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November 16, 2012News for the food and drug law community

  Drugs & Biologics 
  • Hamburg to Senate: "I wish that responses had been more timely"
    Regulators could have done more and worked together better before the meningitis outbreak linked the New England Compounding Center, but the agency's power to act was "limited, unclear and contested," Commissioner Dr. Margaret Hamburg testified Thursday before a Senate panel. An owner of the NECC who cited his Fifth Amendment rights and did not testify at Wednesday's House hearing on the outbreak did not appear at Thursday's Senate hearing. Politico (Washington, D.C.) (11/16) Email this Story
  • Senators open to changes in regulation of compounders
    Republican and Democratic senators indicated at a hearing Thursday that they would be open to changes in the oversight of compounding pharmacies to prevent outbreaks like the one tied to tainted steroid injections from the New England Compounding Center. Sen. Lamar Alexander, R-Tenn., said the FDA could be given the power to certify states to regulate large-scale compounders, and the FDA would have the ability to decertify states that don't live up to the responsibility. Reuters (11/15) Email this Story
  • FDA panel: Data on effects of Dynavax's hep B vaccine insufficient
    The FDA's Vaccines and Related Biologics Advisory Committee voted 13-1 in support of the efficacy of Dynavax's hepatitis B vaccine Heplisav, but they questioned its safety and asked whether more trial data was needed involving blacks, Asians and Hispanics. The FDA could decide on the application by Feb. 24. MedPage Today (free registration) (11/15) Email this Story
  • Deal with states over Avandia promotion to cost GSK $90M
    GlaxoSmithKline will pay 37 U.S. states and Washington, D.C., $90 million to settle allegations that it illegally promoted diabetes treatment Avandia. The deal resolves claims that GSK misled consumers about the risk of strokes and heart attacks tied to the drug in order to improve sales. "This settlement ... marks an important step in resolving long-standing legal matters," company spokeswoman Bernadette King said. Bloomberg Businessweek (11/15) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  • Health group seeks FDA action on caffeinated snack
    The Center for Science in the Public Interest is urging the FDA to act against Cracker Jack'D, a new Cracker Jack product with caffeine, arguing that it is not healthy for children. "The FDA considers caffeine safe for use in cola-type beverages up to 0.02 percent," CSPI wrote. "The lack of a standard for other products makes its use in those illegal." The Hill/Healthwatch blog (11/14) Email this Story
  Medical Devices 
  • Cook gets FDA OK for device to treat peripheral artery disease
    The FDA has granted Cook Medical approval for its Zilver PTX drug-eluting peripheral stent, the first such device to be approved in the U.S. The self-expanding metal stent, which is coated with the paclitaxel drug, is used to reopen blocked or narrowed femoropopliteal arteries in patients with peripheral artery disease. (11/15) Email this Story
  • Teleflex's vascular access catheter scores 510(k) clearance
    The FDA has cleared Teleflex to market its Nylus catheter, which is delivered peripherally to the central venous system. The device was first cleared in Europe in July and is intended to help minimize the risk of blood clot-related complications during infusions, among other applications. (11/15) Email this Story
  • Medtech leaders hit Capitol Hill to push for end to device tax
    A group of 50 top industry executives descended on Capitol Hill this week to inform lawmakers about the 2.3% medical device tax's "devastating effect" on jobs and get them to repeal it during the lame-duck session, said David Nexon of the Advanced Medical Technology Association. "[T]his excise tax will raise our industry's federal tax liability by an amount equal to a whopping 29% of our current income tax payments," Nexon said, referencing an AdvaMed report released Wednesday about the cost of the device tax. (11/14) Email this Story
  FDLI Items 
  • Is Calif.'s Proposition 65 as Applied to Dietary Supplements in Conflict With Federal Law?
    This issue of Policy Forum (Volume 2, Number 21), Is California's Proposition 65 as Applied to Dietary Supplements in Conflict with Federal Law?, explores whether private litigation actions under California's "Safe Water and Toxic Enforcement Act of 1986" (Proposition 65) should be preempted when state requirements conflict with FDA. Authors Nicolas Licato, general counsel for Nexgen Pharma, and Michael Lanosa, law student at the University of Southern California, describe a savings clause that allows California-specific requirements in Proposition 65 to prevail, even when they conflict with federal requirements. Licato and Lanosa conclude that FDA should adopt national standards for contamination of dietary supplements, and that any settlement agreements which hold manufacturers to a state-specific standard should be preempted by federal law. Members: Download now. | Nonmembers: Purchase for $24.95. Email this Story
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Wisdom is not acquired save as the result of investigation."
--Sara Teasdale,
American poet

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