Avandia Meeting Spurs New Scrutiny Of FDA Conflict-Of-Interest Screening
Revelations about speaking and consulting agreements between two FDA advisory committee members, Avandia maker GlaxoSmithKline and Actos maker Takeda, suggest the agency may need to further refine its conflict-of-interest screening procedures to ensure a public perception that it is receiving independent advice from outside experts
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In final guidance, the agency has rejected calls by the advocacy group Public Citizen to allow committee members to question open public hearing speakers on their finances.
The FDA advisory committee re-review of cardiovascular safety risks with GlaxoSmithKline's Avandia (rosiglitazone) will not end calls from agency critics to create a separate drug safety center. However, the transparency of internal scientific disputes on display at the July 13-14 meeting and the committee's recommendations could take some ammunition away from those who assert the Center for Drug Evaluation and Research has given short shrift to safety issues
Agency increases number of voting members for the meeting of the Endocrinologic and Metabolic and Drug Safety and Risk Management Advisory Committees to 33, up 10 from 2007. Half of the committee's voting members also participated in the first review of rosiglitazone's postmarketing safety.