FDA on Monday issued final guidelines that essay to demarcation line conflicts of interest among advisory committee members, the San Francisco Chronicle reports.
Under the guidelines, medical experts with more than than a $50,000 financial interest in companies cannot serve on advisory committees that review their products or the products of their competitors. Medical experts with less than a $50,000 financial interest rear end serve, provided that FDA considers their participation necessary and issues a release. The guidelines also allow for FDA in certain cases to nix participation on advisory committees by some medical experts, regardless of whether they have more than a $50,000 financial interest. The $50,000 demarcation line includes stock certificate, grants and other financial interests (Tansey, San Francisco Chronicle, 8/5).
In addition, FDA will change the vote process for advisory committee members from sequential, which often arse influence the votes of other members, to concurrent. FDA volition post a record of the votes of individual advisory committee members online. FDA besides will post briefing materials online 48 hours earlier advisory citizens committee meetings and change the circumstances under which committees meet to address issues.
FDA officials said that the guidelines will drive effect immediately and will be fully implemented within 120 days (Parnass, CQ HealthBeat, 8/4).
Comments
Randall Lutter, a surrogate FDA policy commissioner, said, "It's imperative that we seek advice from main experts and that we do so in a way that is populace, open and transparent" (Bloomberg/Boston Globe, 8/4). He aforesaid, "The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum" (CQ HealthBeat, 8/4). Jill Warner, fourth-year policy consultant at FDA, said that agency efforts to find medical experts without conflicts of interest have proved difficult. She said, "To develop modern products, diligence relies on the same experts."
Sidney Wolfe, director of the Health Research Group at Public Citizen, praised the guidelines. He said, "The whole rudimentary thought is that money talks," adding, "It is at least possible, though it's non certain, that it'll dissemble their ballot" (San Francisco Chronicle, 8/5). In increase, he said, "Over time, the percentage of mass who possess these (conflicts) will diminish," adding, "A lot of it will have to do with how much energy the FDA is willing to expend to find people who don't have a conflict of interest."
Diana Zuckerman, prexy of the National Research Center for Women & Families, aforesaid that FDA should come down the $50,000 limit and that she expects many aesculapian experts with less than a $50,000 fiscal interest to receive waivers to serve on advisory committees. She said, "The FDA has consistently used a very low criterion for granting waivers, and there is no evidence that this will variety" (Freking, AP/Boston Globe, 8/4).
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