October FDA news in review

fda.sp.pngWelcome to the October installment of "FDA News in Review," where each month we look at the agency's latest decision, approvals, warnings and recalls. Over the last few days one of the hottest topics in pharma has been the issue of preemption, which is being argued before the Supreme Court in the case of Wyeth v. Levine. Those in favor of preemption think the FDA approval shields drugmakers from legal challenges in state court. But what do FDA staffers have to say? According to memos obtained by the Wall Street Journal, the FDA's labeling decisions aren't always based on the best possible information. "[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," wrote one top official.

Another important story this month was the FDA's continuing difficulty meeting drug approval deadlines. So far this year the agency missed deadlines for Promacta, Nplate, Telavancin, Entereg, Cimzia, Lexiscan, Kynapid and alogliptin. The FDA says staffing shortages are to blame; critics say the agency is hesistant to approve drugs because of recent safety issues with some high-profile therapies. There were a number of approvals announced this month, however. The agency gave the ok to Genzyme's Myozyme, Lev Pharma's Cinryze and Bayer's Kogenate, among others.

What's New at the FDA

  • Memos show FDAers fought preemption
  • Creating a center of excellence in China
  • FDA weak on foreign plant oversight
  • Regulatory environment helps biotech
  • Adverse event reports hit record high

Safety, Warnings and Recalls

  • Devices get cursory FDA scrutiny
  • Genentech's Raptiva gets 'black box'
  • No more cold meds for kids under four
  • Stent, drug makers team up on clot study
  • Ranbaxy waves white flag at Feds


FDA Decisions

  • As promised, FDA misses deadlines
  • FDA lets dying lawyer have Tysabri
  • Daiichi, Lilly: still no word on prasugrel
  • FDA delays review of Takeda's alogliptin

FDA Approvals

  • Genzyme's Myozyme approved
  • Lev Pharma wins FDA approval for Cinryze
  • Watson wins regulatory OK for Rapaflo
  • Akorn wins FDA OK for eye anesthetic
  • Bayer gets Kogenate approval


October FDA news in review
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