FDA's Advisory Committees: Legal Implications of Procedural Irregularities and Scientific Disagreement

Abstract

This paper focuses on the central role that advisory committees play in FDA’s regulation of new and existing drugs. Part I of the paper reviews the ‘ideal’ role of advisory committees: the authority for creating advisory panels, how they are regulated, what part they were designed to play, and the agency’s legitimate statutory and regulatory powers to ‘shape’ expert panels. Part II explores problems with the system, including the problem of conflicts of interest, of “packaging science,” and the susceptibility of committees to gamesmanship by interests seeking the legitimation benefits of scientific consensus. Part III categorizes and describes the various ways the ideal system breaks down, illustrated with recent examples of each in the context of drugs and devices. How is the process susceptible to forms of manipulation that undermine the quality of committee decisions? For example, the decision whether to convene an advisory committee meeting, through the selective presentation of evidence, by requesting re-hearings on issues when the committee makeup changes? Under what circumstances has the agency chosen to depart from committee recommendations? Part IV asks what this means for courts reviewing agency decisions when these warning signs are present, or when FDA simply disagrees with a committee decision. Ultimately, plaintiffs have not been successful in challenging agency regulatory decisions despite suspicious advisory committee procedures, although the courts are willing to override FDA in cases of egregious interference. Finally, Part V briefly describes how changes to the advisory committee process could improve the quality of agency decision-making, and how cracking down on some of these practices may paradoxically undermine the effectiveness of the program in other respects. For instance, adopting stringent conflict standards inevitably shrinks the pool of suitable experts.