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

By Edward John Allera

Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's (“FDA's”) failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (“NAIDs”). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, ie, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.

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.

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