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

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, <i>ie</i>, 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.

14 minute read June 14, 2005 at 09:02 AM

By

Edward John Allera