FDA on Wednesday announced proposed rules under which medical experts with more than a $50,000 financial interest in pharmaceutical companies could not serve on agency advisory committees that review their products or the products of their competitors, the Washington Post reports.
Under the rules, medical experts with less than a $50,000 financial interest could participate in discussions by advisory committees but could not vote on whether to recommend products. The $50,000 limit includes stock and consulting arrangements (Vedantam, Washington Post, 3/22). In addition, FDA would individually review cases in which academic researchers have potential conflicts of interest that result from funds or research grants paid to their institutions by pharmaceutical companies (Henderson, Boston Globe, 3/22). FDA in rare cases could make an exception to the rules in the event that the agency commissioner considers the participation of a medical expert necessary to a discussion by an advisory committee, according to Randall Lutter, acting agency deputy commissioner for policy (Harris, New York Times, 3/22). Lutter said the rules would affect a significant number of medical experts who currently serve on advisory committees but did not provide an exact number (CQ HealthBeat, 3/21). Under current rules, medical experts with more than $100,000 or 15% or more of their net worth invested in pharmaceutical companies cannot serve on advisory committees. Medical experts must disclose smaller investments in pharmaceutical companies, but such investments do not prevent their participation on advisory committees (Alonso-Zaldivar, Los Angeles Times, 3/22). FDA officials said that the agency will accept public comments on the proposed rules for 60 days but did not announce when they would finalize the rules (Japsen, Chicago Tribune, 3/22).
FDA Comments
FDA officials "maintained that the agency's procedures have not been biased in favor of industry, but the new guidelines implicitly acknowledge what critics have long said -- that it is possible to find enough qualified experts who do not have ties to drug and device manufacturers," according to the Post. Lutter said, "We are very interested in ensuring we have the best possible access to scientific experts" (Washington Post, 3/22). However, Lutter said that FDA has "done a very good job ensuring that the process already deserves the respect of the American public," adding that the agency is "not aware of any instances in which decision-making processes have been unfairly or inappropriately adversely affected by conflicts that members may have" (Boston Globe, 3/22). Lutter added that FDA is "committed to making the process even stronger and better understood" and that the proposed rules will increase "consistency, predictability and transparency" (Los Angeles Times, 3/22).