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November 19, 2012News for the food and drug law community

  Drugs & Biologics 
  • Stearns vows to get FDA records in meningitis outbreak
    Rep. Cliff Stearns, R-Fla., head of the House Energy and Commerce subcommittee on oversight, could seek to subpoena FDA documents related to a recent meningitis outbreak unless the FDA hands them over. Republicans pressed FDA Commissioner Dr. Margaret Hamburg about their document requests at a hearing last week. "If she will answer our request for e-mails and documentation, we would have more confidence," Stearns said. The Hill/Healthwatch blog (11/16) Email this Story
  • EU backs approval of Sanofi's diabetes and colorectal cancer drugs
    A European Medicines Agency committee has recommended approval of Sanofi and Zealand Pharma's Lyxumia as a therapy for type 2 diabetes. Sanofi and Regeneron Pharmaceuticals' anti-angiogenic agent Zaltrap also won approval recommendation from the Committee for Medicinal Products for Human Use as a treatment for advanced colorectal cancer with chemotherapy. CNBC/Reuters (11/16), Bloomberg (11/17) Email this Story
  • Shortages remain despite regulatory, industry actions
    Drug shortages have prompted a presidential order, congressional hearings and promises of improved communication from makers of generic drugs. About 150 new shortages have been prevented, according to the FDA. "We're seeing real change in the number of shortages that we're able to recognize early," FDA Commissioner Dr. Margaret Hamburg said. However, the shortages are not going away because a drug tends to remain scarce once it becomes scarce, said Erin Fox, who tracks drug supplies at the University of Utah. The New York Times (tiered subscription model) (11/16) Email this Story
  Food & Dietary Supplements 
  • FDA records show 1,500 airline food violations over 4 years
    The FDA found a much higher rate of significant problems at the airline industry than in other industries the agency inspects. Aside from evidence of mice that Delta Air Lines said was isolated, the FDA found problems such as mold, a lack of hand-washing and dirty cooking areas time after time. ABC News (11/17) Email this Story
  • FDA posts 21 injury reports tied to Red Bull since 2004
    The FDA published 21 reports filed since 2004 that cited the top-selling energy drink Red Bull, including those that involved hospitalizations for vomiting and heart problems. The filings seem to underscore the patchwork regulatory pattern governing highly caffeinated drinks, and highlights the lack of data faced by the FDA in determining if it is necessary to implement additional regulations, according to this article. The New York Times (tiered subscription model) (11/16) Email this Story
  Medical Devices 
  • FDA clears Quantel Medical's eye treatment device
    Quantel Medical has been cleared by the FDA to market the SupraScan 577 laser system. The device provides U.S. eye specialists with access to the most advanced solid-state yellow scanning laser to treat retinal conditions, the company said in a release. (11/16) Email this Story
  • IPhone-based body thermometer scores 510(k) clearance
    The FDA has given Raiing 510(k) clearance to market a reusable thermometer sensor worn under the armpit that can contain as much as 72 hours worth of body temperature readings. The Raiing Wireless Thermometer uses Bluetooth to send real-time temperature data continuously to the Vitals Monitor software, a companion application accessible via the iPhone. (11/16) Email this Story
  • Ind. lawmakers look to defer device tax implementation
    Efforts are ongoing to put off implementation of the 2.3% medical device tax by one to two years, said Indiana Reps. Marlin Stutzman, a Republican, and Joe Donnelly, a Democrat, who expressed opposition to the tax. Plans to defer the tax could be included in a fiscal proposal Congress is devising to stop $600 billion in automatic tax hikes and spending reductions from taking effect, Stutzman said. The Journal Gazette (Fort Wayne, Ind.) (11/16) Email this Story
  • E-cigarettes distributed for free despite ban sought by WHO
    Electronic Cigarette Hub started distribution of free electronic cigarette starter kits after a World Health Organization summit that urged public health officials to ban the technology. Some see e-cigarettes as cessation aids because the smoking experience is similar to regular cigarettes. VentureBeat (11/18) Email this Story
  Hot Topics 

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  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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