• FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start

    A fund established under the Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007 is beginning to ramp up activity after several years of cash-strapped stagnation, but not everyone is happy about the move, reports National Public Radio (NPR) . The Reagan-Udall Foundation was created under FDAAA to create an outlet for FDA, industry, academia and patient groups to come together to fund mutually beneficial activities. "The idea was that this foundation c...
  • FDA Seeks Feedback on Postmarketing Adverse Event Drug Reporting

    The US Food and Drug Administration (FDA) is looking for feedback regarding its postmarketing adverse drug experience reporting system, including ways to make the system more efficient and less burdensome for manufacturers. In a 20 March Federal Register posting, FDA said, "Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the ...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponso...
  • FDA Releases Report on Postmarketing Study Requirements

    The US Food and Drug Administration (FDA) released a report 6 March on the postmarketing studies required of sponsors for products approved under the terms of the FDA Amendments Act (FDAAA) of 2007. The act allows FDA to mandate certain postmarketing requirements (PMRs) and postmarketing commitments (PMCs) of sponsors to further assess known risk, signals of serious risk or identify unknown risks. The report notes that the majority of PMRs (87%) and PMCs (75-80%) are o...
  • Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study

    Merck Sharp and Dohme Corp.'s global director of regulatory affairs received a warning letter on 17 February from the US Food and Drug Administration warning Merck that it had failed to complete an agreed-upon postmarketing study for its diabetes medications Januvia and Janumet. The products are now effectively misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act), and the company faces $250,000 in fines, with further fines accruing for continuing vi...
  • Former FDA Commissioner: Approve Drugs Based on Safety, Prove Efficacy Later

    Former US Food and Drug Administration (FDA) Commissioner Andrew Von Eschenbach has an op-ed in the 14 February edition of the Wall Street Journal in which he calls for some drugs to be approved based on only premarket indications of safety, with testing on efficacy and effectiveness to be left for postmarket studies. "[T]here is a growing recognition-at the agency, in the industry and among patients' groups-that it is at serious risk of falling behind its core res...