Vioxx and the FDA Advisory Committees: Yesterday, Today, and the Search for Tomorrow

For marketed drug products, the FDA has traditionally acted unilaterally when the risk/benefit calculation for drug approval has been undermined. Today, as the agency's credibility in protecting the public is coming under repeated attack, the advisory committee meeting is providing a variant approach that is another step in the growing importance of advisory committees at the FDA. The advisory committee process increases the transparency of the scientific debate, and the openness demystifies the process. Passions are tempered. The process forces a dialogue on the known facts, and it exposes the voids of data. Transparency stabilizes the process. Nevertheless, the advisory committee meeting remains only one element in the decision-making process. Because the FDA remains legally responsible, it controls that process, including the timing of the meetings, the preparation of briefing documents, and the ultimate decision.

For the COX-2 selective inhibitors, this process permitted thoughtful analysis of the risks and the benefits of the drugs. Its expedited scheduling helped diffuse the matter. Further, the meeting helped provide an answer to the often-unanswered question that arises in product liability suits ' what was the invisible man in the courtroom (FDA) thinking? A review of the process shows that the FDA improved its use of this tool, and that its use has proved invaluable, historically. If the FDA continues to come under attack for failing to protect the public from specific drugs, more such meetings will be held, and a strategy for dealing with them is necessary. Accordingly, it is useful to trace the past use and project future use.