    Posted: 19 February 2009

    GlaxoSmithKline chief executive Andrew Witty has spoken out recently about the pharmaceutical industry's responsibilities to society and has proposed new pricing for developing countries. Witty told The Guardian that he has seen "the consequences of these diseases at a kind of personal level ... and also the damage it does to a society."  Read the article »

  • EMEA Selects Advanced Therapies Committee Leaders

    Posted: 19 February 2009

    The European Medicines Agency (EMEA) has selected the chair and vice-chair of its newly established Committee for Advanced Therapies (CAT). The CAT is a multidisciplinary expert committee created to assess the quality, safety and efficacy of advanced therapy medicinal products and to follow scientific developments in the field.  Read the article »

  • Kansas and Tennessee Govs in Mix for HHS Job

    Posted: 12 February 2009

    President Obama still has not named his choice to lead the Department of Health and Human Services after Tom Daschle's withdrawal last week, but Kansas Gov. Kathleen Sebelius and Tennessee Gov. Phil Bredesen are the top two names being bandied about. Sebelius was in Washington this week for unrelated business and met with Obama officials. Meanwhile, Bredesen has come under attack for cuts he made to a state healthcare program. Read the article »

  • US Docs Face New Limits in Prescribing Narcotics

    Posted: 12 February 2009

    The US Food and Drug Administration (FDA) will launch a new program that will limit doctors' abilities to prescribe powerful pain medicines such as OxyContin and morphine. In response to hundreds of deaths per year as a result of inappropriate use of narcotics, FDA's new program aims to reduce errors and misuse by ensuring prescribing doctors are properly trained in the products' safe use. Read the article »

  • Obama Promises to Lift Stem Cell Restrictions

    Posted: 12 February 2009

    President Obama last week promised to sign an executive order lifting restrictions on stem cell research. He made the statement during a private meeting with House Democrats in response to a question from one of the congressmen present. Stem cell advocates are hoping for quick action on the matter.  Read the article »

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  • Malaysia to Increase Support for Biotech Industry

    Posted: 12 February 2009

    Officials in Malaysia have targeted the biotechnology industry for government support as a key piece of healthcare improvement and a driver of economic growth. The Malaysian government has allocated $3 billion (US) this year to enhance overall healthcare, including boosting the supply of available medicines, increasing research and strengthening biotech.  Read the article »

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  • With Daschle Out, Uncertainty Looms 

    Posted: 5 February 2009

    Now that former US Senator Tom Daschle has withdrawn his name from consideration as Health and Human Services (HHS) Secretary, President Obama's pick for the Food and Drug Administration chief and the future of his healthcare reform initiative are up in the air. Daschle clearly was to be a key player in the president's plan to reform the US healthcare system, and it remains unclear whether there is another top candidate for the HHS job waiting in the wings or if the president will press ahead in naming someone to the FDA post right away. Read the article »

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  • Stem Cell Therapy May Help MS Patients

    Posted: 5 February 2009

    Researchers at Northwestern University have had success reversing multiple sclerosis symptoms in patients in the early stages of the disease by using stem cell transplants. The stems cells, harvested from patients' bone marrow, actually helped rebuild patients' damaged immune systems and reverse neurological dysfunction for 81% of study subjects.  Read the article »

  • Generic Drugmakers Urge EU States to Ease Access

    Posted: 5 February 2009

    The European Generic medicines Association (EGA) has urged European Union (EU) Member States to make it easier for new generic medicines applications to be reviewed by national medicines agencies. The group cites a lack of resources to deal with growing demand. Generics now make up almost half of all pharmaceuticals dispensed in EU countries, but only 18% of pharmaceutical spending. Read the article »

  • The Debate Over Mail-Order Drugs

    Posted: 5 February 2009

    Champions of mail-order pharmacies have positioned the large-scale, automated operations as part of the cure to rising healthcare costs and a benefit to patients, improving prescription accuracy and healthcare quality. Critics, including the National Community Pharmacists Association, charge that mail-order pharmacies cannot offer the individual attention personal relationships of neighborhood pharmacies.  Read the article »

January 2009

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  • FDA Approves Stem Cell Study 

    Posted: 29 January 2009

    Late last week, the US Food and Drug Administration approved the first-ever clinical trial in humans, testing a therapy using human embryonic stem cells. Although the decision came only a few days after President Barack Obama took office, regulators insist political considerations played no role and, in fact, this particular trial had not been held up by Bush administration-imposed stem cell restrictions. Read the article »

  • UK's Drug Advisory Body Could See Changes

    Posted: 29 January 2009

    The UK's National Institute for Health and Clinical Excellence (NICE), the agency responsible for advising the National Health Service (NHS) on whether new drugs are worth paying for, will undergo a comprehensive review that may change the way it evaluates new medicines. Critics complain that NICE's existing practices have held up innovative drugs and created a disincentive to conduct research in the UK. Read the article »

  • Group of FDA Scientists Say They are Being Targeted

    Posted: 29 January 2009

    The nine US Food and Drug Administration (FDA) scientists who in May charged that agency officials illegally approved high-risk medical devices now say the agency has targeted them with a criminal investigation. The group wrote this week to President Barack Obama asking for the president's immediate intervention. An FDA spokesperson would neither confirm nor deny such an investigation. Read the article »

  • Big Drugmakers Differ on Growth Question

    Posted: 29 January 2009

    Two of the world's largest pharmaceutical manufacturers are taking two very different approaches in addressing challenges in the marketplace and the lack of new products on the horizon. While Pfizer is expanding through an announced purchase of Wyeth, GlaxoSmithKline's reaction seems to be to get leaner and more "biotech-like."  Read the article »

  • Most Americans Would Choose Generics

    Posted: 29 January 2009

    More than eight in 10 Americans would choose a generic drug over brand name medicines, according to a new Harris poll. The 81% saying they would opt for a generic is up from 68% two years ago. The poll also indicated that the percentage of people willing to pay more than $10 for a generic prescription has fallen.  Read the article »

  • Report Says FDA Device Testing Inadequate 

    Posted: 22 January 2009

    A congressional report released last week concluded that the US Food and Drug Administration is failing to test medical devices adequately for safety and efficacy. The report from the General Accountability Office called for immediate steps to fix the agency's processes. Read the article »

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  • $1 Billion Sought to Compare Treatments' Effectiveness

    Posted: 22 January 2009

    US House Democrats are seeking $1 billion in funding for an institute to compare the effectiveness of various medical treatments. The goal of the institute's research would be to help consumers, medical professionals and insurers make better informed decisions, as such comparisons are not currently available. Some have drawn comparisons with the UK's NICE.  Read the article »

  • EMEA Establishes Panel to Review Advanced Therapies

    Posted: 22 January 2009

    The European Medicines Agency (EMEA) this week established a new panel of experts specifically to review advanced therapies, creating a new opportunity for European companies to bring innovative new medical treatments to the public. The Committee for Advanced Therapies will be charged with reviewing the treatments within the existing regulatory framework.  Read the article »

  • Drug Manufacturing Increasingly International, FDA in India

    Posted: 22 January 2009

    As pharmaceutical manufacturing continues to grow increasingly international, many are concerned about the quality of drugs and the ability of regulators to monitor worldwide operations. After launching offices in China late last year, the US Food and Drug Administration opened Indian offices this week, in Mumbai and New Delhi.  Read the article »

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  • Half of Canadian Biotechs Could Fail in 2009

    Posted: 22 January 2009

    A Canadian Biotech advocacy group has warned that half of Canada's biotech companies could go out of business this year if nothing is done to prevent it. BIOTECanada is calling on the Canadian government to provide support to the country's $78.3 billion biotech sector or thousands of jobs, years of public investment in research and potentially hundreds of new discoveries could be lost. Read the article »

  • FDA Allows Drugmakers to Promote Unapproved Uses 

    Posted: 15 January 2009

    The US Food and Drug Administration this week finalized guidelines that allow pharmaceutical companies to provide doctors with information about unapproved uses of approved medicines. The move helps drugmakers expand markets for their products but has been sharply criticized by consumer advocates and some prominent lawmakers, including House Energy and Commerce Committee Chairman Henry Waxman (D-CA), who argue it allows companies to sidestep adequate testing.Read the article »

  • Pfizer to Lay Off Research Staff

    Posted: 15 January 2009

    Pfizer, the world's largest pharmaceutical company, announced lay-offs of as many as 800 researchers this week. As the drugmaker faces expiring patents on big-money products like Lipitor with few new alternatives on the horizon, pressure from investors to cut spending is building. Pfizer is far from alone in this regard and it and other drugmakers may increasingly look to external sources for research and development.  Read the article »

  • Obama Administration May Bring New Vaccine Incentives

    Posted: 15 January 2009

    While the Bush Administration's subsidies for vaccine development are not likely to continue under the Obama presidency, the new administration may create new incentives to stimulate vaccine markets. Obama's health team will likely look for ways to improve health services to underserved populations and vaccines could play an important role.  Read the article »

  • EC Revises Packaging Guidelines, Info for Blind

    Posted: 15 January 2009

    The European Commission has published its revised guidance on drug packaging readability requirements, including new standards for using Braille for patients who are blind or vision impaired. The new guidelines will take effect in June, replacing regulations that have been in force since 1998. Read the article »

  • FDA Launches Safety Pilot for Non-US Drugs

    Posted: 15 January 2009

    The US Food and Drug Administration has launched a pilot program to evaluate the practicality of developing a secure supply chain program for drugs produced outside the US. In the wake of last year's heparin contamination crisis, such a program could help FDA focus its efforts on drugs and drug products entering the US market from outside the secure supply chain, while expediting the entry of products inside the chain.  Read the article »

  • Big Pharma Looking for Biotech Deals

    Posted: 8 January 2009

    Big pharmaceutical companies are likely to be shopping for bargains as valuations of small biotechs have plummeted. With patents expiring on a number of brand name drugs and without many new ones in the pipeline, drugmakers' are hoping such acquisitions can help compensate for lost revenue. Read the article »

  • New Approach Needed at FDA, Say Critics

    Posted: 8 January 2009

    US President-elect Barack Obama has yet to name his choice for the next commissioner of the US Food and Drug Administration, but one thing is certain: whomever he selects will have no shortage of challenges to confront. Critics of the agency say that it is so broken, an entirely new approach is warranted.  Read the article »

  • FDA Approvals Up in 2008

    Posted: 8 January 2009

    US drug approvals rose last year due, in part, to an increase in medicines approved to treat rare disorders or diagnose diseases. The US Food and Drug Administration signed off on 25 novel treatments in 2008, up from 19 the previous year. The number of approvals in 2007 represented a quarter-century low for the agency.  Read the article »

  • China Encourages Adverse Event Reporting

    Posted: 8 January 2009

    A new regulation released this week by China's State Food and Drug Administration encourages the Chinese public to actively report adverse outcomes resulting from the use of medical devices. Individuals and organizations can report adverse events to provincial medical device monitoring centers or local drug administrations.  Read the article »