Issue: 57 Food and Drug Law Journal 293-322 (2002).
This article addresses the difficulties faced by the Food and Drug Administration (FDA) as it attempts to locate "independent" experts to serve on drug and biologics advisory committees. As academic medical experts grow more dependent on private sources of funding, it is increasingly difficult for FDA to find scientists and physicians who are qualified to serve on committees and who can meet the agency's financial conflict of interest requirements. To cope with this problem, FDA has developed a system of waivers, allowing experts to serve on advisory committees if the need for their services outweighs the dangers posed by potential conflicts of interest. But waivers cannot resolve the underlying conflict, even if they provide the agency with a means of managing the problem. Consumer advocates, members of Congress, and the press have accused FDA of approving dangerous drugs or vaccines after relying on the recommendations of conflicted advisory committee members. This article traces the development of FDA's methods for evaluating experts' financial conflicts and considers whether the agency's current policies do enough to protect the integrity of the advisory committee process.