FDA Proposes Limiting Conflict-of-Interest Waivers;
Consumer Groups To Push for Tougher Rules
In an effort to stave off tougher Congressional action, the Food and Drug Administration last week proposed limitations on the ability of scientists with ties to industry to serve on its influential advisory committees. The proposal would ban any scientist who earned over $50,000 in consulting, research or speaking fees in the previous year from serving on the committees, and prohibit those with lesser conflicts from voting. The new policy “should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process,” deputy commissioner Randall Lutter said.
Consumer groups criticized the proposed changes as not going far enough. The Center for Science in the Public Interest, which backs a total ban on individuals with conflicts of interest serving on advisory committees, blasted the FDA’s claim that the agency’s need for an individual’s expertise sometimes overrides financial conflicts of interest. “With 125 medical schools in the U.S., the FDA can easily find unconflicted advisers to staff its committees,” said Integrity in Science project director Merrill Goozner. The National Research Center for Women and Families said any scientists with financial ties to firms affected by the committee deliberations can influence the tenor of the discussions and therefore should be eliminated.
Other consumer groups plan to suggest to the FDA that if the agency wants testimony from conflicted experts, they should be limited to presenting their point of view at the public portion of the meeting, which is the current process for consumer and patient advocacy groups. Consumer groups are also concerned that the draft guidance did not address the lack of balance on many FDA committees, where many rosters lack sufficient expertise in drug safety, post-marketing surveillance, and epidemiology. The FDA will accept public comments on the proposed guidance for 60 days
Cancer Drug Advisory Committee Grants Waivers
If the new FDA draft guidance were in place, the Cellular, Tissue, and Gene Therapies Advisory Committee that meets this week would not allow three of its members to serve and more than half wouldn’t be allowed to vote. The committee, which will discuss the prostate cancer drug Sipuleucel-T, manufactured by Dendreon, granted waivers to 8 of its 14 members. Among them were Mary Horowitz, who received funding from Roche, the manufacturer of a competing prostate cancer drug; Derek Raghavan, who receives funding from competing manufacturers Aventis and Eli Lilly; and Dr. Howard I. Scher, who receives grant support from Aventis.
FDA Pushes for Higher Prescription Drug User Fees
Despite widespread consumer opposition to using drug- and device-industry user fees to fund the FDA, Commissioner Andrew C. von Eschenbach last week asked Congress to sharply increase the level of funding coming from industry fees. “The reauthorization of this law plays a significant role in FDA's continued ability to make drug therapies available to the American public in a timely fashion without sacrificing the quality of approval decisions,” he said. The FDA proposal asked for just $29.3 million for increased safety surveillance of recently approved drugs.
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