FDA to Improve Advisory Committee Processes

The FDA is announcing several steps to strengthen its advisory committee processes, consistent with recommendations of the Institute of Medicine.

The measures include proposed new guidance or procedures on advisory committee voting, disclosure of information on conflicts of interest and security and appropriate conduct for participants at meetings. Other improvements include greater clarity to FDA’s advisory committee website, the agency said.

A draft guidance document issued last week recommends advisory committees adhere to a process of simultaneous voting, in which all members vote at once. The results of the vote would be announced immediately. How each member voted would be part of the public record. The draft guidance document is available at www.fda.gov/oc/advisory/votingguidance.html.

A second draft guidance issued recently lays out recommended changes to the process of disclosing financial interests that create conflicts of interest for advisory committee members and is available at www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html.

Finally, the agency has recently posted the names of outside experts that it has named to a new risk communication advisory committee to make recommendations to the FDA about how best to communicate the risks and benefits of FDA-regulated products.