FDA Announces Steps to Improve Advisory Committee Processes

The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with recommendations of the Institute of Medicine. The measures include proposed new guidance or procedures on advisory committee voting, on disclosing information on conflicts of interest, and on security and appropriate conduct for participants at meetings. Other improvements include greater clarity to FDA’s advisory committee Web site, which can be found at http://www.fda.gov/oc/advisory/default.htm.

“One of FDA’s strengths is that we routinely enlist the nation’s leading experts to give us public advice on complex medical and scientific issues,” said Randall Lutter, Ph.D., deputy commissioner for policy. “The new steps we’re taking further enhance the transparency and reliability of our advisory committee processes.”

A draft guidance document being issued today recommends advisory committees adhere to a process of simultaneous voting, in which all members vote at once.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 The draft guidance document is available at http://www.fda.gov/oc/advisory/votingguidance.html.

A second draft guidance issued recently lays out recommended changes to the process of public disclosure of financial interests that create conflicts of interest for advisory committee members. The new draft guidance makes the process more transparent and consistent by having all advisory committee members publicly disclose interests for which a waiver is granted. The draft guidance also includes redesigned disclosure and waiver templates that are clearer and easier for the general public to understand. The draft guidance document and redesigned templates are available at http://www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html.

FDA also has formalized operating procedures designed to ensure appropriate security and promote proper decorum and public conduct at advisory committee meetings. They are intended to help ensure that meetings proceed in an orderly fashion and that the work of the committees is not impeded, but that the right of free speech is also protected.

In addition, FDA has improved its Web page on advisory committees by providing better access to information about waivers granted for conflicts of interest. This Web page provides current information about upcoming advisory committee meetings and other updated information related to FDA’s advisory committee processes. The Web site is at http://www.fda.gov/oc/advisory/default.htm.

Finally, the FDA has recently posted the names of outside experts that it has named to a new risk communication advisory committee to make recommendations to FDA about how best to communicate the risks and benefits of FDA regulated products. More information about this advisory committee and the list of members can be found at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01739.html.

FDA’s policies on advisory committees continue to be informed by new studies on conflicts of interest. The agency asked a consultant, Eastern Research Group, to study 16 recent advisory committees. The report highlights the difficulty of assembling highly qualified experts who are free of conflicts and finds that those who have received waivers appear to be significantly more qualified than those who have not received waivers. The full report is available online at http://www.fda.gov/oc/advisory/ERGCOIreport.pdf.

So far this year the agency has convened 47 meetings of expert independent advisory committees to advise FDA on topics such as new gene therapies and the safety of children’s cough and cold medicines.