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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 October 30, 2009 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin Top News House Reform Bill Lowers Device Tax, But No Exception for Small Companies The updated House health care reform bill reduces the device industry excise tax to $20 billion (compared to $40 billion in the Senate bill), but includes no exceptions for small companies. Senators Introduce Bill to Eliminate Write-Off for Drug Marketing Costs Senators Al Franken (D-Minn.), Sherrod Brown (D-Ohio), and Sheldon Whitehouse (D- R.I.), have introduced S.1763, a bill that would eliminate the tax write-off for prescription drug marketing costs, as a means to "restore lost revenue" to the federal government. The bill covers direct-to-consumer advertising in any media and "any activity designed to promote the use of a prescription pharmaceutical directed to providers or others who may make decisions about the use of prescription pharmaceuticals (including the provision of product samples, free trials and starter kits)." U.S.-Japan Pilot Project In Pre-Market Collaboration to Begin Soon The FDA and its Japanese counterpart will soon name the two devices that they will use as part of a pilot project in which the countries’ agencies will collaborate on clinical trial protocol development and pre-market review of medical devices. The pilot is part of the of the Harmonization by Doing (HBD) initiative. Pfizer, GSK and Bayer accept Ecuador’s plan to break patents Pfizer, GlaxoSmithKline (GSK) and Bayer have expressed their support for the government of Ecuador’s decision to sidestep patents on more than 2,000 drugs, enabling the country to produce them locally or import them as “generics.” The move is similar to that seen in countries including Brazil and Thailand, who have taken similar action in an effort to reduce drug prices. 1 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin October 30, 2009 A Nation Battling Flu, and Short on Supplies Articles in the New York Times and the Washington Post discuss the causes and effects of the government’s overestimation of the amount of flu vaccine that would be available to the public this month. The Washington Post is also reporting on the shortage of Tamiflu, a recommended treatment for swine flu. In addition, the FDA has announced that it will combat the marketing of unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus, and has launched a website that lists such fraudulent products. WHO to Weigh in On Swine Flu Vaccine Dosage The WHO is set to give its recommendation on whether one or two doses of the swine flu vaccine are needed to combat the disease. DEA crackdown hurts nursing home residents who need pain drugs Senators Herb Kohl (D-Wis.) and Sheldon Whitehouse (D-R.I.), along with a coalition of pharmacists and geriatric experts, have stated that tougher enforcement of the Controlled Substances Act is denying hospice and elderly patients needed pain medication, according to an article in the Washington Post. Stem Cell Research in the States Supporters of embryonic stem cell research are worried that legislation debated in a Michigan state Senate committee could threaten the progress of research in the state, according to an article in the Chicago Tribune. In California, the California Institute for Regenerative Medicine has awarded $230 million in grants to 14 stem cell research projects. Wisconsin Proposal Would Allow Sales of Drugs Below Cost A proposal has passed the Wisconsin Assembly that would exempt prescription drugs from the state’s “minimum-markup” law and allow pharmacies to sell them below cost. Confidential Data in NCAR Restricted to Full Participants, GHTF Says The Global Harmonization Task Force (GHTF) has indicated that it is taking steps to safeguard confidential information in device adverse event reports and postmarket surveillance and has stated that only full participants in its National Competent Authority Report (NCAR) exchange program will be given access to confidential or highly sensitive information contained in the reports. Study Finds Clinicians Favor Bending Clinical Trial Rules An article in the New York Times discusses the findings of a recent study in which investigators found that 90 percent of clinicians in clinical trials believed that ignoring certain entry criteria was acceptable if a patient could, in their estimation, benefit from the trial. In addition, more than half of clinicians surveyed indicated that they thought that researchers should deviate from study rules if doing so might improve a patient’s care. EFPIA Launches Pilot to Combat Counterfeiting The European Federation of Pharmaceutical and Industries Association (EFPIA) is launching a pilot that will apply 2D barcode labelling to 110,000 drug products in 25 pharmacies in Sweden, in an effort to reduce counterfeiting. 2 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin October 30, 2009 Alpha acquires CRO to target Mass bio Environmental laboratory Alpha Analytical has acquired CRO Boston Analytical and is now targeting the Massachusetts, US biotech sector, according to its president Mark Woelfel. Novotech Opens Management Hub in Malaysia Contract research organisation Novotech has opened a new “management hub” in Kuala Lumpur, Malaysia, in what the CRO says will serve as a base for expansion in the booming Asia-Pacific contract research sector. Japan’s Astellas to Pay Up to $765M for Prostate Cancer Drug Rights Astellas Pharma Inc., Japan’s second-largest drugmaker, has agreed to pay $110 million up front and as much as $655 million in future payments to Medivation Inc. for global rights to develop and sell an experimental medicine for prostate cancer. Novartis Prepares For Diovan Patent Expiries Novartis has stated that it is shifting marketing efforts away from its drug Diovan and focusing on drugs such as Tekturna or Exforge in an effort to forestall generic competition that will begin to surface in two years. Judge Dismisses Medtronic Product Liability Claims A Minnesota district judge has dismissed 600 lawsuits filed by patients who claimed they were harmed by a faulty heart defibrillator lead made by Medtronic Inc. Allergan Wins Continued Product Protection for Alphagan Allergan, Inc. has won continued product protection after a judge ruled that generic drugmakers Apotex Inc and Exela PharmSci infringed patents for its Alphagan glaucoma treatment. Sanofi-Aventis Alleges Patent Infringement Sanofi-Aventis has alleged that competitors Hospira Inc. and Apotex Inc. have infringed its patents for cancer drug Taxotere. Appeals Court Rules Bayer Patent Invalid The U.S. Court of Appeals for the Federal Circuit in Washington has ruled that Bayer AG’s patent on birth-control pill Yasmin is invalid. Jury Finds Pfizer Liable for $3.7 M damages for concealing breast cancer risks A Philadelphia jury has concluded that Pfizer is liable for $3.7 million in damages for concealing the risks of developing breast cancer from its hormone-replacement therapy drug Prempro. Johnson & Johnson Whistle-Blowing Trial Begins The trial has begun in the case of a former Johnson & Johnson employee who claims she was wrongfully terminated after blowing the whistle on the company’s off-label promotion of its drug Risperdal. Thus far, a sales representative from the company has testified that he encouraged doctors to prescribe the drug for unapproved uses. 3 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin October 30, 2009 ISO to Develop Tighter Standards for Glucose Monitors by 2012 The International Organization for Standardization’s (ISO) clinical laboratory testing and in vitro diagnostic test systems technical committee has announced that it has launched an initiative to tighten accuracy standards for glucose monitoring devices, which it expects to complete in three years. FDA Completes UDI Pilot, But Anxieties Over Data Requirements Remain Participants in a six-week pilot program aimed at assessing the feasibility of collecting and storing unique device identification data have shared concerns about the volume and type of information that would be required under the program. Medco to Undertake Cost Effectiveness Study Medco has announced that it will undertake a "Genotype-Guided Comparison of Clopidogrel and Prasugrel Outcomes Study" to generate cost effectiveness data comparing Bristol-Myers Squibb's Plavix with the recently launched Effient. The study is part of the firm’s "Genetics for Generics" project. FDA Gives Vyvanse Five Years Exclusivity Shire PLC has announced that the FDA has reaffirmed its prior decision and will give its drug Vyvanse five years of market exclusivity. FDA Panel Backs First Non-Drug Asthma Treatment An FDA panel of respiratory device experts has voted in favor of approving Asthmatx's Alair System for use under certain conditions, including long-term safety monitoring of patients, according to an article in the New York Times. FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients, Settings The FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors
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