FDA Should Give Presentations at Advisory Committee Meetings, Petition Says

Experts from the FDA should be required to give presentations at all advisory committee meetings to ensure unbiased information is presented, according to a petition filed by Public Citizen.

Product sponsors cannot be relied upon to provide unbiased information, and could deny advisory committee members knowledge necessary to make appropriate decisions, the group said. The petition asks the FDA to have agency staff provide orals presentations on the reviewed products, including safety and efficacy assessments, at every committee meeting.

The FDA did not present at 49 of the 275 drug advisory committee meetings between 1997 and 2006, according to a study published in the December 2006 issue of The Lancet. The agency does provide briefing materials to advisory committee members before the meeting, but the members may not evaluate the information in detail, Public Citizen said.

Advisory committee members cannot judge a product independently if they are “poorly and selectively informed and thus more likely to be more familiar with the drug sponsor’s point of view than that of the FDA,” the petition says.

The petition can be seen at www.citizen.org/publications/release.cfm?ID=7530.