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  • Advisory Committee Lends Limited Support to Pfizer's Tafamadis

    The US Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on 24 May to partially support Pfizer's drug, tafamadis, which is looking for FDA approval to treat a rare neurodegenerative disease. The panel voted 13 to 4 against the drug in an initial vote, saying study data did not show the drug to be effective in directly slowing the progression of familial amyloid polyneuropathy (FAP). The committee later voted again, ...
  • FDA Panel Recommends Restarting Testing of Controversial Pain Drugs

    An US Food and Drug Administration (FDA) Advisory Committee Panel recommended clinical trials testing anti-nerve growth factor inhibitors (anti-NGF inhibitors) be allowed to continue, with certain precautions, reports The Associated Press. The Arthritis Advisory Committee (AAC) voted 21-0 on 12 March to recommend that research continue in light of the unmet needs of patients. Panelists noted many patients do not respond to existing pain medications such as aspirin a...
  • US Regulators Reassessing Anti-NGF Pain Pills Linked to Joint Damage

    The US Food and Drug Administration (FDA) is reassessing whether or not manufacturers of anti-nerve growth factor (anti-NGF) pain pills should be allowed to proceed with clinical trials after a two year hold on existing clinical trials, reports Reuters . The trials were stopped in 2010 after hundreds of clinical trials participants required joint replacement surgery after taking the drugs, though testing was allowed to continue for terminally ill cancer patients. Pfize...
  • New Guidance on Conflict of Interest Disclosures for Advisory Committees

    The US Food and Drug Administration (FDA) released new draft guidance on 8 March about the availability of conflict of interest information and waiver information for members of advisory committees. The guidance also establishes a procedure for disclosing financial interest and granting conflict-of-interest (COI) waivers to special Government employees (SGEs) and regular employees. The guidance also provides a standardized mechanism for public disclosure of such document...
  • Defying Ban, Lobbyists De-Register to Serve on Advisory Committees

    A 2009 order by the Obama administration meant to ban registered lobbyists from serving on federal advisory committees-including those used by the US Food and Drug Administration (FDA) to provide it with expert opinions-has instead caused to those same lobbyists to cancel their lobbying registrations in order to continue to serve on the advisory committees, reports The Hill . At least 22 current federal advisory committee members serving on Industry Trade Advisory Commi...
  • FDA Responds to Conflict of Interest Uproar

    The US Food and Drug Administration (FDA) responded to critics of an FDA advisory board decision on Tuesday, saying that critics of the decision exhibited a "lack of understanding about our selection and evaluation process, as well as federally mandated limitations on the type on information [FDA] can share" with the public. Utilizing the new FDA Voice blog, Jill Hartzler, acting associate commissioner for special medical programs, sought to clarify the agency's conf...
  • POGO Lambastes FDA Over Conflict of Interest Report

    The government watchdog group Project on Government Oversight (POGO) has aimed its sights on the US Food and Drug Administration (FDA) over reports that it allowed panelists with potential conflicts of interest to serve as voting members of an advisory committee, even as it took away the voting rights of a vocal critic of the product the advisory committee was voting on.p For further background, please see prior Regulatory Focus coverage here . The group, which calls ...
  • WSJ: Panel Assessing Bayer Birth Control Pills Had Ties to Company

    An advisory committee convened by the US Food and Drug Administration (FDA) to assess the safety of four Bayer AG birth control products had at least three members with ties to the company, according to The Wall Street Journal . The panelists, whose ties with Bayer included serving as consultants, speakers or researchers, did not have their ties to the company disclosed to the public by FDA. An FDA official, Jill Hartzler, told The Wall Street Journal that FDA ...