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October 29, 2009 News for the biotech, medical device, drug and food regulatory profession   Drugs & Biologics  Sales rep says he promoted Risperdal for off-label use A sales representative for Janssen Pharmaceutica testified that he pushed doctors to consider prescribing antipsychotic drug Risperdal for unapproved use in "augmentation therapy." Matthew D. Thompson said in court that the company did not "think about augmentation in the realm of on-label or off-label at that time." Bloomberg (10/28) Repros, NIH amend license for suspended drug Proellex Repros Therapeutics has agreed with the NIH to amend its license for Proellex to give the company more time to resolve issues that prompted the FDA to put the uterine fibroid drug on clinical hold. Repros is trying to determine whether to select a second-generation molecule that would be used to develop anti-progestational agents covered by the license. Reuters (10/28) CMS to reverse reimbursement policy that de-emphasized Avastin The CMS said it will reverse a policy that restricts the prescription of Genentech's Avastin to promote more expensive eye drug Lucentis, possibly before Jan. 1. Genentech supported the move, which would increase reimbursements to doctors who use Avastin in patients with macular degeneration and save the federal government millions of dollars per year. The Wall Street Journal (tiered subscription model) (10/28)   Health Care in Transition  House health care bill to include public option, negotiated rates A health care bill set to be made public by House Speaker Nancy Pelosi, D-Calf., calls for a government-run health insurance plan but with a different approach to setting reimbursement rates, Democratic leaders said. Under the bill's version of the "public option" plan, the government would negotiate rates with health care providers. A public option plan put forward by Senate Majority Leader Harry Reid, D-Nev., also contains a negotiated-rate provision. The Washington Post (10/29), Los Angeles Times (10/29), NYTimes.com (10/28), Google/The Associated Press (10/28), The Wall Street Journal (tiered subscription model) (10/29), CNN (10/28), Reuters (10/29) Lawmakers introduce measures to address health care fraud Six lawmakers on Wednesday introduced a bill that could allow for increased jail time for those involved in health care fraud and allot $20 million more annually until 2016 for government enforcers. The lawmakers said the federal government needs to heighten efforts to combat Medicare and Medicaid fraud to gain more savings for health care reform. The Wall Street Journal (tiered subscription model) (10/28) Health reform should include changing food-production policies The health care system will keep falling apart unless the government improves food regulation and safety, Bob Cesca writes in The Huffington Post. A good starting point would be to refine policies on how livestock are raised by limiting the medications injected into them, improving their feed and keeping them in adequate spaces to prevent toxicity, Cesca writes. The Huffington Post (10/28)   Other News Mass. governor: Health care reform must be tied to cost control Bloomberg (10/28)   Biotechnology  California's stem cell agency awards $230M in research grants The California Institute for Regenerative Medicine has awarded $230 million in grants to 14 stem cell research projects. One of the recipients of the grants is San Diego-based Novocell, which intends to use its $20 million in funding to develop a diabetes treatment using human embryonic stem cells. NYTimes.com (10/28), San Diego Union-Tribune (10/28)   Food & Dietary Ingredients  FDA grants "safe" status to biotech soybean oil Monsanto and Solae have received "generally regarded as safe" status from the FDA for their SDA Omega-3 oil derived from biotech soybeans. The FDA will allow the soybean oil to be used in food products. St. Louis Post-Dispatch (10/28)   Featured Content    Small Business Stimulus Program Gets a Boost Michelle V. Rafter Why 'Charlotte's Web' Suddenly Matters to Marketing Ann Handley Government Plays VC in CleanTech Jen van der Meer Small Business Survival: Become a Collections Expert Polly Schneider Traylor Cardmember Profile: Progressive Promotions, Inc. OPEN Forum Connectodex   Medical Devices  Stryker Biotech faces charges over off-label marketing of devices Boston-based federal prosecutors filed an indictment against Stryker Biotech and some of its employees for allegedly marketing OP-1 Implant and OP-1 Putty -- devices used for spinal and long-bone surgeries -- for uses not approved by the FDA. Stryker Corp., the unit's parent company, said it "is disappointed with this action and still hopes to be able to reach a fair and just resolution to the matter." The Boston Globe (free registration) (10/29), Boston Herald (10/28) FDA panel supports approval of Asthmatx device for severe asthma An FDA panel voted 6-1 to recommend the approval of Asthmatx's Alair Bronchial Thermoplasty System as a first non-drug therapy for patients with severe asthma. The panel cited certain conditions for approval, such as the creation of a patient registry aimed at assessing the long-term safety and efficacy of the device. The Wall Street Journal (tiered subscription model)/Dow Jones Newswires (10/28)   FDLI Items  Perplexed by off-label compliance? Answer ... "Off-Label Communications: A Guide to Sales & Marketing Compliance, 2nd Edition" The second edition features brand-new practical guidance from industry insiders on these watershed events: FDA Final Guidance on Good Reprint Practices; Cephalon ($413 million), Eli Lilly ($1.4 billion); Fraud Enforcement and Recovery Act; Supreme Court's ruling in Wyeth v. Levine. Learn more. Order your copy. 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