New FDA Rules Aim To Prevent Conflict of Interest in Approvals
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 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 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).
Rep. Maurice Hinchey (D-N.Y.), who has proposed legislation to prevent conflicts of interest among medical experts who serve on advisory panels, said that the proposed rules represent a "complete change in perspective and a completely renewed awareness of responsibility within" FDA (Bridges, AP/Philadelphia Inquirer, 3/22). Hinchey added, "By ending the practice of allowing FDA advisory boards to be filled with voting members who have financial conflicts of interest, the agency is taking an important step toward ensuring that the only interest advisory board members have when voting to approve a drug or device is that of the health and safety of American consumers" (Chicago Tribune, 3/22).
Rep. Rosa DeLauro (D-Conn.) called the rules "a step forward" but said she is "skeptical of their proposal given their recent track record of putting political and corporate interests above science." DeLauro added, "I am concerned that a closer inspection of the plan's details will reveal the loopholes that would render it toothless" (May, Newhouse/Newark Star-Ledger, 3/22).
Peter Lurie, deputy director of the Health Research Group at Public Citizen, said, "Conflict-of-interest guidelines are important, but they don't solve all the ills. There's an inordinate focus on clinicians and an insufficient focus on statisticians and epidemiologists, who tend to look at the data in a more dispassionate way. The clinicians always want more toys" (Los Angeles Times, 3/22).
Peter Pitts of the Center for Medicine in the Public Interest said the rules would reduce the quality of medical experts who serve on advisory committees. Pitts said, "The agency should not have to depend on the almost best and the kind of brightest" (Rockoff, Baltimore Sun, 3/22).
Pharmaceutical Research and Manufacturers of America officials said that they have begun to review the rules and plan "to respond in depth" (Chicago Tribune, 3/22).
NPR's "Morning Edition" on Thursday reported on the proposed rules. The segment includes comments from Hinchey; Jill Hartzler Warner, a senior policy adviser at FDA; and Lutter (Silberner, "Morning Edition," NPR, 3/22).
Audio of the segment is available online.