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Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin

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Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin Antitrust Connection Spring 2009 To: Our Clients and Friends January 19, 2010 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin Top News Push for Final Health Bill Continues Democrats have announced that they hope to reach a final resolution on health care this week, even as Tuesday’s special election to fill the Massachusetts Senate seat formerly held by Edward Kennedy threatens the Democrats’ filibuster-proof majority in the Senate. Democrats are considering alternative options should they lose their 60th vote in the Senate, including asking House Democrats to approve the Senate version of the bill and sending it directly to President Obama for his signature. Some lawmakers are also continuing to push for the exemption of smaller device companies from the proposed $2 billion annual device tax. In addition, on Thursday, a group of House Democrats urged their leaders Jan. 14 to keep certain provisions of the House bill that assist Medicare patients with cost-sharing, reduce out-of-pocket costs, and allow CMS to create a new Part D program. Reports are predicting that the health care reform bill will establish an approval pathway for biosimilars, but people familiar with the legislation say it could be several years before that pathway is truly available for use. In addition, reports are circulating of a deal being floated under which generics would offer up money to help close the Part D doughnut hole and in exchange would get the health reform bill's biogenerics exclusivity for innovator companies lowered to 10 years, with an additional 6 months exclusivity available for pediatrics and new indications. BIO, PhRMA and the Massachusetts Biotechnology Council (MBC) continue to press Congress to maintain the 12-year exclusivity period for biologics. FDA Launches First Phase of Transparency Initiative The FDA has unveiled the first phase of its Transparency Initiative, which is designed to explain agency operations, how it makes decisions, and the drug approval process. The second part of the initiative, slated to occur in February, will involve the FDA providing guidance on how far FDA might go in releasing information currently withheld from the public, including complete response letters, withdrawn applications and other similar material. 1 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin January 19, 2010 FDA Considers PMA Changes The FDA, industry, and others are debating which reforms are necessary to PMA study standards following recent critical reviews. Acting FDA device chief Jeffrey Shuren has stated that the agency will employ tougher standards for pre-market clinical trials and that it plans to release draft guidance on clinical trial design and on gender-related trial design issues. The FDA has announced that it also will revise internal standard operating procedures for device review staff. FDA to Draft Guide on Threshold for RF Exposure Researchers, engineers, biologists and physicians gathered in Gaithersburg, Maryland, last week to help the FDA better understand the thermal hazards of radiofrequency exposure in humans. The FDA has stated that the IEEE International Committee on Electromagnetic Safety intends to use the meeting's outcomes as a guide for the next revision of an IEEE standard on safe levels for human exposure to radio frequency electromagnetic fields. Industry Comments on REMS Draft Guidance The Pharmaceutical Research and Manufacturers of America have provided comments to the FDA’s draft guidance on requirements for Risk Evaluation and Mitigation Strategies, saying that the agency should focus on sponsors' activities and not the behavior of third parties. Kaiser Permanente has called for the agency to open up the process for developing REMS to include elements to assure safe use. The Generic Pharmaceutical Association has called a REMS exemption to allow generic firms that want to develop ANDAs for products in closed distribution systems to obtain samples from the brand sponsors. Postmarket Industry Studies to be Future Challenge for Sentinel Center for Drug Evaluation and Research Director Janet Woodcock has stated that the FDA has not yet decided whether or how drug firms could tap into its upcoming Sentinel electronic drug safety surveillance system to conduct postmarket studies required by the agency, but that the agency would address that problem when they come to it. The Sentinel database will be created under a four-year, $72 million contract between the FDA and Harvard Pilgrim Health Care Inc. Questions Abound Regarding Flu Vaccine As fears about the H1N1 virus continues to lessen, a top World Health Organization official dismissed statements that the agency exaggerated the threat posed by the virus due to influence from the pharmaceutical industry. The EFPIA’s European Vaccine Manufacturers (EVM) group has reiterated that its members did not hype up the threat of the H1N1 pandemic to boost vaccine sales. Sen. Charles E. Grassley (R-IA) sent a letter to HHS Secretary Kathleen Sebelius, FDA Commissioner Margaret A. Hamburg, and CDC Director Thomas R. Frieden on Tuesday questioning the government’s future plans for the vaccine, including whether the government has plans to check the potency of the vaccine over the longer-term as demand lessens. New York AG Settles Regarding Drug Disposal New York Attorney General Andrew Cuomo has announced that a settlement has been reached with five healthcare facilities that flushed pharmaceutical waste into the New York City watersheds. US Accuses Johnson & Johnson of Kickback Scheme The Office of the United States Attorney in Boston has filed a complaint against Johnson & Johnson accusing the company of paying kickbacks to Omnicare to increase the number of elderly patients taking the antipsychotic Risperdal and several other medications. 2 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin January 19, 2010 AAJ Hopes to See Action on FDA Preemption Bill The American Association for Justice has stated that it is continuing to monitor a bill that would allow state courts to hear lawsuits involving FDA-approved medical devices and tort reform pilot projects in health care legislation. Supreme Court’s Refusal to Review Case May Limit Patent Protection Industry experts are concerned that the U.S. Supreme Court’s refusal to hear Boston Scientific’s appeal in a long-running cardiac device patent infringement case with St. Jude Medical will allow device companies to export products made in the U.S. that are capable of performing a patented method outside the U.S. without infringing the U.S. patent. Appeals Court Decision May Indicate Trend Against Preemption for Generic Drug Labeling The U.S. Court of Appeals for the Fifth Circuit ruled that product liability lawsuits related to labeling are not preempted by federal regulations, the second federal appeals court to make such a ruling. Some are concerned that the rulings may indicate a trend against favoring federal preemption for generic-drug makers. Philippines Asks for Further Price Reductions for Medicines The Philippine Department of Health has asked that drug companies reduce by half the prices of the "top-selling and most expensive" medicines with few generic rivals. Sanofi-Aventis has already announced that it will cut the prices of some of its drugs in Southeast Asia to tap rising rates of diseases including diabetes and cancer in the region. Device Companies Send Supplies to Haiti Device companies have mobilized to send emergency medical supplies to Haiti in the wake of the catastrophic earthquake that hit the country Jan. 12. EU Probes Pharmaceutical Companies on Generic Delays The European Commission has issued questionnaires to pharmaceutical companies, including AstraZeneca Plc, GlaxoSmithKline Plc, Sanofi-Aventis SA, regarding details of agreements that may have slowed the sale of generic medicines. The questionnaires are part of the probe by the Commission into strategies employed by drugmakers to prevent generics from entering the market. EU Council Outlines Streamlined Patent System The European Council has approved an outline for a streamlined EU patent system that would include a specialized court. The European Commission estimates that the new system would save companies operating in Europe as much as $415 million annually. UK Early Access Scheme Likely But Without Funding The proposed UK Early Access Scheme may allow patients early access to certain new medicines prior to formal approval; however, the UK government has announced that it will not provide funding for drugs used under the program. Publications The FDA has published a letter from FDA Commissioner Margaret A. Hamburg to America’s health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on safety monitoring of the 2009 H1N1 vaccines. 3 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin January 19, 2010 The CMS Office of the Actuary released a memo last week finding that savings from Medicare cuts will not finance wider coverage and extend the life of the Medicare trust fund. It also states that reducing payments to Part A providers based on productivity gains will not likely be sustained on a permanent annual basis. The GAO has issued a report finding that the prices of a growing number of prescription medications have increased in recent years due to several factors, including consolidation in the drug industry. Lawmakers and other stakeholders are
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