Select a region
North America Europe Asia

Latest News: 2010

December

  • FDA Delays Social Media Guidance Until at Least Q1 2011

    Posted: 23 December 2010

    As many suspected, the US Food and Drug Administration (FDA) will not issue any guidance on promotion of drugs and devices via social media channels before the end of the year, pushing its target date to the first quarter of 2011. FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) confirmed in a statement that it has been researching draft guidance in six areas: responding to unsolicited requests; fulfilling regulatory requirements when using tools with space limitations; fulfilling postmarketing submission requirements; online communications for which manufacturers, packers, or distributors are accountable; use of web links; and correcting misinformation. According to the statement, DDMAC’s new goal is to address at least one of these areas in the first quarter.

    Read more:
  • US, Europe Take Different Approaches on Avastin

    Posted: 23 December 2010

    A move last week by the US Food and Drug Administration (FDA) toward revoking its approval for a popular drug’s use in fighting breast cancer, and the different tack taken by the European Medicines Agency (EMA), have sparked debate and underscored the two agencies’ differences. FDA says Roche’s Avastin does not prolong the life of breast-cancer patients and that its indication for breast cancer should be removed, although the drug would remain FDA-approved for other cancers. EMA, on the other hand, supports continued use of the drug for breast cancer, but only in combination with a specific chemotherapy drug. Authorities in Canada have not yet made a decision.

    Read more:
  • Diagnostic Tests Can Be Patented, Says US Court

    Posted: 23 December 2010

    A US appeals court has ruled that diagnostic medical tests can be patented, opening the door for companies looking to respond to increased demand for personalized diagnostics. Courts have generally held that patents cannot be granted for “laws of nature, physical phenomena and abstract ideas,” but the plaintiff in the case, Prometheus Laboratories Inc., successfully argued that its tests involve an application of a law of nature, not the law itself.

    Read more:
  • Recycling Pacemakers Could Save Lives in Developing World

    Posted: 23 December 2010

    Pacemakers, which cost from $10,000 to $50,000 in the US, are typically discarded or buried with people when they die, but a new program seeks to recycle usable pacemakers for needy patients in developing countries. The program from doctors at the University of Michigan, with support from a nonprofit group, encourages people to send them the pacemakers in the mail instead. While the National Funeral Directors Association advises against shipping pacemakers because currently, they would be considered by the US Food and Drug Administration (FDA) as medical device distributors subject to federal and state requirements, program leaders are seeking FDA approval to ship and export the devices.

    Read more:
  • India, EU Resolve Dispute Over Generic Drugs Seizures

    Posted: 16 December 2010

    The European Union and India resolved a dispute over generic drugs that should remove obstacles to Indian drugmakers exporting products to the developing world, officials said. Indian Commerce and Industry Minister Anand Sharma said the EU's trade chief, Karel De Gucht, told Indian negotiators during an EU-India summit in Brussels that the issue had been resolved, and De Gucht confirmed the agreement.

    Read more:
  • FDA Issues Draft Guidance on Drug Codevelopment

    Posted: 16 December 2010

    The US Food and Drug Administration (FDA) issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. The move has been in the works for a while. Some of the regulatory challenges involved in developing combination therapies were highlighted at a September 2009 panel hosted by the Brookings Institution and the Friends of Cancer Research.

    Read more:
  • FDA Pushes Back Delivery Date for UDI Rule

    Posted: 16 December 2010

    The hoped-for regulation on the US Food and Drug Administration’s (FDA) unique device identification (UDI) framework will not come out until the first part of 2011, but companies should start taking steps to implement UDI now, an agency official says. FDA had hoped to issue the UDI rule—about three years in the making—by this December, but it appears "that is not going to happen," according to FDA.

    Read more:
  • No New Regulations for Synthetic Biology

    Posted: 16 December 2010

    The President’s bioethics commission says there is no need to temporarily halt research or to impose new regulations on the controversial new field known as synthetic biology. In a report issued Thursday, the Presidential Commission for the Study of Bioethical Issues says that at present, the technology—which involves creating novel organisms through the synthesis and manipulation of DNA—poses few risks because it is still in its infancy.

    Read more:
  • Stem Cell Funding Battle Goes to Federal Appeals Court

    Posted: 9 December 2010

    This week, a US federal appeals court panel heard testimony in the case to determine whether the federal government can fund research involving embryonic stem cells. The court is reviewing a US district court decision blocking funding for stem cell research made possible under the Obama Administration's stem cell research guidelines. The earlier ruling found the Administration’s policy in violation of the Dickey-Wicker Amendment, a 1996 law that prohibits federal funding for "research in which a human embryo or embryos are destroyed.” The Administration has argued that the spending is legal because the stem cell lines used in the research were created outside the government and government funding is not supporting the destruction of embryos.

    Read more:
  • EMA Increases Public Access to Documents

    Posted: 9 December 2010

    The European Medicines Agency (EMA) published its new policy to allow greater access to documents related to medicines for human and veterinary use. The new policy is part of EMA’s move toward greater transparency and comes after criticism from the European Ombudsman. Under the new policy, the agency will permit access to all business-related documents unless there is a need to respect arrangements with non-EU regulators or international organizations, or to protect individual privacy. As a general rule, EMA will release documents following finalization of procedure concerning medicines in order to protect the decision-making process.

    Read more:
  • CDRH’s Maisel Says FDA Not Risk Averse, Stresses Predictability

    Posted: 9 December 2010

    William Maisel, the US Food and Drug Administration’s (FDA) top scientist for medical devices, said in an interview published this week in the Minneapolis Star Tribune that FDA is not risk averse, but also emphasized the importance of increasing predictability and transparency at FDA. Maisel, who had been a vocal FDA critic prior to his appointment, said that there is a need for device companies and their backers to have greater certainty about what it will take to bring a product to market. When asked about the agency’s reputation lately for being risk averse, he said “We're very interested in making good decisions. And a good decision doesn't mean that there's no risk. A good decision will promote the public health. It's about striking the right balance.”

    Read more:
  • Chinese Biotech Poised for Significant Growth

    Posted: 9 December 2010

    The Chinese government intends to aggressively invest in development of next-gen technology industries and has identified biotech as one of seven priority industries poised for explosive growth over the next 10 years. China is reportedly considering investing up to $1.5 trillion in these industries over the next five years. Zhou Zixue, chief economist of China’s Ministry of Industry and Information Technology, projects that biotech in China will grow at an annual rate of 24.1% between 2011 and 2015, and at the slightly slower pace of 21.3% in the following five years. Observers and stakeholders note that regulatory agencies like the US Food and Drug Administration (FDA) are under increasing public and legislative pressure to increase safety standards making less restrictive environments like China’s increasingly attractive to healthcare product developers and marketers.

    Read more:
  • FDA Gets Mixed Reviews From Industry, Public 

    Posted: 2 December 2010

    Drugmakers and medical device manufacturers do not believe the US Food and Drug Administration (FDA) is working as efficiently as it should in reviewing healthcare products, and US consumers have lost confidence in the agency, according to a new study from PwC (formerly PricewaterhouseCoopers). While 80% of industry respondents said FDA’s guidance about agency expectations has improved, 48% said the agency has not been clear about the purpose of user fees or how they are used, and 46% do not believe the fees have expedited the review process. Meanwhile, most consumers are unaware of the user fees and 70% do not agree such fees should be part of the process. Additionally, one-third of consumers have lost confidence in FDA over the past two years in the wake of several high-profile recalls.

    Read more:
  • NICE Chief Says Agency Still Has Role to Play

    Posted: 2 December 2010

    The chief executive of the UK’s National Institute for Health and Clinical Excellence (NICE) has said he agrees with plans to introduce a value-based pricing system in 2014 and insists the agency will still play an important role in the new scheme. In his first public comments since it was announced that NICE will no longer issue binding guidance to the National Health Service, Sir Andrew Dillon remarked "Reports of the institution's death have been greatly exaggerated," and said "What I do know is that NICE will continue to assess clinical and cost-effectiveness of new pharmaceuticals. But it seems we won't be asked to formally recommend, in the terms we have used to date, how a new drug should be used."

    Read more:
  • EU Lawmakers Vote for Stricter Patient Drug Info Rules

    Posted: 2 December 2010

    The European Parliament voted last week to further tighten proposed new rules that would allow additional access to information about medicines to European consumers. Parliament adopted proposals that would require drugmakers to provide additional information on labels and packaging, and would prohibit the distribution of drug information in print media such as newspapers as well as on television and radio, as originally proposed. The proposals will now go to Member States for approval.

    Read more:
  • Shuren Sharply Criticizes Stanford Device Cost Study

    Posted: 2 December 2010

    The director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), Dr. Jeffrey Shuren, sharply criticized the findings of a recent study that argued more than three-quarters of the cost to bring a medical device to market in the US is devoted to satisfying FDA requirements. Shuren called the study from researchers at Stanford University and supported by AdvaMed “highly flawed,” and disputed the cost findings. "The cost issue was based on the first time the company talked to the FDA through the time it went to market," said Shuren. "But, we talk to companies when the product is under development, which you don't get in the European Union. We got dinged for talking to companies early." One of the study’s authors countered that the issue isn’t that FDA is communicating with companies early but that the “process has become exceptionally difficult, whereas in Europe the process is exceptionally straightforward.”

    Read more:

November

  • Study Shows Inconsistent Doctor Response to FDA Warning

    Posted: 18 November 2010

    A Mayo Clinic study examined doctors’ prescribing patterns in response to warnings from the US Food and Drug Administration (FDA) and found that patients may be exposed to different levels of risk depending upon where they live. The study looked specifically at prescriptions of the diabetes drug Avandia before and after FDA mandated a black box warning in 2007 after the drug was shown to be associated with increased risk of heart attack. While nationwide use of Avandia dropped dramatically after the warning requirement, the decrease varied by region. Researchers say the reasons for this aren't clear, but the manner in which doctors are made aware of FDA warnings and how they react, state health insurance plan drug coverage policies, the influence of prominent local doctors and drug-company marketing may be factors.

    Read more:
  • India Introduces Stricter Guidelines for Clinical Trials

    Posted: 18 November 2010

    India’s Central Drugs Standard Control Organization (CDSCO) has created new, stricter guidelines for clinical trial inspections. The guidelines are part of a broader government effort to solidify India’s regulatory framework for clinical research, protect patients and foster increased confidence in research conducted in India. The guidelines provide specific direction for CDSCO inspectors and officers as well as contract research organizations involved in clinical trials of drugs, biologics and medical devices regulated by India’s Drugs and Cosmetics Act and for the clinical trial sites themselves.

    Read more:
  • Report Questions Canadian Drug Safety System

    Posted: 18 November 2010

    A new report from the independent Health Council of Canada raises concerns about the limitations of the Canadian drug safety system and calls for “vast improvements.” According to the report, over the past 25 years, the percentage of drugs withdrawn from the Canadian market has not changed, but the number of people exposed to unsafe drugs has increased. The researchers say Canada’s postmarketing surveillance system is limited and flawed. “Health Canada cannot require companies to conduct postmarket studies or change drug labels after the product has been approved unless significant new safety issues have been identified. And although it has the authority to order drugs to be withdrawn from the market, they rarely exercise this power,” said one of the report’s lead authors.

    Read more:
  • Pharma Companies Develop Less Than Half of New Drugs

    Posted: 18 November 2010

    A new analysis of more than 250 drugs that were approved by the US Food and Drug Administration (FDA) from 1997 to 2008 finds that drugmakers were responsible for less than half of the innovative drugs discovered. According to the analysis published in Nature Reviews Drug Discovery, 58% of approved drugs were developed by pharmaceutical companies, 18% by biotechs and 24% by universities. Of the approved drugs, 118 were found to be novel in their mechanisms of action and chemical structure. Of that group, drugmakers were responsible for 44% percent, while biotech developed 25% and universities the remaining 31%. Overall, about two-thirds of pharma companies’ approved drugs were classified as follow-ons.

    Read more:
  • FDA Says Most Drugmakers’ Postmarketing Studies on Track

    Posted: 11 November 2010

    Most companies that have had their pharmaceutical or biological products approved by the US Food and Drug Administration (FDA) are meeting their regulatory postmarketing obligations on time, according to an FDA study released this week. The study, done under a contract with Booz Allen Hamilton, examined the status of 1,551 postmarketing studies/clinical trials and found that 40% of the postmarketing studies had been closed by FDA. And of the remaining 60%, most were in progress and on schedule or the final reports had already been submitted for FDA review.

    Read more:
  • US Biosimilar Pathway Still Has Long Way to Go, Says Hamburg

    Posted: 11 November 2010

    The US Food and Drug Administration held a two-day public meeting on the pathway for biosimilar approval but FDA Commissioner Margaret Hamburg recently indicated the agency still has much work to do to establish that pathway. "It's a complex challenge. I can't put dates on our timelines for implementation," Hamburg said recently. FDA observers say it could take months or even years for the agency to come up with the specifics and it will be years before patients and insurers see the benefit of lower-priced biologic products on the market. However, FDA may still issue early guidelines and approve biosimilars on a case-by-case basis.

    Read more:
  • Attempt to Revive Canada’s Drug Access Law Rejected

    Posted: 11 November 2010

    An attempt to make Canada's Access to Medicine law more workable was rejected by a majority of the Canadian House of Commons Standing Committee on Industry, Science and Technology last week, effectively killing the reform. The law was passed in 2004 in an attempt to ease exports of lower-cost medicines to developing countries, but it proved to be too complex and bureaucratic to work well in practice. In six years, it was only used once, to send a shipment of HIV/AIDS drugs to Rwanda. The proposed amendment would have lowered the barriers to use, but committee members rejected the proposal out of concern for intellectual property rights and a potentially negative impact on drug research and development.

    Read more:
  • UK, Japan to Share Med Device Regulatory Info

    Posted: 11 November 2010

    Japan and the UK have agreed to share regulatory information regarding medical devices and other therapeutic products, according to a letter from Kent Woods, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency, to Tatsuya Kondo, chief executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and posted on PMDA’s website. While the agreement it is not legally binding, it is intended to “facilitate access to safe, effective and high-quality products and share information related to these products.”

    Read more:
  • FDA Holds Biosimilars Meeting

    Posted: 4 November 2010

    The US Food and Drug Administration (FDA) this week held its much-anticipated two-day public hearing aimed at addressing the complexities of an abbreviated approval pathway for biosimilar products. US healthcare reform measures passed this year require FDA to create an abbreviated approval pathway for biosimilars. But because biosimilars are not identical to the original, branded medications they are based on, small differences can produce very different reactions in patients, and the regulatory approval process must address these considerations. FDA is now faced with the challenge of determining how to ensure biosimilars match brand-name treatments in both safety and efficacy. Ultimately, the cost benefit is likely years away.

    Read more:
  • Study Calls Facebook “Wild West” of Health Info

    Posted: 4 November 2010

    A new study from Harvard and Brigham and Women’s Hospital in Boston calls Facebook and other social networks a “Wild West” of medical misinformation. The study appears to bolster the case for healthcare companies to engage in social media as reliable sources of information about their own products and the conditions they treat, and to involve regulatory professionals in social media planning efforts. The study focused on the 15 largest diabetes communities on Facebook and found that more than one in four comments posted on such community pages is promotional in nature, generally for unapproved products, researchers said.

    Read more:
  • Asia-Pacific Poised for Emphasis on Innovative R&D

    Posted: 4 November 2010

    Drugmakers in the Asia-Pacific region are "increasingly adapting their business models from the production of generic drugs towards more high-risk, high-return R&D," according to a new report. The analysis from CMR International cites a rise in clinical trial activity outside the US as well as an increase in patent challenges and molecular development in the region. Between 2002 and 2008, the percentage of North American patients recruited globally for clinical trials fell from 53% to 32%. Over the same period, trial participants in the Asia-Pacific region increased from 6% to 11%, while Europe showed marginal growth from 14%-17%.

    Read more:
  • Australia’s TGA Seeks Input on Device Regulatory Framework

    Posted: 4 November 2010

    Australia’s Therapeutic Goods Administration (TGA) is seeking public comment on improving the regulatory framework for medical devices. "The TGA is Australia's watchdog on the safety and effectiveness of medicines and medical devices and, as part of its reform agenda, the TGA is seeking public input into how its regulatory processes, including transparency about its decisions, meet the expectations of the public and of the industry it regulates," the Parliamentary Secretary for Health, Catherine King, said in a press release. "This follows a recommendation for an enhanced regulation of medical devices by the Review of Health Technology Assessment in Australia, released by the Australian Government in February 2010,” she continued.

    Read more:

October

  • Senators, FTC Commish Disagree on Pay for Delay

    Posted: 28 October 2010

    A bipartisan group of US Senators is calling for the removal of a ban on generic drug settlements from a pending appropriations bill, while the head of the Federal Trade Commission (FTC), again, defended his agency’s support for the ban. The so-called “pay-for-delay ban” would outlaw the practice of brandname drugmakers paying makers of generics as part of settlement deals that delay generic versions. In an interview with Pharmalot, FTC Commissioner Jon Liebowitz said “We’re sort of the lonely eminence on this issue. But we believe we’re so right on the issue. I think it’s pretty meaningful.”

    Read more:
  • UK’s NICE Could Lose Cost-effectiveness Authority

    Posted: 28 October 2010

    It seems likely that, by the end of 2013, the UK's National Institute for Clinical Excellence (NICE) will lose its authority in determining the cost-effectiveness of approved medicines, according to officials. A new value-based pricing system will set drug prices to reflect a product's value at the outset, making NICE’s assessment after the fact unnecessary. The new pricing system will likely come into effect at the start of 2014, after the current Pharmaceutical Price Regulation Scheme contract between industry and government expires. Under the new system, the price of a drug would reflect “everybody's agreed perception of the value provided,” said Lord Howe, Parliamentary Under Secretary of State at the Department of Health.

    Read more:
  • China’s SFDA Pursues Source of Counterfeit Drug

    Posted: 28 October 2010

    China’s State Food and Drug Administration (SFDA) may have identified the manufacturer responsible for producing counterfeit versions of the antibody drug Avastin that led to infections and other adverse effects in 61 patients at a Beijing hospital. Avastin has recently been approved in China as a treatment for colorectal cancer, but in this case was being used off-label to treat age-related macular degeneration, a leading cause of blindness.

    Read more:
  • Drugmakers Top Fraud Settlement List

    Posted: 28 October 2010

    Pharmaceutical companies occupied eight of the US Department of Justice’s (DOJ) top 10 fraud settlements in the last year, according to an advocacy group called the Taxpayers Against Fraud Education Fund. With more baby boomers becoming eligible for Medicare coverage, the government has begun spending more on prescription medicines attracting increased scrutiny from federal authorities. In recent years, DOJ has increasingly pursued cases of off-label marketing by drugmakers.

    Read more:
  • FDA May Raise Standards for Generic Drugs

    Posted: 21 October 2010

    The US Food and Drug Administration (FDA) may tighten standards for how close generic drugs must be to their brand-name equivalents, according to Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. Patients and some employees of generic drugmakers have reported that some generics are not as effective as the originals, said Woodcock. “I've heard it enough times from enough people to believe that there are a few products that aren't meeting quality standards,” she said. There is increased attention to this issue as more prescriptions are being filled with generic medicines in an effort by insurers to cut costs, and as more popular, brand-name drugs lose their patent protection.

    Read more:
  • EMA strengthens Conflict-of-Interest Rules

    Posted: 21 October 2010

    The European Medicines Agency (EMA) has published new rules on how it will handle potential conflicts of interests among its scientific experts. The agency says the new rules are intended to balance the need to secure Europe’s best scientific experts for the evaluation and supervision of medicines while also ensuring these experts have no financial or other interests that could bias their decisions. According to EMA, potential conflicts of interests are classified into three categories: direct, indirect and no interests. Experts are required to provide a signed declaration of interests form, and the agency will screen all declared interests of proposed committee members prior to their formal nomination.

    Read more:
  • Hamburg Promises to Address 510(k) Reform Concerns

    Posted: 21 October 2010

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg this week promised medical device industry leaders that FDA’s planned changes to the 510(k) clearance process will take into account any “substantive concerns” raised during the public comment period. “We are really undertaking a serious, thoughtful process of review of all the comments as we shape the process," said Hamburg. “As we go forward, there will be still be opportunities for comment, feedback, discussion and shaping.” She also said the agency would release a summary of the comments received and the recommendations it plans to implement.

    Read more:
  • Cancer Patients Blood Dope to Get Into Trials

    Posted: 21 October 2010

    Three cancer patients have been reported to have received blood transfusions for the sole purpose of meeting eligibility criteria for clinical trials for novel chemotherapy agents, according to a group of Canadian researchers. The three instances in advanced cancer patients over a one-year period were reported by researchers at Sunnybrook Health Sciences Center in Toronto. The research team cautioned against the practice in a letter to the editor of the New England Journal of Medicine, and warned other researchers and institutional review boards to carefully consider eligibility criteria in trial design, and to be alert to laboratory values that could be manipulated by transfusions.

    Read more:
  • US Lawmakers Ask FDA to Delay 510(k) Changes

    Posted: 14 October 2010

    A bipartisan group of 12 lawmakers has asked US Food and Drug Administration (FDA) Commissioner Margaret Hamburg to provide additional insight into proposed changes to the 510(k) review process for medical devices and to delay some of the more controversial proposals. The request came this week in a letter to the commissioner from members of the House Energy and Commerce Committee. In the letter, the lawmakers raised concern that five of FDA’s recommendations could create new hurdles to getting products to market. Medical device companies have already expressed their concern about the effect the changes could have on innovation and competition.

    Read more:
  • First Human Stem Cell Trial Begins

    Posted: 14 October 2010

    Doctors have begun the first official trial using human embryonic stem cells in patients after getting approval for the privately funded study from the US Food and Drug Administration (FDA) in July. A patient, partially paralyzed by a spinal cord injury, was treated last week at a hospital in Atlanta, one of seven sites participating in the study being conducted by Geron Corp. The trial is designed to test the treatment’s safety. After years of delays and setbacks, the milestone was welcomed by scientists and many patient advocates eager to move stem cell research from the laboratory to the clinic and eventually develop and approve stem-cell-based treatments.

    Read more:
  • US Supreme Court Hears Vaccine Liability Case

    Posted: 14 October 2010

    The US Supreme Court heard arguments this week in a case to determine whether drug companies can be sued for claims of serious side effects from childhood vaccines. Vaccine advocates are concerned that without liability protection, the vaccine makers will be driven from the market and, without available vaccines, public health will be put at risk. The plaintiffs in the case say their 18-year-old daughter suffered adverse effects from a vaccine she received as an infant. The justices agreed that Congress has gone to great lengths to shield vaccine makers from suits by the few who have had an adverse reaction to a vaccine approved by the US Food and Drug Administration (FDA) and some appeared to by sympathetic to the parents in the case.

    Read more:
  • In Europe, Critics Call for Clinical Trial Data Disclosure

    Posted: 14 October 2010

    Doctors writing in the British Medical Journal (BMJ) say regulators and the public are being misled about the effectiveness of some drugs because negative trial results are not published. The researchers from The German Institute for Quality and Efficiency in Health Care are calling for pharmaceutical companies to be forced to publish all clinical data, not just positive results. "Our findings underline the urgent need for mandatory publication of trial data," they wrote in the BMJ. In the US, all data is required to be published.

    Read more:
  • FDA Commissioner Pushes for Emphasis on Regulatory Science

    Posted: 7 October 2010

    The US Food and Drug Administration (FDA) this week unveiled its initiative to advance the field of regulatory science and outlined the agency’s plan in a white paper entitled, Advancing Regulatory Science for Public Health. Commissioner Margaret Hamburg discussed the plan and highlighted the importance of investing in regulatory science during a speech yesterday at the National Press Club in Washington, DC. RAPS expressed its support for FDA’s efforts. “Regulatory science is the important link in the process that helps translate breakthroughs in the laboratory into practical treatments in hospitals, doctors’ offices and peoples’ homes around the country and around the world,” said RAPS Executive Director Sherry Keramidas, PhD, CAE.

    Read more:
  • EMA Promises Guidelines for Biosimilars

    Posted: 7 October 2010

    European Medicines Agency (EMA) Executive Director Thomas Lonngren announced that guidelines on biosimilar monoclonal antibodies will be published in November after review by an expert committee. Once published, the guidelines will be open for public comment for three to six months, making the formal adoption of the guidelines likely in the latter part of next year. The guidelines have been highly anticipated but regulators expect only a handful of biosimilar applications for such products due to the complex nature of biosimilars in comparison to traditional generic pharmaceuticals. Europe, however, is ahead of the US in this area. While US healthcare reform paved the way for biosimilar approvals in the US and FDA plans a public meeting on the topic next month, European regulators have already approved 13 biosimilar medicinal products.

    Read more:
  • Med Device Companies, Consumers Have Different Views on 510(k)

    Posted: 7 October 2010

    Medical device makers and consumer groups submitted comments to the US Food and Drug Administration (FDA) this week on FDA’s 510(k) clearance process, offering very different views of how the premarket review program for low- and moderate-risk devices is currently working. The Advanced Medical Technology Association argues the 510(k) process should be modernized but wholesale changes are not needed. The advocacy group Public Citizen, on the other hand, charges that the system "has failed to keep dangerous and ineffective medical devices from the market."

    Read more:
  • FDA Seeks Public Comment on Five-Year Plan

    Posted: 7 October 2010

    The US Food and Drug Administration (FDA) released its draft five-year strategic priorities plan and is seeking public comments until 1 November 2010. In the plan, FDA identifies four cross-cutting strategic priorities, including advancing regulatory science and innovation, which the agency plans to pursue through its Regulatory Science Initiative, also announced this week. Other priorities identified are strengthening the safety of the global supply chain, strengthening compliance and enforcement and meeting the needs of special populations. The plan outlines strategic program goals related to food safety and nutrition, medical product safety and effectiveness, tobacco regulation and organizational accountability.

    Read more:

September

  • FDA Announces New Clinical Trial Safety Reporting Rule

    Posted: 30 September 2010

    The US Food and Drug Administration (FDA) this week announced its final rule clarifying what safety information must be reported to the agency during clinical trials. The new rule requires companies to report problems such as the occurrence of serious adverse reactions at a higher-than-anticipated rate within 15 days. “This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said an official with FDA’s Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.”

    Read more:
  • EU Parliament Rejects Plan to Allow Drug Info DTC

    Posted: 30 September 2010

    The European Parliament has rejected a proposal to allow pharmaceutical companies to publish information about their medicinal products in print publications aimed at consumers. Members of Parliament’s Environment Committee voted instead to emphasize patients' rights, introducing a new article into the legislation, which requires Member States to ensure that "objective, unbiased information" is publicly available. Critics had called the original proposal from the European Commission "advertising in disguise."

    Read more:
  • NIH, FDA to Award $9.4 Million to Advance Regulatory Science

    Posted: 30 September 2010

    The National Institutes of Health (NIH) announced it will award $9.4 million over the next three years to support four research projects conducted in partnership with the US Food and Drug Administration (FDA) to advance regulatory science. FDA will contribute approximately $950,000. The projects are intended to better inform scientists and regulatory reviewers about medical product safety, and improve the evaluation and availability of new medical products.

    Read more:
  • India Strengthens National Regulatory Capabilities

    Posted: 30 September 2010

    In a move to strengthen India’s national regulatory capabilities, all regional authorities and government laboratories are being electronically linked with the office of the Drugs Controller General of India (DCGI). The networking, which is intended to boost transparency and effectiveness, is expected to be completed by the end of year. The project, being undertaken with the help of WHO, Health Canada and the US Food and Drug Administration (FDA), is part of a major effort to modernize India’s regulatory capacity, which includes restructuring India’s national pharmacovigilance program and revising regulation of medical devices, according to a health ministry official.

    Read more:
  • Clinical Trials Ethics Subject of Debate

    Posted: 23 September 2010

    The marked improvement of cancer patients taking PLX4032, a new melanoma drug in early clinical trials, has prompted some to question the ethics of placing patients in subsequent testing into a control group where they are denied access to the drug. While clinical trials typically use a control group receiving the current standard of care in order to prove the tested drug’s value compared with available treatments, ethics require “genuine scientific uncertainty” about which treatment is better. In the case of PLX4032, the medical community is divided on this point, with some saying further testing with the control group is necessary and others saying the early results are enough to convince them of the drug’s advantage.

    Read more:
  • European Parliament Approves Pharmacovigilance Measures

    Posted: 23 September 2010

    The European Parliament approved the European Commission's (EC) proposal on pharmacovigilance, strengthening EU drug postmarketing surveillance systems and requiring high-risk medicines to display a special black symbol and warning on their packaging alerting patients to the fact that they are “subject to additional monitoring.” It also will require national governments and the EC to establish special websites to provide more information on products and side effects. The measure is the first part of the “pharmaceutical package” of legislation to be adopted. The two other parts concern information offered to patients and measures to reduce counterfeiting.

    Read more:
  • EMA Publishes Review of Orphan Designation

    Posted: 23 September 2010

    The European Medicines Agency (EMA) has published the first of its “review of orphan designation” documents in an effort to increase transparency regarding EMA’s orphan designation process. The documents summarize the review of the orphan designation carried out by the Committee for Orphan Medicinal Products (COMP) for the drug Vpriv, authorized for the treatment of Gaucher disease last month. EMA will continue to make such documents public for future reviews whenever an orphan medicine receives marketing authorization.

    Read more:
  • FDA Plans Public Hearing on Biosimilars

    Posted: 23 September 2010

    The US Food and Drug Administration (FDA) is planning a public hearing in November to examine the development of biosimilar drugs, according to a draft notice of the meeting currently circulating, although the agency has yet to formally announce the meeting. The meeting is the latest indication that FDA is likely in the process of formulating a policy regarding the review and approval of biosimilars in the wake of US healthcare reform legislation that created a US approval pathway for biosimilars for the first time. Despite the legislation, confusion remains among drugmakers, insurers, healthcare providers, investors and others about the specifics of the FDA approval process for such products.

    Read more:
  • FDA Increases Device User Fees; Groups Disagree on Process

    Posted: 16 September 2010

    As the US Food and Drug Administration (FDA) this week announced an 8.5% increase in user fees for medical device companies applying for 510(k) or premarket clearance, industry groups disagree on the effectiveness of the process itself. While medical device trade group AdvaMed released a study showing that of the more than 47,000 products cleared through the 510(k) process since 1998, only a fraction of a percent have been involved in Class I recalls. However, the Medical Imaging & Technology Alliance (MITA) has expressed concern that despite the fees collected under the Medical Device User Fee and Modernization Act, FDA's performance has fallen off as review times have increased in recent years and MITA has raised questions about the agency's ability to keep pace with medical technology.

    Read more:
  • Freer Trade Could Limit Drug Access in Developing Countries

    Posted: 16 September 2010

    New trade agreements set to go into effect between India and the EU could severely limit access to life-saving medicines to treat AIDS and other common illnesses in developing countries, according to a new report. The agreements would impose new patent restrictions on Indian generic drugmakers, which provide many of the more affordable drugs to such areas, likely driving up prices and delaying access to newer, better treatments, says the report from UNITAID, an international organization to promote HIV/AIDS treatment in low-income countries.

    Read more:
  • FDA Advisory Panel Says Cough Meds Should Remain OTC

    Posted: 16 September 2010

    A US Food and Drug Administration (FDA) advisory panel this week concluded by a 15-9 vote that over-the-counter (OTC) cough medicines containing dextromethorphan should not be subject to further restrictions and should not be classified as controlled substances. Such medicines have been increasingly involved in reports of abuse by teenagers and the Drug Enforcement Agency has pushed for tighter restrictions. About 125 currently available OTC cough medicines contain dextromethorphan.

    Read more:
  • EMA, FDA Officially Extend Confidentiality Agreement

    Posted: 16 September 2010

    The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced they have extended indefinitely their confidentiality arrangements related to medicines for human and veterinary use. The agreements, intended to promote greater cooperation and reduce duplicative efforts, were initially signed in 2003. Under the pacts, FDA and EMA agree to exchange confidential information related to scientific advice, orphan drug designation, pediatric development, Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) inspection planning and reports, marketing authorization procedures and postmarketing surveillance.

    Read more:
  • FDA Considers Regulation of Medical Smartphone Apps

    Posted: 9 September 2010

    The US Food and Drug Administration (FDA) is looking into whether to regulate medical smartphone applications that allow anyone to monitor vital signs via popular devices such as the Apple iPhone. While some apps, such as the iStethoscope, do not actually make any medical diagnoses, the line between communications device and medical device appears to be blurring and FDA is taking note. "We are developing draft guidance that will help clarify an appropriate policy and role for the FDA regarding the regulation of mobile applications, including those on smartphones," said an agency spokesperson.

    Read more:
  • EU Restricts Animal Testing

    Posted: 9 September 2010

    The European Parliament has backed new rules limiting the number of animals used in laboratory testing and requiring additional assurances animal welfare is taken into account. Under the new rules, laboratories must get approval from national authorities for animal tests and provide justification for animal use if accepted alternatives exist. The revised directive, intended to support animal welfare without hindering research, replaces EU animal testing rules dating back to 1986 and will go into effect in two years. Animal welfare groups say the new law is not strong enough.

    Read more:
  • Legislation Modernizes Russian Pharmaceutical Market

    Posted: 9 September 2010

    Russia’s "On drug circulation" act, designed to modernize the Russian pharmaceutical industry, bringing it up to European manufacturing quality standards by 2014, became law last week. The legislation, signed in April, creates a unified environment for all drugmakers marketing products in Russia. Under the law, the state will regulate prices for medications classified as critical and health facilities will now be allowed to acquire medicines without distributors. (Editor’s note: The new law and its impact are covered in more detail in the September 2010 issue of Regulatory Focus.)

    Read more:
  • WHO Study: Life-saving Devices Not Available to Poor

    Posted: 9 September 2010

    The World Health Organization (WHO) released the results of its study that found a lack of access to life-saving medical devices in developing countries and called the situation “unfair.” The study also found that revenues from device sales around the world totaled $210 billion in 2008. About four-fifths were earned in the Americas. Findings were released during a forum in Bangkok of Asian health experts to discuss ways to increase access to medical technology in the developing world. “We are holding this forum because the unquestionable benefits of medical devices are so unevenly and unfairly distributed,” said WHO Director General Margaret Chan.

    Read more:
  • Drugmakers Argue Against Disclosure of Possibly Unrelated Adverse Events

    Posted: 2 September 2010

    Trade groups representing drugmakers and biotechnology companies have weighed in on a lawsuit involving disclosure of possibly unrelated adverse events. The suit on behalf of investors alleges that the maker of a popular cold medicine knowingly concealed some reports of the drug’s side effects. The drugmaker and trade groups argue that companies should not be compelled to disclose reports of adverse events that have not been scientifically proven to be related to the use of the medicine in question.

    Read more:
  • DDMAC Enforcement Letters Up; Most Cite Risk Info Problems 

    Posted: 2 September 2010

    Warnings and notices issued by the US Food and Drug Administration’s (FDA) Division of Drug Marketing and Communications (DDMAC) for the first half of this year have increased significantly in comparison to recent years and data show that risk information is one of the most common problems cited. According to an analysis, inadequate risk information was identified most often, followed by overstated efficacy and superiority claims. Despite widespread industry concern over compliance issues for Internet-based promotions, only six of 108 violations involved a website.

    Read more:
  • FDA Launches Public Performance Tracking System

    Posted: 2 September 2010

    The US Food and Drug Administration (FDA) launched its public performance tracking system, FDA-Track, this week. The system will monitor more than 100 FDA program offices through data from key performance measures established each year, according to the agency. Data are expected to be updated quarterly. "FDA-TRACK will bring the operations of this historically opaque agency into the daylight and help us be even more responsive as we work to protect the public health," said FDA Commissioner Margaret Hamburg

    Read more:
  • Irish Medicines Board Limits Product Submission to One Month

    Posted: 2 September 2010

    The Irish Medicines Board (IRB), has announced it will only accept requests to act as the Reference Member State (RMS) in the EU’s Decentralised Procedure for marketing authorization approval during specific one-month periods. The move comes in response to the overwhelming number of requests the IRB has received to act as the RMS. The one-month window for submissions will be open at least once every year, according to the IRB. The window for product filings in the second to fourth quarter of 2011 opened 1 September and will close after the end of the month. The IRB may open additional submission widows depending on the regulator’s capacity to handle such requests.

    Read more:

August

  • Effect of Stem Cell Ruling Unclear, Appeal Planned

    Posted: 26 August 2010

    As the US Department of Justice plans its appeal of the ruling this week barring government funding of stem cell research, the actual effects of the ruling remain unclear. While National Institutes of Health (NIH) Director Francis Collins says he was “stunned” by the ruling and it “has the potential to do serious damage to one of the most promising areas of biomedical research, and just at the time when we were really gaining momentum." The ruling does not directly affect research conducted with private funding, but a number of proposals awaiting NIH review have now been put on hold and a lack of available government funding could have an overall chilling effect on research in the area. One Colorado lawmaker has announced plans to introduce new legislation to allow stem cell research to move forward.

    Read more:
  • More Pediatric Trials Conducted Outside US, Ethics Questioned

    Posted: 26 August 2010

    More pediatric trials are being conducted outside the US, often in poor countries, and the effects on the studied populations are being called into question. According to a new study, 65% of trials conducted under the US Food and Drug Administration’s (FDA) Pediatric Exclusivity Provision are conducted overseas, and 38% of trials included patients in a developing country. The provision, intended to spur development of pediatric medicines, grants drugmakers six months of patent extension in exchange for conducting safety and efficacy studies of their products for children. However, in some cases, patients my have little or no healthcare beyond the trial itself and the resulting drug may never be available or affordable to the studied population.

    Read more:
  • India Concerned About Drugmaker Mergers, Domestic Prices

    Posted: 26 August 2010

    Officials in India are concerned that consolidation among drugmakers could drive prices up for its citizens and is considering steps to ensure needed drugs remain available and affordable. India’s Department of Industrial Policy and Promotion has proposed strengthening compulsory licensing provisions, which would allow Indian drugmakers to make and sell patented medicines in an effort to keep prices for those medicines down and stabilize the supply in the event makers of the original drug raise prices sharply. If granted, the licenses would require royalties be paid to the patent holder.

    Read more:
  • German Pharmacists Say Drug Supply is Safe

    Posted: 26 August 2010

    In the wake of the revelation that counterfeit drugs had entered the legal supply chain through German pharmacies, ABDA, Germany’s pharmacy association, is taking steps to assure consumers that the supply of medicines in Germany is safe. "The safest way to get drugs in Germany is any one of the 21,500 community pharmacies," said an ABDA spokesman, who pointed out that there have been only 40 cases of counterfeiting in Germany's legal supply chain since 1996. ABDA also warns consumers to stay away from illegal or suspicious drug sources available on the Internet or elsewhere.

    Read more:
  • Big Drugmakers Pursue Biosimilars, Start-ups Work on ‘Bio-betters’

    Posted: 19 August 2010

    While a number of large drugmakers proceed with developing biosimilars, despite the lack of official guidance from the US Food and Drug Administration (FDA), some smaller companies are focusing on so-called “bio-betters.” US healthcare reform passed earlier this year created a regulatory pathway for biosimilars and some companies are rushing to be among the first to develop a biosimilar product for the US market. However, the lack of FDA guidance makes this a somewhat risky approach, and others are opting to proceed with the more established regulatory approval pathway for standalone biologic drugs. Bio-betters, which are biologics in the same class as an existing product, but which offer some distinct advantage, are viewed by some as the better opportunity and a number of smaller companies are currently developing such products.

    Read more:
  • Drug Recalls on the Rise

    Posted: 19 August 2010

    The US Food and Drug Administration (FDA) reported more than 1,700 drug recalls in 2009, a dramatic increase from fewer than 500 in 2008; however, an FDA official says the number of recall incidents has not risen. Recall incidents are recalls involving one product problem at a particular company. There were more recalls per incident in 2009 and more than 1,000 of the recalls were attributed to a single company, Advantage Dose, a drug repackager that has since gone out of business. Since so many recalls are being driven by relatively few companies, some say the characterization of the recall rise as a “surge” is a reach, but even if Advantage Dose is removed from the equation, there would still be a 50% increase in recalls, and this has raised concern among some industry observers.

    Read more:
  • Savings From Pay-for-delay Ban Overestimated, Says Report

    Posted: 19 August 2010

    A study funded by the trade group for generic drugmakers contends the Congressional Budget Office (CBO) analysis significantly overstated savings that would be realized from a ban on patent dispute settlements that keep generic medicines off the market longer. The Federal Trade Commission (FTC) has called for an end to such “pay-for-delay” deals in which brand-name drugmakers pay to delay the launch of generic competitors, and a CBO analysis provided support for the argument that the ban would save consumers and government money. The report charges the CBO and FTC used “faulty assumptions,” specifically, they were wrong to assume that banning these types of patent settlements would speed up generic entry into the marketplace by 17 months.

    Read more:
  • China, Germany Take Action Against Counterfeit Medicines

    Posted: 19 August 2010

    China's State Food and Drug Administration is working with provincial and national authorities to investigate and eradicate 33 counterfeit medicines currently in circulation. At the same time, German authorities are pursuing action against regional pharmacies suspected of purchasing and distributing cheap, illegal active ingredients used to manufacture in-house cancer treatments being sold to the general public. While China appears to be taking steps to improve its spotty reputation for pharmaceutical quality, the incident in Germany is relatively rare and has sparked concern about fakes entering the legal supply chain there.

    Read more:
  • Regulatory Pros More Involved in Business, Compensation Up

    Posted: 12 August 2010

    RAPS’ 2010 Scope of Practice & Compensation Report for the Regulatory Profession shows regulatory professionals are taking on a wider range of responsibilities, including business functions, and overall compensation continued on an upward trend, although it grew at a slightly slower pace. Also noteworthy among the findings is that RAC-certified professionals in the US reported compensation that is 6% higher than their non-RAC peers. The report was compiled from the results of a global survey of more than 3,000 regulatory professionals from 55 different countries.

    Read more:
  • FDA Cites Drugmaker for Facebook Promo

    Posted: 12 August 2010

    The US Food and Drug Administration (FDA) this week cited drugmaker Novartis for its use of a Facebook widget that the agency says failed to adhere to risk disclosure rules. The widget allows users to share links to sites they like with their Facebook friends. When the link is created, the widget adds a short description which in this case included efficacy claims for the drug Tasigna, but no risk information associated with the drug’s use. This is likely the first time FDA has issued such a warning in relation to a Facebook promotion.

    Read more:
  • EMA, FDA Seeking Participants for Pilot GMP Program

    Posted: 12 August 2010

    The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have teamed up for a joint Good Manufacturing Practices (GMP) inspection pilot program. The agencies are seeking manufacturers of medicinal products to participate in the pilot to determine whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication of inspections.

    Read more:
  • US Senate Bill Would Create Incentives for Pediatric Drugs

    Posted: 12 August 2010

    Last week, a new bipartisan bill intended to spur research on drugs for rare and neglected pediatric diseases was introduced in the US Senate. The Creating Hope Act would amend existing law, offering drugmakers priority review for another drug within six months in exchange for developing such a pediatric medicine that might not otherwise receive sufficient research and development funding.

    Read more:
  • FDA Proposal Would Dramatically Change 510(k) Process

    Posted: 5 August 2010

    The US Food and Drug Administration (FDA) this week issued its proposed changes to the 510(k) approval process for medical devices. The long-awaited recommendations would dramatically change the review and approval process by creating a new class of devices, requiring additional information from sponsors and leveraging more expertise from outside FDA, among other things. The proposal attempts to address lingering questions about the 510(k) process and comes nearly a year after FDA’s Center for Devices and Radiological Health (CDRH) was sharply criticized amid controversy over safety recalls and internal division.

    Read more:
  • Drug Safety Bill Introduced in US Senate

    Posted: 5 August 2010

    A bill aimed at strengthening drug safety requirements that would grant the US Food and Drug Administration (FDA) additional authority was introduced in the US Senate this week. The bill would give FDA recall authority over drugs, rather than having the agency rely on voluntary manufacturer recalls. It also would give FDA subpoena powers, enhance the agency’s ability to track manufacturers outside the US that supply products for the US market and require more comprehensive documentation of drugmakers’ subcontractors.

    Read more:
  • India Increases Scrutiny of Clinical Trials, Biotech, Devices

    Posted: 5 August 2010

    The Drugs Controller General of India (DCGI), the country’s top health regulatory authority, has begun to enforce tougher approval standards for clinical trials and marketing licenses for biotechnology drugs, medical devices and vaccines in India. A number of vaccine marketing approval applications from large, big-name drugmakers were returned recently with deficiency letters attached, and sponsors have complained about long delays and sudden “bureaucratic” hurdles. A DCGI official has said the delays are the result of incomplete applications, and a senior health ministry official indicated that past approval standards for biotechnology products were not rigorous enough.

    Read more:
  • New Zealand Vows to Improve Drug Access

    Posted: 5 August 2010

    After ranking last among 14 nations in access to medicines, New Zealand officials have pledged improved access to drugs not funded through the country’s Pharmaceutical Schedule. New Zealand will review its three Exceptional Circumstances (EC) schemes overseen by Pharmac, the nation’s pharmaceutical management agency, with the goal of providing better access to medicines that are not funded through the Schedule, according to Health Minister Tony Ryall. Under the three EC schemes, Pharmac receives more than 3,000 applications each year from patients suffering from rare or difficult-to-treat conditions. "The Government is determined to see New Zealanders get better access to medicines, and I will be interested to see the feedback from consumers, as well as the health and pharmaceutical sectors," said Ryall.

    Read more:

July

  • FDA AdComm Rejects Opioid Class REMS

    Posted: 29 July 2010

    A US Food and Drug Administration (FDA) advisory committee has rejected the agency's proposed classwide opioid risk evaluation and mitigation strategy (REMS), saying the REMS did not do enough to prevent misuse and abuse. Committee members took issue with FDA's decision not to include mandatory physician training and patient registration as part of the REMS and to have the program apply only to extended-release opioids. FDA usually abides by the advice of its advisory committees.

    Read more:
  • More Suspect Medicines Seized in EU

    Posted: 29 July 2010

    Annual increases in seizures of medicines suspected of infringing intellectual property have led the EU to pay more attention to the problem. Medicines now total 10% of all articles seized, up from 2.1% in 2006. This growth has seen the number of medicine articles seized by EU customs officials increase from 2.7 million in 2006 to 11.5 million in 2009. The number of cases registered 2009 rose slightly over 2008, from 3,207 to 3,368.

    Read more:
  • US Senate Drops Pay-for-Delay Ban

    Posted: 29 July 2010

    The US Senate has thrown out a legislative proposal to ban the “pay-for-delay” agreements between brand-name and generic drugmakers that was recently approved by the US House of Representatives. The measure was part of the War Funding Bill, which also included billions of dollars to fund a range of unrelated domestic spending measures, one of which was the ban on payments between branded and generic drugmakers that aim to delay generic competition to patent-expired innovative drugs.

    Read more:
  • Increased Biotech Funding in Israel

    Posted: 29 July 2010

    The Israeli government has established a $250 (US) million biotechnology fund to rejuvenate the nation’s innovative drug development sector, but the local drugmaking sector is still in need of investment, says a recent report. Israel’s Teva Pharmaceutical Industries is the world’s largest generics maker and has also successfully developed and marketed its own patented medicines, but smaller, research-based ventures have had to use multinational firms as commercial partners due to their lack of marketing experience, according to the study, from Business Monitor International (BMI).

    Read more:
  • Critics of Biosimilar Pathway Call for Clinical Trials

    Posted: 22 July 2010

    Medical experts and critics of the biosimilar approval pathway created by the US healthcare reform law this week called for mandatory clinical trials for biosimilar drugs. They warned that allowing such medicines onto the marketplace without trials could lead to compromised safety and effectiveness, and said the law gives the US Food and Drug Administration (FDA) too much leeway to determine whether clinical trials are necessary. Rep. Anna Eshoo (D-CA), who sponsored the biosimilars provision, countered "The FDA has both the responsibility and the expertise to determine a drug’s safety and efficacy—not drug companies, insurance companies, or members of Congress. As technology evolves, the FDA must have the flexibility to determine the most effective ways to test biologics."

    Read more:
  • FDA Advisory Committee Members Support REMS 

    Posted: 22 July 2010

    Members of advisory committees to the US Food and Drug Administration seem to have embraced REMS (Risk Evaluation and Mitigation Strategies) as an alternative to pulling certain drugs from the market or keeping them off the market in the first place. In instances such as the recent advisory committee hearing on controversial diabetes drug Avandia, a number of committee members have indicated that the strict postmarketing controls that can be part of REMS gives regulators the ability to allow a drug to be available to the patients who may benefit from it, while restricting its use by others and keeping track of safety issues.

    Read more:
  • Europe to Provide 6.4 Billion Euros for Research

    Posted: 22 July 2010

    The European Commission announced it will provide 6.4 billion euros in funding to boost science research and innovation. Health researchers will receive more than 600 million euros, and more than 1.3 billion euros have been earmarked for “the best creative scientists selected by the European Research Council.” The funding is part of the European Union’s new “Innovation Union Flagship” project and is expected to both encourage scientific innovation, foster a more competitive and sustainable Europe over the long term and create more than 165,000 new jobs.

    Read more:
  • Debate Continues Over Regulation of Consumer DNA Tests

    Posted: 22 July 2010

    Amid increasing debate over the validity and availability of genetic tests marketed directly to consumers (DTC), the US Food and Drug Administration (FDA) held a public meeting this week on laboratory developed tests, which included discussion of the proliferating DTC tests. Critics say some companies marketing the tests make broad, unsubstantiated claims, and test results may be too complex or simply unreliable. A panel of experts convened by FDA agreed that the tests carry different risks to the public than other, existing over-the-counter tests for things such as pregnancy or cholesterol. However, test makers and others argue the federal government should not restrict public access to genetic information.

    Read more:
  • Increasing FDA/EMA Cooperation Focuses on Specific Topics

    Posted: 15 July 2010

    Officials at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) say the agencies are increasingly sharing confidential information, using topic-specific groups to facilitate dialogue. Topic groups or “clusters” cover key areas including oncology, vaccines, orphan drugs, pediatrics, pharmacogenomics and veterinary products, and more may be added. The two agencies have had a formal information-sharing agreement in place since 2003 under which they share information and data related to new and pending applications. Approval decisions have remained independent. The agencies are expected to renew their agreement this September.

    Read more:
  • FDA Advisory Panel Delivers Mixed Vote on Avandia

    Posted: 15 July 2010

    A US Food and Drug Administration (FDA) advisory panel yesterday delivered a mixed vote on the diabetes drug Avanida, with most voting to either severely restrict usage or remove the drug from the market, because of increased risk of heart attack. Of the 33 panel members, 12 voted to withdraw the medication, 10 voted for restrictions, seven voted to add warnings and three voted allow continued marketing with no changes. One abstained. While FDA generally follows panel advice, this mixed verdict leaves the agency with a less clear recommendation, and the ultimate decision will be watched closely in light of Commissioner Margaret Hamburg’s stated commitment to drug safety and science-based decisions. Regulators in Europe and India are also taking another look at the drug.

    Read more:
  • India Could Make Cheaper HPV Vaccine Without Patent Violation

    Posted: 15 July 2010

    A new study indicates vaccine manufacturers in India and other developing countries may be able to produce cheaper versions of the vaccine for human papilloma virus (HPV) without infringing on existing patents. Researchers examined the complex array of patent protections related to the HPV vaccine and found that only 19 of the 86 patented technologies were patented in India. This is significant news for protecting against cervical cancer in India and other developing nations where the $300 price tag for brand-name Gardasil is beyond the means of most potential patients.

    Read more:
  • Biomarkers Could Lead to Alzheimer’s Breakthroughs

    Posted: 15 July 2010

    New biomarkers developed to diagnose Alzheimer's much earlier in the disease’s progression are likely to transform the entire approach to the disease and could lead to innovative new treatments. The biomarkers were developed and tested by expert panels convened by the National Institute on Aging and the Alzheimer’s Association. Diagnosis of Alzheimer’s has traditionally come at the onset of dementia, which is now viewed as a late stage in the progression of the disease. Experts now believe Alzheimer’s is present in patients a decade or more before they exhibit symptoms. The new biomarkers will make it possible to detect it at earlier stages through tests such as brain scans, MRIs and spinal taps.

    Read more:
  • High Costs Limit Biosimilars Development

    Posted: 8 July 2010

    While regulatory approval pathways are now in place for biosimilars, high R&D costs, complexity of production and legal issues continue to limit the number of companies able to enter the market. With total costs to develop, manufacture and market a biosimilar version of an established biologic drug around 50 times higher than the cost for a traditional generic, analysts say only five or six large companies will be capable of playing a role. Smaller companies, they say, won’t be involved at all.

    Read more:
  • Pay-for-Delay Deals Decline in Europe

    Posted: 8 July 2010

    The European Commission (EC) is reporting a decrease in pharmaceutical patent settlements that may violate European antitrust laws. In the 18 months from 1 July 2008 to 31 December 2009, only about 10% of the 93 settlement agreements were reached between originator companies and generic drugmakers, compared with 22% of the 207 deals during the previous seven and a half years (January 2000 to June 2008). The EC has been keeping a close watch on so-called pay-for-delay deals over the past few years, including launching a series of raids and an antitrust probe that ended last summer.

    Read more:
  • Devices Transmitting Data Pose Security Risks

    Posted: 8 July 2010

    Pacemakers and other medical devices that transmit health data wirelessly may expose private medical information to unauthorized individuals or possibly even interfere with treatments, according to members of the Medical Device Security Center. The wireless data transmission is intended make regular monitoring easier, allowing healthcare professionals to get feedback and adjust therapies accordingly. “These devices do increase the effectiveness of patient care,’’ said Kevin Fu, a director of the center. “The two main risks are access to private information and control of the device. Security and privacy have much room to improve for medical devices.’’

    Read more:
  • US Drug Prices Comparable to Europe, Says Study

    Posted: 8 July 2010

    Researchers at the London School of Economics argue in a new report that differences in prices for brand name drugs in the US and Europe are very small and the modest gap is continuing to narrow over time. The report undermines claims by the US pharmaceutical industry that drug research and development is disproportionately supported by US consumers paying higher prices than their European counterparts. The research team conducted a rigorous drug-by-drug comparison and their findings will be published in an upcoming article in Health Economics, Policy and Law.

    Read more:
  • FDA, CMS Cooperation Could Lead to Parallel Reviews

    Posted: 1 July 2010

    The US Food and Drug Administration (FDA) and US Centers for Medicare & Medicaid Services (CMS) agreed last week to share confidential data on device approval submissions, a possible first step toward parallel reviews that could result in simultaneous approvals by both agencies. CDRH head Jeffrey Shuren said the two agencies could eventually define circumstances under which FDA approval of a device would allow CMS to approve reimbursement without requiring additional evidence. The agreement will take effect next month.

    Read more:
  • FDA Issues Guidance on Studies for IVD Applications

    Posted: 1 July 2010

    The US Food and Drug Administration (FDA) issued its final guidance on studies supporting premarket applications for in vitro diagnostic (IVD) devices. The guidance document is presented in Q&A format and is intended to address frequently asked questions device makers have about developing and conducting IVD studies, and covers important data considerations for such studies. The original draft guidance was issued in October 2007.

    Read more:
  • Germany to Require Drugmakers to Negotiate Price

    Posted: 1 July 2010

    German Chancellor Angela Merkel’s Cabinet approved legislation this week that would compel drugmakers and health insurers to negotiate prices of new drugs, taking into account cost-effectiveness. The proposal would give drug companies the power to set a drug price unilaterally only if an agreement is not reached after 15 months. The bill, which in intended to save 2 billion euros per year on patented medicines, will now head to the Bundestag, the lower house of the German parliament for its approval.

    Read more:
  • Drug R&D Less Productive, Says Report

    Posted: 1 July 2010

    New drugs are making up an increasingly smaller portion of overall pharmaceutical sales, according to the 2010 Pharmaceutical R&D Factbook, released this week by CMR International. Drugs launched within the last five years represented less than 7% of global pharmaceutical sales in 2009, a drop from the 8% reported in 2008. As a result of the lack of research and development (R&D) productivity, many large drugmakers have begun to cut back on R&D operations. Total expenditures for R&D were down 0.3% in 2009, after a 6.6% increase the previous year and rapid growth in earlier years.

    Read more:

June

  • Report Raises Concerns Over FDA Monitoring of Foreign Trials

    Posted: 24 June 2010

    The US Department of Health and Human Services issued a report this week highlighting concerns about the number of clinical trials conducted outside the US and the US Food and Drug Administration’s (FDA) capacity to monitor such trials. According the report, 80% of drugs approved for US sale in 2008 were supported by foreign trials while FDA inspected just 0.7% of foreign clinical trial sites. The report encourages FDA to pursue more cooperation with foreign governments and explore “new models of oversight.” The European Medicines Agency recently issued a reflection paper on foreign trials with similar findings and recommendations.

    Read more:
  • EFPIA President Supports CER Role for EMA

    Posted: 24 June 2010

    The president of the European Federation of Pharmaceutical Industries and Associations (EFPIA) said this week he supports a greater role for the European Medicines Agency (EMA) in establishing the effectiveness of approved drugs, rather than leaving it to national authorities such as the UK’s National Institute for Clinical Excellence (NICE). Andrew Witty, who is also CEO of GlaxoSmithKline, said "There is a certain degree of appeal to having a rational evidence-based relative efficacy or effectiveness discussion once in Europe rather than having it 27 times and potentially answered 27 different ways.”

    Read more:
  • FDA Urges Drugmakers to Explore Drugs for Rare Diseases

    Posted: 24 June 2010

    The US Food and Drug Administration (FDA) is encouraging drugmakers to explore whether existing, approved medicines may help treat neglected disorders. This comes after an FDA incentive program did not result in research on new therapies as agency officials had hoped. To spur action by drugmakers, FDA published a list of 235 approved treatments that could possibly benefit patients with rare disorders and already have marketing clearance for other uses.

    Read more:
  • CDRH Chief Says 510(k) Changes Coming Soon

    Posted: 24 June 2010

    According to Director of the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, the results of the agency's comprehensive review of its 510(k) clearance program will be out in a few weeks. Shuren told the audience at the latest in a series of "town hall" meetings held near Boston this week that CDRH would seek public comments before implementing any changes to the program. He did not say what changes would be recommended. "What we’ve been saying so far is not anything about what changes we’re going to make,” said Shuren. "The only thing I’m very clear about is we’re not recommending to get rid of the 510(k) program."

    Read more:
  • FDA Proposes Tougher Regulation of Outsourcing

    Posted: 17 June 2010

    The US Food and Drug Administration (FDA) may begin holding pharmaceutical companies more accountable for outsourced manufacturing operations, including requiring drugmakers to conduct inspections of their contractors' facilities instead of relying solely on reported data. FDA is also considering issuing warning letters to both drugmakers and their contractors when manufacturing problems are found instead of just sending them to the contractors.

    Read more:
  • Rise in Drug-Resistant Diseases Requires Action

    Posted: 17 June 2010

    A negative side effect of efforts to distribute lifesaving drugs in developing countries is an increase in drug-resistant diseases, and coordinated, global action is necessary to combat the problem, says a new report. The report from the Center for Global Development found that drug resistance is being driven in many countries by drug misuse and weak healthcare systems. While some countries have made attempts to overcome the problem, the report calls for a “systemic global response.”

    Read more:
  • NIH, FDA Coordinate Efforts to Support Personalized Medicine

    Posted: 17 June 2010

    Writing in the New England Journal of Medicine, the heads of the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) laid out their plans to help to expedite the development of gene-therapy drugs and diagnostics for personalized medicine. In their commentary, FDA Commissioner Margaret Hamburg and NIH Director Francis Collins committed their agencies to investing in efforts to establish a clear regulatory path for both drugs and diagnostics that encourages innovation while ensuring patient safety.

    Read more:
  • India to Require Regulatory Checks of Devices

    Posted: 17 June 2010

    The Indian government will begin requiring regulatory checks of all medical devices marketed in the country under a comprehensive amendment to current drug law. Historically, only the few devices categorized as drugs in India have been required to be registered with the Drugs Controller General of India (DCGI) and subject to regulation. However, with the new legislation, medical device manufacturers and importers will have to register all devices with DCGI.

    Read more:
  • Report Urges Changes at FDA

    Posted: 10 June 2010

    A report from the Institute of Medicine and the National Research Council says the US Food and Drug Administration (FDA) is ill equipped to handle food supply problems. Among other things, the report urges FDA to proactively focus on identifying and addressing high-risk areas to prevent outbreaks of foodborne illnesses. It also recommends giving the agency the authority to issue mandatory recalls of food products and to delegate responsibility for inspections to states. Many of the recommendations in the report would be met under food safety legislation passed last year by the House. The Senate has yet to act on its bill.

    Read more:
  • EU Drugmakers Anticipate Parallel Trade

    Posted: 10 June 2010

    In the wake of medicine price cuts in Greece last month, EU drugmakers are anticipating an increase in parallel trade. Parallel trade allows pharmacists, distributors and other traders to buy lower-priced drugs in one country and sell them elsewhere at a markup that is still below established prices in higher-cost Member States. “The Greek prices would be lossmaking and our medicines would travel to other markets in a completely uncontrolled fashion,” said Lars Sorensen, chief executive of Novo Nordisk.

    Read more:
  • WHO DG Denies Industry Influence on Flu Guidance

    Posted: 10 June 2010

    A report from the Council of Europe criticized the World Health Organization (WHO) and EU agencies and governments for their handling of the H1N1 flu pandemic. This followed a joint investigation by the British Medical Journal (BMJ) and The Bureau of Investigative Journalism recently published in BMJ. That investigation reported researchers advising WHO over preparations for the pandemic had worked for drugmakers “who stood to gain from the guidance these scientists were preparing.” Dr. Margaret Chan, WHO director-general, responding to the BMJ article in writing, stated, “At no time, not for one second, did commercial interests enter my decision making.”

    Read more:
  • Fighting Cancer With Nanoparticles

    Posted: 10 June 2010

    Scientists at the Scripps Research Institute are using glycoproteins paired with nanoprticle liposomes loaded with doxorubicin to target and destroy one type of cancerous cell. Professor James Paulson and his team are targeting B cells, and hope their findings may lead to new therapies to treat lymphomas, leukemia and related cancers. “We are very interested in moving this technology forward to see if it would be applicable to treatment of humans and to investigate other applications for this kind of targeting,” said Paulson.

    Read more:
  • More Biologics Manufacturing to be Outsourced

    Posted: 3 June 2010

    Large pharmaceutical companies will increasingly outsource production of biologics, helping reduce costs and speed development, says a new report. While drugmakers have traditionally avoided outsourcing of biologics manufacturing, contract manufacturing organizations (CMO) have increased their biologics expertise and capabilities in recent years, helping allay the regulatory and quality concerns that have led drugmakers to keep biologics manufacturing operations largely in-house until recently.

    Read more:
  • US Congress Broadens Probe of J&J

    Posted: 3 June 2010

    Johnson & Johnson is under increased scrutiny as the US Congress has broadened its investigation of the company after allegations of a “phantom recall” of Motrin IB packets came to light. Congress had been looking into J&J’s recent recall of more than 130 million bottles of children’s medicine when it was revealed that in 2008, the company’s McNeil unit hired contractors to buy stocks of Motrin packets that had a possibility of reduced potency. Contractors were reportedly instructed to act like regular consumers. J&J contends purchases were made for the purpose of conducting tests to determine whether a recall would be necessary. The investigating committee has asked for all records related to the incident.

    Read more:
  • US Supreme Court Considers Generic Preemption Case

    Posted: 3 June 2010

    This week, the US Supreme Court asked the Obama administration for its views on whether generic drug companies can be sued in state courts for allegedly inadequate labeling. Generic drugmakers argue that federal law preempts state law, providing immunity from such lawsuits. The case involves a woman who says she developed a severe neurological movement disorder after taking a generic version of a heartburn drug. The appeal comes after an Eighth Circuit Court decision in November found that the limits on preemption established in 2008’s Wyeth v. Levine case also extend to generics makers.

    Read more:
  • EMA Addresses Ethics, GCPs of Trials Outside Europe

    Posted: 3 June 2010

    The European Medicines Agency (EMA) recently released a reflection paper addressing ethical and Good Clinical Practice (GCP) issues related to clinical trials conducted in countries that do not belong to the EU or the European Economic Area. Drug marketing applications submitted in Europe increasingly include data from non-European clinical trials, which are difficult for European authorities to directly monitor. The paper addresses this challenge and calls for increased cooperation and communication between international regulatory authorities. EMA will be accepting comments on the paper through 30 September 2010.

    Read more:

May

  • As NICE Recommends First Biosimilar, US Pathway Questioned

    Posted: 27 May 2010

    The UK’s National Institute for Health and Clinical Excellence (NICE) issued its first recommendation for a biosimilar product this week, while in the US, questions have arisen about the usefulness of the new biosimilar approval pathway itself. NICE gave its approval—based on cost effectiveness—to a biosimilar product already approved by the European Medicines Agency as safe and effective, to treat growth deficiencies in children. Meanwhile, some are casting doubt upon the usefulness of the new biosimilar approval pathway created by the US healthcare reform law, citing several advantages of a conventional Biologics License Application over the new pathway.

    Read more:
  • FDA, NIH Launch Safety Reporting Website

    Posted: 27 May 2010

    The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched a new website allowing users to report safety problems related to food (including animal feed), veterinary drugs and human gene transfer trials. Eventually, the portal will allow reports for other types of clinical trials and safety issues for products regulated by other federal agencies, according to an FDA statement. “The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said FDA Commissioner Margaret Hamburg.

    Read more:
  • FTC Chief Promises Action on Pay-for-Delay Deals

    Posted: 27 May 2010

    Stopping “pay-for-delay” deals where a brand-name drugmaker pays to delay introduction of a generic version is one of the US Federal Trade Commission’s (FTC) highest priorities, FTC Chairman Jon Leibowitz told a Senate subcommittee. Such deals cause “enormous consumer harm,” said Leibowtz, limiting competition and raising costs for American consumers, businesses and government. It is estimated that pay-for-delay deals cost the American public $3.5 billion or more per year.

    Read more:
  • Innovative Stem Cell Project Offers Hope for Motor Neuron Disease

    Posted: 27 May 2010

    British scientists have launched a groundbreaking project using stem cells to recreate and study a devastating and incurable neurological disease in the laboratory. Researchers in London and New York will create stem cells carrying a genetic mutation responsible for motor neuron disease (MND) and observe how the disease kills off healthy nerve cells and spreads. It is nearly impossible to study MND this way in living patients and the hope is that this research will provide previously impossible insight into a disease that currently has few effective treatment options. The most common form of MND is amyotrophic lateral sclerosis (ALS), also known as or Lou Gehrig’s disease.

    Read more:
  • FDA Proposes New Disclosure Rules

    Posted: 20 May 2010

    The US Food and Drug Administration’s (FDA) Transparency Task Force released 21 draft proposals this week that would disclose more information to the public about such things as drug rejections, plant inspections and detailed side-effect reports. The proposed disclosure policies are part of the second phase of FDA’s transparency initiative intended to increase public understanding of how the agency operates and makes decisions. FDA will be accepting public comments on the proposals until 20 July.

    Read more:
  • India, Thailand Ask WHO to Stay Out of Intellectual Property

    Posted: 20 May 2010

    India and Thailand have called upon the World Health Organization (WHO) to focus its efforts on improving access to safe, effective and affordable medicines in the developing world, not protecting drugmakers’ intellectual property. The nations are asking WHO to end its involvement in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which critics say has conflicts of interest and is being manipulated to protect intellectual property rights.

    Read more:
  • CDRH Chief Hears From Stakeholders at Town Hall Meeting

    Posted: 20 May 2010

    Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), met with members of the medical technology community in Minnesota this week in a town hall meeting. Many of the estimated 400 attendees politely criticized what they see as the shortcomings of the FDA device approval process, including lack of predictability, bloated timelines and unprepared, unresponsive agency staff. Shuren addressed the 510(k) review program, saying that the program would continue but that changes would be announced in a few weeks.

    Read more:
  • Spain to Impose Drug Price Cuts

    Posted: 20 May 2010

    In an effort to rein in its massive budget deficit, Spain will cut the prices of a wide range of patented prescription drugs, which officials say will save the country around 1.3 billion euros. Industry critics say the measure will severely damage Spain’s pharmaceutical industry, putting 20,000 jobs in jeopardy. An industry group spokesman said medicine prices in Spain are already 23% below the EU average, and suggested raising copayments as an alternative measure. Drugs currently make up 32% of Spain’s total healthcare expenditures.

    Read more:
  • FDA Encourages Docs to Report Misleading Drug Promos

    Posted: 13 May 2010

    The US Food and Drug Administration (FDA) this week launched a program to encourage doctors to report misleading pitches from pharmaceutical salespeople in the field. The effort, dubbed the “Bad Ad Program” by FDA, will begin with agency representatives engaging healthcare providers at select medical conventions and partnering with medical organizations to educate doctors on how to spot the questionable practices. FDA staffers check print and broadcast advertising and medical journals for misleading material, but until now have been unable to monitor face-to-face interaction between doctors and drug company representatives.

    Read more:
  • EMA, FDA, Drugmakers, Academics Team Up on Drug Tests

    Posted: 13 May 2010

    An unprecedented collaboration between the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), scientists at 17 companies and academic researchers could streamline the drug testing and approval process. The project, called the Predictive Safety Testing Consortium, aims to find simple measures that will indicate whether a drug is likely to cause serious side effects, and then share the information among drug developers and regulators. As its first project, the group chose a panel of biomarkers to predict kidney injury from experimental drugs.

    Read more:
  • Drugmakers Must Be Cautious In Use of Unbranded Websites

    Posted: 13 May 2010

    Some drugmakers and other healthcare product companies have begun to explore the use of unbranded websites to engage consumers around specific diseases or health issues. A recent report looks at this approach as a possible way to engage with patients in a more relatable way as part of a company’s relationship marketing strategy. At the same time, the US Food and Drug Administration (FDA) recently sent a Warning Letter to a large drugmaker over company-operated educational websites, and the agency is feeling pressure from consumer groups to monitor stealth marketing efforts designed to eavesdrop and analyze conversations by and among health consumers.

    Read more:
  • EMA Urged to Release Adverse Reaction Reports

    Posted: 13 May 2010

    The European Ombudsman vehemently disagrees with the European Medicines Agency’s (EMA) insistence that EU transparency rules do not apply to adverse drug reaction (ADR) reports and has urged the agency to release documents relating to possible ADRs. The case in question concerns an Irish citizen who requested reports of possible ADRs from a nationally authorized acne drug more than two years ago. EMA refused to allow access, arguing that transparency laws are not applicable. Reported reactions include a potential increased risk of suicidal tendencies in patients taking the drug.

    Read more:
  • Biosimilar Pathway a Priority for FDA

    Posted: 6 May 2010

    The US Food and Drug Administration (FDA) will convene a work group to establish the approval pathway for biosimilars, and the agency plans to issue guidance on the topic, according to Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER). The recently passed US healthcare reform legislation contains provisions to allow FDA to approve biosimilars. “People want to understand the pathway”, said Woodcock. “We're open for business but realize many people will need more guidance on how to have biosimilars approved.”

    Read more:
  • EU and US Medical Device Regulation Reexamined

    Posted: 6 May 2010

    As medical devices have become increasingly complex and usage has grown, both EU and US device regulations are being reexamined and reconsidered. The EU recently revised its device regulatory system, which had been unchanged since 1998. The revisions came into force in March. US regulations under the US Food and Drug Administration (FDA) have been revised periodically since their 1976 creation, but the entire system is currently being reviewed by FDA in cooperation with the Institutes of Medicine (IOM) of the National Academies, and may be overhauled.

    Read more:
  • RAPS Partners With Chinese University to Develop Courses

    Posted: 6 May 2010

    RAPS has entered into an agreement with the University of Shanghai for Science and Technology (USST) to work collaboratively in developing regulatory education content for the university. RAPS will provide some of the existing online course content currently offered through its Online University, which will be adapted for USST’s students, as well as guide the university in developing new regulatory curricula and provide advice and support to university faculty. The focus initially will be on medical devices, but could expand to cover pharmaceutical or other medical products in the future.

    Read more:
  • FDA Announces Latest Safety Investigations

    Posted: 6 May 2010

    The US Food and Drug Administration (FDA) released its quarterly list of adverse event safety investigations covering the period from October through December 2009. Among the issues FDA is looking into are reports of liver toxicity in patients using a drug to prevent HIV infection after exposure to the AIDS virus, and cases of male breast cancer in patients treated with certain prostate and baldness drugs. A product’s inclusion on the list means FDA has identified a potential safety issue, but not that it has established a causal relationship between the drug and the listed risk.

    Read more:

April

  • China’s Healthcare Reform Presents Opportunities

    Posted: 29 April 2010

    As China undergoes sweeping, unprecedented changes to its antiquated healthcare system, opportunities for Chinese and foreign healthcare companies are beginning to emerge. The government has put more than $586 billion (US) into an economic stimulus package to upgrade infrastructure and boost social welfare, and devoted another $124 billion to healthcare reform. Observers say the medical device market there could be poised for strong growth, and Chinese regulations are being modified to make the country a more attractive place for clinical trials.

    Read more:
  • EU to Overhaul Clinical Trials Directive

    Posted: 29 April 2010

    The EU executive is planning a major overhaul of its Clinical Trials Directive, which is widely viewed as a hindrance to clinical trials, adding costs and bureaucracy. The European Commission plans to fix the flawed directive by October 2011. However, officials are unsure if they simply need to clarify elements of the existing directive or craft a brand new regulation that would better address the existing rule's inconsistencies.

    Read more:
  • EMA Committees Overwhelmed, Says Report

    Posted: 29 April 2010

    The two main committees driving regulation by the European Medicines Agency (EMA) are “overwhelmed with work,” according to a new report on the agency. The workloads of EMA’s Committee for Medicinal Products for Human Use (CHMP) and its counterpart for veterinary drugs (CVMP) are just about at maximum capacity, says the report from Ernst & Young. It recommends setting up two dedicated committees to deal with referrals and generics, respectively. The mostly positive report is the result of a year-long evaluation.

    Read more:
  • FDA Chief Stresses Collaboration With USP on Monographs

    Posted: 29 April 2010

    The US Food and Drug Administration (FDA) and the US Pharmacopeia (USP) need to work in ongoing, close collaboration on the modification of monographs in order to prevent contaminated products from entering the healthcare system, said FDA Commissioner Margaret Hamburg. The need to remain vigilant against the threat of counterfeit or adulterated products was illustrated by the Heparin contamination crisis two years ago.

    Read more:
  • Biotech Awaits Impact of US Healthcare Reform

    Posted: 22 April 2010

    While it is too early to declare whether US healthcare reform will be a net positive for the biotechnology industry, it is certain to have a profound impact. Passage of the Patient Protection and Affordable Care Act creates for the first time a detailed approval pathway for biosimilars in the US. It also establishes new fees for brand-name drugs and new taxes on medical devices. There are so many variables at play, analysts and biotech executives alike appear to be taking a ‘wait and see’ approach as to its ultimate effects.

    Read more:
  • EU Price Controls, Expiring Patents to Hinder Drug Sales

    Posted: 22 April 2010

    The worldwide sales growth of pharmaceuticals is expected to slow this year because of expiring patents and a move to tighter price controls in Europe. A new report from a healthcare industry research company estimates global prescription drug sales growth to be between 4–6% compared with 7% in 2009. Drugmakers have been unable to replace blockbuster drugs developed in the 1990s with similarly profitable new, innovative products.

    Read more:
  • Nigeria, China to Work Together to Battle Counterfeit Drugs

    Posted: 22 April 2010

    Representatives from Nigeria's health authorities recently traveled to China to meet with Chinese leaders to discuss ways to better combat drug counterfeiting and support Nigerians’ access to authentic, good-quality drugs. The working visit represents a proactive step in addressing the growing influx of fake drugs. Several Chinese companies have been identified as sources. A similar trip to India is also planned.

    Read more:
  • Heart Device Failure Case Raises Accountability Questions

    Posted: 22 April 2010

    Two Minneapolis cardiologists have raised a fundamental question about medical device safety and who should be held accountable when a company sells a flawed, dangerous product. In such cases, companies often strike plea deals and end up paying a significant fine, but company officials typically do not face criminal prosecution. The two doctors are calling for greater personal responsibility in such cases by those who run the companies.

    Read more:
  • Researchers Reexamining Hallucinogens

    Posted: 15 April 2010

    Researchers are taking another look at possible therapeutic uses for hallucinogens, a category of drugs that has been off limits to mainstream medicine since the 1960s. Researchers believe certain hallucinogens can be used to treat a number of psychiatric conditions and regulators are once again granting approval for controlled experiments using rigorous protocols and safeguards. Despite this, little money is yet available to support such research.

    Read more:
  • FDA Approval Causes Price Hike for Old Treatment

    Posted: 15 April 2010

    When an unapproved drug that had been in use for years to treat gout received approval by the US Food and Drug Administration (FDA), the treatment suddenly became as much as 25 times more expensive. Colcrys, the brand-name version of colchicine, a gout drug that predated FDA’s existence, costs patients as much as $125 to $150 per month, up from $5 to $10 a month for the previously unapproved version. In addition, other unapproved versions still being sold have become more expensive as well.

    Read more:
  • Oversight of Medical Smart Phone Apps Under Consideration

    Posted: 15 April 2010

    Physician use of medical smart phone applications is becoming increasingly common in the practice of medicine and regulatory agencies must consider how much oversight is appropriate. Medical applications are technically medical devices, but there are not yet any explicit guidelines in place from the US Food and Drug Administration (FDA) or other agencies. FDA is currently considering various degrees of oversight. According to Jeff Shuren, director of FDA's Center for Devices and Radiological Health, regulation could focus on postmarket safety using an electronic registry.

    Read more:
  • Quebec Could Sue Drugmakers Over Ontario Rebate Deal

    Posted: 15 April 2010

    Canada’s provincial government of Quebec may sue drugmakers after learning that they paid significant rebates to the government of Ontario in violation of a price-match deal negotiated four years ago. The agreement between Quebec and pharmaceutical companies requires drugmakers to match the lowest price for prescription drugs anywhere in Canada for Quebec’s publically-funded drug benefit program. However, the Ontario rebates have dropped prescription drug prices there to as much as 40% below the market rate. Officials in Quebec say the province was cheated.

    Read more:
  • FDA Seeks Consumer Reps for Advisory Committees

    Posted: 8 April 2010

    The US Food and Drug Administration (FDA) has put out a call for consumer representatives to serve on its advisory committees. According to an FDA statement, advisory committee members need not be doctors, scientists or a healthcare professionals but must exhibit “a desire to advocate on behalf of the public” or have strong ties to consumer or community-based organizations. The agency will hold a public meeting 30 April for those interested.

    Read more:
  • Drugmakers Decry Price Controls in Germany

    Posted: 8 April 2010

    Drugmakers have sharply criticized the German government’s plan to impose price controls on new drugs, calling the move “devastating” for investment in the country. The new rules will require manufacturers of new medicines to provide evidence of cost/benefit superiority over currently available treatments to provide the basis of price negotiations with insurers. Companies would be permitted to set the drug’s price for the first year after its launch but insurers could impose a mandatory short-term rebate of as much as 16%, an increase over the current rate of 6%.

    Read more:
  • Drugmakers Step Cautiously Into Social Media

    Posted: 8 April 2010

    Pharmaceutical companies are devoting increasing attention to social media outlets in their promotional efforts, despite a lack of guidance from regulators. Social media initiatives now account for about 5% of drugmakers’ promotional spending, according to one professor of pharmaceutical marketing at St. Joseph’s University in Philadelphia. The US Food and Drug Administration (FDA) has expressed concern about the use of social media to disseminate misleading or incomplete promotional information and held a public meeting on the subject last autumn, but has yet to issue any formal guidelines.

    Read more:
  • Proposed Ohio Cloning Ban Could Impact Research

    Posted: 8 April 2010

    An Ohio senator has reintroduced legislation to ban cloning that stem cell researchers say will hamper their work and hurt the state’s biotechnology industry. Critics of the proposal point out the distinction that the bill fails to make: that of reproductive cloning—creating humans––vs. therapeutic cloning for research purposes, which can lead to breakthroughs in medical treatments. If passed as currently written, the bill’s broad language could have a chilling impact on research throughout the state.

    Read more:
  • Judge Nullifies Patents on Two Human Genes

    Posted: 1 April 2010

    A federal judge’s decision Monday, striking down patents on two genes linked to breast and ovarian cancer could throw the patents covering thousands of human genes into doubt and is causing anxiety in the biotechnology sector. The decision by US District Judge Robert Sweet challenging whether anyone can hold patents on human genes was expected to have broad implications for the biotechnology industry and genetics-based medical research. The judge said his findings were consistent with Supreme Court rulings that have established that purifying a product of nature does not mean it can be patented. The ruling came in a long-running fight between scientists who believe genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward.

    Read more:
  • Pharmaceutical Reform Bill in Russian Parliament

    Posted: 1 April 2010

    A bill has just gone through the Russian parliament, the Duma, aiming to rekindle development of the domestic pharmaceutical industry. If passed, following a third reading in September, it will set a maximum price on 500 drugs including treatments for tuberculosis and diabetes—a move designed to make them more affordable. Included in the new measures are plans that would require authorities to publish a price list at every pharmacy. Another important measure aims to protect the market from counterfeit medicines and ensure companies that manufacture drugs in Russia comply with European quality standards by 2014.

    Read more:
  • CDRH Managers Cleared

    Posted: 1 April 2010

    The US Food and Drug Administration announced Tuesday that the HHS inspector general has found that managers at the Center for Devices and Radiological Health did not engage in criminal actions against scientists who opposed the approval of several medical devices. The allegations concerned approvals of some medical devices over the objections of veteran doctors and scientists inside the agency. Some reviewers had alleged that managers had retaliated against them, that approvals had not been documented appropriately, and that decisions were influenced by the industry or politicians. In 2008 and 2009, a group of whistleblowers wrote to Congress and President Barack Obama that the device division was "fundamentally broken." They complained their jobs were affected after they had raised their concerns.

    Read more:
  • WHO Invites Comments on Draft Guideline

    Posted: 1 April 2010

    The World Health Organization (WHO) has issued the proposed guidance, Guideline for the Production and Control of Specified Starting Materials. The document focuses on those materials used as or in the production of active pharmaceutical ingredients (APIs) and aims to offer a global approach to defining quality. The guidance details quality levels for some materials and states that for others a risk assessment, considering such factors as the number and nature of synthesis steps, may be suitable. Comments on the document can be submitted until 1 May and those received by 23 April could be discussed at the consultation on paediatrics and generic guideline development.

    Read more:

March

  • Drugmakers to Benefit From US Healthcare Reform

    Posted: 24 March 2010

    As an early supporter of President Obama’s effort to pass healthcare reform, the pharmaceutical industry stands to be one of the biggest beneficiaries of the legislation passed this week by the US House and Senate. Drugmakers successfully traded short-term concessions for long-term gains. For agreeing to contribute $80 billion worth of cost savings up front, drug companies could recoup as much as $115 billion in new business over the next 10 years. Makers of novel biologics also scored 12 years of market exclusivity for innovator biologic drugs, which the President had originally favored granting seven years of protection, effectively maintaining a high barrier to market entry for biosimilars.

    Read more:
  • Unique Collaboration Could Speed Cancer Drugs to Market

    Posted: 24 March 2010

    A unique, new collaboration among several drugmakers, the US government and nonprofit groups could help get breast cancer drugs to patients more quickly. The five-year, $26 million study called Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, will attempt to use DNA to match the best drug to each patient and to more quickly eliminate those that do not work or are too toxic. In an unusual arrangement, the companies have agreed to share information on the DNA testing as part of the Biomarkers Consortium, which also includes the US Food and Drug Administration (FDA) and the National Institutes of Health. Up to 12 different cancer drugs will be tested. Also unique, FDA will allow the study to drop and add drugs throughout the course of the trial without having to stop to write a whole new protocol.

    Read more:
  • Theranostics Underutilized by Drugmakers, Says Report

    Posted: 24 March 2010

    The field of theranostics, which helps to determine the best drug for a given patient, is going to become increasingly important for drugmakers but is currently underutilized, argues a new report. Theranostics is the science of developing molecular assays to help predict the most suitable drug for a patient and assess its efficacy. As pharmaceutical companies increasingly explore applications for personalized medicine, they will need to strengthen their expertise in this key area. According to the report from Frost & Sullivan, theranostics “plays a crucial role in every step of drug development process, primarily in the form of biomarker discovery, target selection and validation of biomarkers.” Its key applications are in cancer, cardiovascular diseases and neurological disorders.

    Read more:
  • Drugmakers to Send Vaccines to Poor Nations

    Posted: 24 March 2010

    Pfizer and GlaxoSmithKline signed a landmark 10-year deal this week to supply 60 million doses per year of pneumococcal vaccines to developing nations at deep discounts. The deal, brokered by the Geneva-based Global Alliance for Vaccines and Immunization (GAVI), is the first under a new scheme called an Advance Market Commitment, which guarantees a market for vaccines supplied to poor nations but sets a maximum price drugmakers can receive. GSK and Pfizer committed to supply the vaccines at $7 per dose for the first 20%, and $3.50 per dose for the rest, compared with retail values of between $54 and $108. GAVI estimates the vaccines could save up to seven million lives by 2030.

    Read more:
  • Regulatory Workload Up at Drug R&D Companies

    Posted: 18 March 2010

    As drug development activity continues to rise across the world, the workload for regulatory professionals at pharmaceutical and biotechnology companies has dramatically increased, according to a new study. The study from the Tufts Center for the Study of Drug Development found that the regulatory function within drug development firms has grown steadily over the past decade, with most tending to hire from within. Researchers say that with more clinical trial work being outsourced, regulatory professionals are increasingly needed to coordinate and communicate with external providers, overseeing the whole process while improving efficiencies. The study also found that regulatory departments support an average of 100 major projects per year, two-thirds of which are in clinical research phases.

    Read more:
  • FDA Reconsidering Third-Party Reviews for Devices

    Posted: 18 March 2010

    As the US Food and Drug Administration (FDA) reevaluates its approval process for medical devices, the agency is taking a critical look at its third-party review program. Intended to improve efficiency and save time and money, the program allows accredited third parties to conduct the primary review of certain eligible devices as part of FDA’s 510(k) review process. But the program has been criticized within the agency as officials question the quality of the reviews and whether they have actually served their intended purpose. An FDA official said last year that there is a perception that the third-party review is a friendlier process. Private reviewers and the device industry have responded by defending the quality of the outside work and pointing out that FDA still maintains its authority over the final approval decision.

    Read more:
  • "Pharmerging" Markets Grow in Number, Importance

    Posted: 18 March 2010

    Pharmaceutical industry growth is continuing to shift to the so-called "pharmerging" markets. The number of high-growth pharmaceutical markets within emerging market economies has grown to from seven to 17, and their overall sales are predicted to grow by $90 billion during the 2009-2013 period, contributing 48% of annual market growth in 2013 compared to 37% in 2009, according to a market research report. By comparison, growth rates of more mature pharmaceutical markets will continue to decline as they face high rates of patent expiration and increased use of generics, underfunding of the biotech sector, changes in reimbursement schemes and tighter government restrictions related to product safety and pricing, says the report.

    Read more:
  • South Korea Poised to Lead on Biosimilars

    Posted: 18 March 2010

    Last year, South Korea created a regulatory pathway for follow-on versions of biologic drugs, or "biosimilars." Now, local and foreign companies have begun to invest in developing biosimilar products there, causing some to predict the country is set to emerge as a global leader in biosimilars. South Korean electronics giant Samsung has committed to invest $389 million (US) in biosimilars and indicated it would be aggressive in the area. The country has also already hosted a successful clinical trial of a biosimilar version of a rheumatoid arthritis and psoriasis drug from a Taiwanese drug development company, and there is an agreement in place between a US drugmaker and a South Korean counterpart to develop and co-market eight biosimilar medicines. South Korea’s long history in manufacturing biologics also makes it an attractive place for further development of biosimilars.

    Read more:
  • FDA Goes on the Road to Promote Orphan Drug Development

    Posted: 11 March 2010

    In an effort to encourage the development of drugs for rare diseases, the US Food and Drug Administration (FDA) has begun a series of workshops outside the Washington area to provide regulatory advice for potential drug sponsors. The first such workshop was recently held in California and another is planned for August at the University of Minnesota. The agency may even hold one in Europe. While the Orphan Drug Act gives companies incentives to create therapies for those diseases that affect fewer than 200,000 patients in the US, treatments exist for only a small fraction of the approximately 7,000 such conditions. Companies want to have a reasonable expectation of making a profit before they begin the expensive development process. The workshops help give potential sponsors feedback on issues that could delay or derail applications.

    Read more:
  • German Health Minister to Propose Drug Price Controls

    Posted: 11 March 2010

    In a move to save on healthcare costs, German Health Minister Philipp Roesler intends to compel brand-name drugmakers to negotiate lower prices directly with insurers, according to a German magazine report. The proposed plan would impose a price ceiling on drug companies if they fail to negotiate and is intended to save two billion euros annually. Germany, along with the UK, has been one of Europe's last free upfront drug pricing markets, allowing companies a large measure of control over setting new drug prices.

    Read more:
  • Report Cites Lack of Comparative Effectiveness Studies

    Posted: 11 March 2010

    While much has been made of the notion of comparing the effectiveness and cost value of various medical treatments, there currently is little such research being conducted, according to a report this week in the Journal of the American Medical Association. Researchers looked at 328 drug studies published in major medical journals. They found most such research being done at academic institutions or by other noncommercial enterprises. The researchers found most research simply tested whether one drug is better than another and did not compare the drugs to alternative treatments. Less than 20% examined safety and just 2% included an analysis of cost effectiveness.

    Read more:
  • Expiring Patents Will Slow Pharma Market Growth in Belgium

    Posted: 11 March 2010

    The expiring patents of a number of brand-name drugs will slow growth in Belgium’s pharmaceutical market to about 0.46% per year through 2014, according to a new forecast. This is down from 3.4% average annual increases between 2004 and 2009. This is bad news for the branded drug industry in Belgium, a market with high per-capita drug spending. Last year the Belgian drug market was worth 4.59 billion euros and will be worth 4.75 billion euros in 2010, falling to 4.57 billion euros in 2013 as medicines continue to lose patent protection, says the report. Sales are predicted to climb upward again beginning in 2014, with growth forecast for biologic drugs and personalized medicines.

    Read more:
  • FDA to Increase Criminal Prosecutions

    Posted: 4 March 2010

    The US Food and Drug Administration (FDA) plans to increase criminal prosecutions of pharmaceutical and food industry executives, according to FDA Commissioner Margaret Hamburg. The statement came in a letter to Sen. Chuck Grassley (R-IA), saying an internal committee has recommended that FDA "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool." The agency has the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability,” but the provision has not been used much in recent years.

    Read more:
  • Campaign Seeks to Limit Risk From CT Scans

    Posted: 4 March 2010

    A nationwide push is underway in the US to lower radiation exposure from CT scans, amid growing concern about increased cancer risks associated with the high-powered imaging technology. Studies show that a third or more of scans may be unnecessary and in scans that are medically appropriate, radiation doses could be dramatically reduced without hurting the quality of the images. The Society for Pediatric Radiology is sponsoring an “Image Gently” campaign to promote use of the smallest amount of radiation possible during an imaging study. The group also is urging radiologists to take other precautions, including covering areas of the body such as reproductive organs, and to consider alternative tests such as ultrasound.

    Read more:
  • DTC Drug Ad Spending Up 2%

    Posted: 4 March 2010

    Drugmakers’ spending on consumer advertising last year rose 1.9% to $4.5 billion from 2008, according to the latest Nielsen data. Spending on the two largest categories was mostly unchanged, with television up just 0.6% and advertising spending in national magazines down 0.6%. Broadcast television spending fell nearly 6%, while spending on cable networks continues to increase significantly. A Nielsen executive cited longer advertisements due to pressure from the US Food and Drug Administration to present more balanced risk/benefit information as one reason for the increase. Newspaper advertising spending was up 11% to $162 million and radio spending more than doubled to $46 million. Spending on Spanish-language cable networks was up 409% to $4 million and Spanish-language broadcast television spending increased 294% to $29 million. Internet advertising rose 31%to $117 million.

    Read more:
  • Concerns Grow Over Metal Hip Implants

    Posted: 4 March 2010

    The type of hip implants known as “metal on metal” implants have raised concern that they are causing severe tissue and bone damage in some patients, and some orthopedic surgeons have ceased using them altogether. In some cases, the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, were thought to be more durable than previous types of implants and became widely used in recent years. The studies conducted thus far have been limited, but estimate that 1–3%of implant patients could be affected by the problem, meaning thousands in the US alone.

    Read more:

February

  • Generics Review Time Up, User Fees Could Help

    Posted: 25 February 2010

    The US Food and Drug Administration (FDA) is taking much longer to approve new generic drugs today compared to five years ago and FDA Commissioner Margaret Hamburg believes user fees for generic drugs can help. Five years ago, FDA’s average time to approve a new generic was 16.3 months, but by last year, such approvals took an average of 26.7 months. The delays have been caused by a growing backlog of applications and limited staff to review them. Hamburg said last week that the agency’s generic drugs department was underfunded and that collecting user fees from generic drug sponsors could help alleviate the situation.

    Read more:
  • EMA Seeks Closer Ties With Health Tech Assessors

    Posted: 25 February 2010

    As part of the European Medicines Agency's five-year strategy document, the "Road Map to 2015," the agency is seeking closer ties with national-level health technology assessment (HTA) bodies, including the UK’s National Institute for health and Clinical Excellence (NICE). The agency recently launched a series of workshops with European HTA bodies to discus how to involve them earlier in the drug development process. European regulators are concerned about the confusion that could result from the appearance of having two parallel systems with slightly different requirements: one focused on clinical risks and benefits, and the other on relative effectiveness and cost benefits.

    Read more:
  • 510(k) Approval Process for Devices Scrutinized

    Posted: 25 February 2010

    The US Food and Drug Administration (FDA) held a daylong public hearing last week to collect input to strengthen the 510(k) premarket notification process for review of medical devices. Most medical devices are approved in the US through 510(k), but the process has been under increasing scrutiny from both outside and within FDA. The program is often called a "fast-track" program because it relies on previous approvals of similar devices. Critics charge that this approach isn’t rigorous enough. Others fear that changes to the system might create a burdensome process that could stifle the innovation often driven by small start-up companies.

    Read more:
  • NIH, FDA Announce Plan to Speed Innovative Treatments

    Posted: 25 February 2010

    The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new partnership intended to help speed up the process of bringing innovative medical therapies to patients. According to FDA, the initiative involves the interrelated scientific disciplines of translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. The agencies will establish a Joint NIH-FDA Leadership Council to coordinate the efforts, and to help ensure that regulatory considerations are taken into account in biomedical research planning and the latest science is integrated into the regulatory review process. NIH and FDA will also make $6.75 million available over the next three years to help fund regulatory science research.

    Read more:
  • Biopharma Companies in Listening Mode on Social Media

    Posted: 18 February 2010

    While most of the technology business world has embraced social media strategies, biotechnology companies remain in more of a listening mode. Biotechs and other life sciences companies naturally have been slow to take a proactive role because of the highly regulated world in which they do business. Anything that may be perceived as promotional in nature risks inviting scrutiny from regulatory agencies such as the US Food and Drug Administration (FDA). As was seen last March, FDA sent out a rash of warning letters to a group of large drugmakers in a single day because the companies’ Google search ads did not include information about drug risks.

    Read more:
  • Patents Still an Obstacle to Brand Name Drugmakers in India

    Posted: 18 February 2010

    Drugmakers have had their eyes on India as a prospective growth market for some time but the Indian patent system remains a stumbling block. India’s growing healthcare spending, a relatively inexpensive pool of skilled labor and many potential local partners have attracted a lot of investment from many large pharmacuetical companies. However, patents are still much harder to come by there, compared with other markets. Just last week, the Delhi High Court refused to block approval of a copycat version of a brand name cancer drug. This is only the latest example of a top-selling drug being denied patent protection or, in some cases, enforcement. Drugmakers want greater protections, but Indian officials say their system is fair.

    Read more:
  • Counterfeit Drugs a Serious Problem in Middle East

    Posted: 18 February 2010

    Sale and distribution of counterfeit drugs remains a widespread and dangerous problem in the Middle East. A recent seizure of fake drugs in Syria provides some inkling of the scale of this problem. The haul netted millions of dollars worth of phony breast cancer, leukemia and other medicines, along with tens of thousands of anticoagulant pills that purported to treat heart attacks and other diseases, and at least 65 people were detained. Distributors not only sold the fakes to private pharmacies but also to public heathcare systems, particularly in Iraq.

    Read more:
  • FDA Releases Quarterly List of Safety Investigations

    Posted: 18 February 2010

    The US Food and Drug Administration (FDA) released its quarterly list of drug safety probes to inform the public about early investigations of potential side effects that have been reported. The lists released this week covered issues identified between April 2009 and September 2009. More than two dozen drugs were listed. Investigations are probing reports of hearing loss, hypothermia, neurological disorders and other adverse events that may be connected to marketed medicines. Being on the list "does not mean that FDA has identified a causal relationship between the drug and the listed risk," according to the agency.

    Read more:
  • EU’s Centralized OTC Switch Faster but Limited

    Posted: 12 February 2010

    Makers of over-the-counter (OTC) drugs have welcomed Europe’s new centralized procedure for switching prescription drugs to OTC, but the new process also has drawn attention to the problems of existing national processes. National switches comprise the majority of OTC approvals in Europe, and will likely do so until the EU opens restrictions on which drugs can use the new centralized switch process, so most switches must occur via national approval processes, which can take years to complete.

    Read more:
  • Philippines to Reveal Next Round of Drug Price Cuts

    Posted: 12 February 2010

    A second round of voluntary price cuts to popular drugs marketed in the Philippines will be announced next week, according to that nation’s health secretary. The government had asked drugmakers to voluntarily reduce prices on a number of their top-selling and most expensive medicines to avoid government-imposed cuts. Price reduction proposals were due to the government by 22 January and the Pharmaceutical and Healthcare Association of the Philippines confirmed that its member companies had complied with the request, but also has called on the government to find a “more sustainable” approach to ensuring Filipinos’ access to medicines and health care.

    Read more:
  • US Government to Create Horizon Scanning System

    Posted: 12 February 2010

    The Agency for Health Care Research and Quality (AHRQ) will use some of the $1.1 billion in federal stimulus money set aside for comparative effectiveness research to create a "horizon scanning system" for the agency and has requested bids to create a the system. The goal of the project will be to "provide AHRQ with a systematic process to identify and monitor healthcare technologies that are likely to have a high clinical, system and cost impact in the US." Some are concerned about the federal government monitoring what is in the pipeline and possibly discouraging innovation, but AHRQ’s director has said the intention is not to impede, but rather to encourage development effective innovative healthcare treatments.

    Read more:
  • EU Proposes Excipient GMPs

    Posted: 12 February 2010

    The EU’s Committee on the Environment, Public Health and Food Safety has proposed good manufacturing practice (GMP) requirements for excipients as part of an anti-counterfeiting directive. While the European Fine Chemicals Group (EFCG) supports the measure, according to a spokesperson, saying that “patient safety is paramount” and excipient quality is an important aspect of ensuring this, the group has called for a “deeper analysis” of the situation. Some excipients are already appropriately regulated, according to EFCG, and consequently GMP legislation covering all products would be overly broad and burdensome. EFCG proposes singling out only those excipients that are not already covered by existing rules.

    Read more:
  • EU-India Free Trade Talks Criticized

    Posted: 4 February 2010

    Free trade talks between the EU and India resumed last week in Mumbai, but critics in India have complained about a lack of transparency and rumored proposed pharmaceutical patent terms. The text of the draft agreement has not been published and some are decrying the lack of consultation with India’s national parliament and state governments. While no details of the draft’s intellectual property protection terms have been made public, sources say EU representatives are calling for India to accept 20-year patent extensions, a five-year increase over current levels, and extensive data exclusivity provisions.

    Read more:
  • FDA Moves Authority for Radiology Devices to OIVD

    Posted: 4 February 2010

    The US Food and Drug Administration (FDA) has moved its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in an effort to effect more cohesive policies on diagnostic device review. Issues under the purview of the radiological branch, which oversees diagnostic imaging equipment and other radiation-emitting devices, had been the subject of public disagreements within the Office of Device Evaluation (ODE). OIVD Director Alberto Gutierrez commented that the agency had seen discrepancies emerge between how OIVD was regulating diagnostics compared with other divisions within ODE, but an agency spokesperson stressed that the move was meant to address regulatory concerns, not personal tensions.

    Read more:
  • Obama Proposes Generic User Fees

    Posted: 4 February 2010

    The Obama administration is asking Congress to pass legislation allowing the US Food and Drug Administration (FDA) to collect user fees from generic drugmakers, as it does from sponsors of innovator medicines. The money would be used to speed review times and reduce the current backlog of applications, according to the proposed budget documents. Generic drugmakers have been supportive of such user fees as long as they are coupled with improvements in the FDA review process. Some of the money collected could be put toward creating a regulatory approval pathway for biosimilars.

    Read more:
  • EC Issues Medical Device Report

    Posted: 4 February 2010

    A report from the European Commission's Exploratory Process on the Future of Medical Devices was published last week identifying challenges facing the medical devices industry. The Exploratory Process was coordinated by DG Enterprise and brought together European medical device stakeholders.

    Read more:

January

  • DTC Ads More Muted Due to Stricter FDA Enforcement

    Posted: 28 January 2010

    Direct-to-consumer ads for prescription medicines in the US have grown increasingly serious in tone due to stricter enforcement of regulatory guidelines by the US Food and Drug Administration (FDA), according to industry analysts. Consumers may have noticed, for example, decreasing use of sexual innuendo used in ads for erectile dysfunction treatments, and more attention paid to side effect warnings. When Margaret Hamburg was confirmed FDA commissioner last year, she promised more aggressive enforcement of existing ad guidelines. The agency issued almost double the number of warning letters to drugmakers in 2009, compared with the previous year.

    Read more:
  • Drug, Device Recalls Up Sharply in UK

    Posted: 28 January 2010

    The number of product recalls and alerts affecting drugs and medical devices in the UK nearly quadrupled between 2004 and 2008, according to a new study. The report from Blueview Group cites manufacturing errors as the most common reason. Recalls and alerts climbed to 94 from just 22 during the four-year period, with nearly two-thirds attributed to manufacturing defects. The study found 12% of pharmaceutical recalls were caused by labeling and packaging problems and 9% due to compromised sterility.

    Read more:
  • US Orphan Drug Numbers More Than Doubled

    Posted: 28 January 2010

    The number of orphan drug designations in the US more than doubled in the last decade, growing from 208 during 2000-02 to 425 in 2006-08, according to a new study. The Orphan Drug Act was passed in 1983 to promote the development of products for rare diseases or conditions affecting fewer than 200,000 people. Since then, more than 2,000 products have been designated as orphan drugs, and the US Food and Drug Administration (FDA) has granted market approval to 350 drugs and biologics, according to the study conducted by the Tufts Center for the Study of Drug Development. The report also found that, during the 2000s, orphan products comprised 22% of all new molecular entities and 31% of all significant biologics receiving US marketing approval.

    Read more:
  • Electronic Submissions to CDRH on the Rise

    Posted: 28 January 2010

    Electronic submissions to the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) significantly increased from 2008 to 2009. The number of electronically filed device submissions climbed from 4,619 to 21,296 last year, according to FDA statistics cited in a recent post on a regulatory consulting company’s blog. These numbers provide strong evidence of the acceptance of electronic submissions and suggest they could grow further after a final ruling is issued on the agency’s draft guidance on electronic medical device reporting.

    Read more:
  • FDA Names Shuren Permanent CDRH Chief

    Posted: 21 January 2010

    The US Food and Drug Administration (FDA) named Dr. Jeffrey Shuren the permanent director of the agency’s Center for Devices and Radiological Health (CDRH), which has been criticized in recent years from both outside and within FDA itself for a flawed approvals process. Shuren had been serving as the acting head of CDRH since Daniel Schultz resigned as director in August of last year. FDA Commissioner Margaret Hamburg has said she intends to correct the center’s problems and had already begun doing so prior to Shuren’s appointment. According to documents posted on the FDA website, CDRH priorities for 2010 include strengthening product reviews and increasing transparency about decision making.

    Read more:
  • Smart Pill Technology Could Open New Possibilities

    Posted: 21 January 2010

    So-called “smart pills” that can transmit patient health data to external receivers may represent a promising new technology for drugmakers and healthcare providers. Such devices could be used to monitor patients’ reactions to various medications or whether they are following the prescribed dosage regimen. Various studies have estimated that one-third to one-half of prescription drugs are not taken as prescribed, costing an estimated $100 billion a year in the US alone. And with healthcare product makers under increasing pressure to demonstrate the effectiveness of treatments in practice as well as in theory, smart pills could provide needed evidence. However, the technology is not without its critics, as some are concerned about protecting the privacy of patients who may use such a device.

    Read more:
  • New EU Health Chief Calls for Action on Patient Drug Info

    Posted: 21 January 2010

    The EU’s new, incoming health commissioner intends to push to break the deadlock on last year’s proposal to allow prescription drugmakers to provide drug information directly to patients. John Dalli, the commissioner-designate for Health and Consumer Policy told the European Parliament’s Committee on the Environment, Public Health and Food Safety last week that the current draft directive needs to be reassessed to “bring more patient’s perspective in the proposal,” and that there may need to be a “harder demarcation between industry and advertising,” but also declared his general support for patients’ right to accurate information on prescription medicines.

    Read more:
  • UK May Allow Early Drug Access; Funding Uncertain

    Posted: 21 January 2010

    A new proposal in the UK could grant some groups of patients early access to certain new medicines prior to their formal approval. However, the government has no plans in place to provide funding for such drugs. The proposed scheme would allow patients without treatment options to receive drugs in development that could potentially prolong their lives, similar to the US Food and Drug Administration’s Treatment IND regulation, which permits the use of an investigational drug among some patients, provided the drug is for a serious or life-threatening disease and there is at least preliminary evidence of efficacy. Most countries, including the UK, have compassionate use programs permitting patients to obtain investigational drugs on an individual basis, but only a few, including the US, France and Sweden, have programs to allow early access to cohorts of patients.

    Read more:
  • Philippines Asks Drugmakers for More Price Cuts

    Posted: 21 January 2010

    After seeking and getting price cuts for a number of essential medicines last summer, the government of The Philippines is asking drugmakers for a second round of price reductions. While pharmaceutical companies are being asked to voluntarily reduce prices on select medicines up to 50%, the government is prepared to impose reductions as it did last summer for five essential medicines. Prices for an additional 16 medicines were lowered voluntarily by drug companies at the time. Drugmakers had been given an initial compliance deadline of 14 January for this round of cuts, which has now been extended to 22 January.

    Read more:
  • FDA Launches First Phase of Transparency Initiative

    Posted: 14 January 2010

    This week, the US Food and Drug Administration (FDA) launched its new "FDA Basics" area of the agency's website as the first step in its new transparency initiative. FDA Basics is intended to help the public more fully understand how the agency works and includes information about FDA's organizational structure, regulated products, regulatory processes, answers to frequently asked questions and video interviews with agency personnel. During the next phases of the initiative, FDA plans to focus on making information about agency activities more "transparent, useful, and understandable in a manner that's compatible with our goal of protecting confidential information," said Joshua Sharfstein, principal deputy commissioner of food and drugs.

    Read more:
  • EU Investigates Pay-for-Delay Deals; Ban Proposed in US

    Posted: 14 January 2010

    So-called "pay-for-delay" deals to delay competition from generic drugs are being further investigated by the European Commission (EC) while a group of US officials have proposed an explicit ban of the practice. EC antitrust investigators report they have asked unnamed pharmaceutical companies for details of patent settlement deals as part of an ongoing pharmaceutical competition inquiry. At the same time, a group of legislators from the US House of Representatives and the Federal Trade Commission chairman are calling for a provision in the pending healthcare reform legislation that would prevent brand-name drugmakers from directly or indirectly paying generic makers to delay cheaper generic alternatives. The House version of the bill already includes such a ban while the Senate version does not.

    Read more:
  • EU is Slow to Move on Direct-to-Patient Drug Info

    Posted: 14 January 2010

    Last year, the EU proposed a package of legislation, including a provision that would allow drugmakers to distribute nonpromotional information about prescription medicines directly to patients, but has yet to act on it. The goal of such a change would be to provide greater access to information on existing medications without legalizing the type of direct-to-consumer advertising that is allowed in the US. However, the EU appears to be moving slowly as the draft proposal is stalled and is likely to be amended, with the soonest action not likely until May of this year.

    Read more:
  • US Medical Research Funding Down, Say Report

    Posted: 14 January 2010

    Public and private funding for US biological and medical research has slowed and resources from one major federal source shrank when inflation is taken into account, researchers reported this week. The team from the University of Rochester Medical Center said its findings suggest a more cautious future for medical research, and one in which new scientists may shy away from more innovative and risky projects that could deliver potential breakthroughs, in favor of safer endeavors. According to the report, industry sources invested the most in biomedical research, accounting for 58% of all 2007 spending, and the US National Institutes of Health (NIH) was the second-largest source, accounting for 27%, but NIH funding fell by 2% in real terms.

    Read more:
  • FDA Drug Approvals Up in '09; NDAs Need Improvement

    Posted: 7 January 2010

    The US Food and Drug Administration (FDA) approved one more new drug last year than it did the year before—25 in 2009, compared with 24 in 2008. While this is not a big increase, it is the second year in a row of higher approval totals. With Office of New Drugs Director John Jenkins revoking late last year the permission he had previously granted his staff to miss user fee deadlines, innovator drug sponsors are looking forward to favorable new drug review conditions heading into 2010. However, Jenkins recently advised sponsors that they need to submit better applications. Speaking before a group of biopharma executives last month, he told the audience that in his view, too many new drug applications are filed before they are complete to meet sponsors' internal goals.

    Read more:
  • FDA Developing Tougher Standards for Devices

    Posted: 7 January 2010

    In the wake of criticism about the way the US Food and Drug Administration (FDA) handles the approval of medical devices, the agency is developing guidelines that will set tougher scientific approval standards. The new standards will set the bar higher for data from tests on humans that device makers must submit when seeking approval. FDA's acting director of the Center for Devices and Radiological Health told The New York Times that the agency most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, he added.

    Read more:
  • Drugmakers Accused of Promoting "False Pandemic"

    Posted: 7 January 2010

    The Parliamentary Assembly of the Council of Europe plans to convene this month for an emergency debate and inquiry into alleged influence exerted by drugmakers on the World Health Organization's (WHO) global H1N1 flu campaign. Critics charge that drugmakers influenced WHO scientists, encouraging a "false pandemic" in an effort to promote unnecessary flu drug and vaccine sales. In France, President Nicolas Sarkozy, is at the center of a political controversy after health authorities admitted they had a huge oversupply of vaccines for the H1N1 virus and were trying to sell them to other countries. Pharmaceutical manufacturers face the prospect of significantly lower flu vaccine sales than forecast as a growing number of governments seek to renegotiate purchases of unused stocks.

    Read more:
  • UK Clinical Trials Decline Sharply in 2009

    Posted: 7 January 2010

    The latest figures from the UK's Department of Health show a sharp decline in the number of clinical trials conducted in that country. The number of mid- and late-stage and postapproval clinical trials fell from 728 in 2008 to 470 in 2009, the lowest of the past decade. Early-stage trials fell to 210, the lowest in five years. Despite government efforts to encourage UK-based trials, bureaucracy, low recruitment rates and the slow uptake of new drugs are being blamed for pharmaceutical companies' moves to conduct more research in other countries in Europe and North America, as well as increasingly in low-cost, developing nations. The UK's share of global clinical trials fell from 6% in 2002 to 2% in 2007.

    Read more: