New Steps to Improve Advisory Committee Processes
FDA has announced several steps to strengthen its advisory committee processes in ways consistent with recommendations of the Institute of Medicine. So far this year, FDA has convened 47 meetings of expert independent advisory committees to advise the agency on topics such as new gene therapies and the safety of children’s cough and cold medicines.
“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., FDA's Deputy Commissioner for Policy. “The new steps we’re taking further enhance the transparency and reliability of our advisory committee processes.”
- A new draft guidance document recommends that advisory committees adhere to a process of simultaneous voting, in which all members vote at once.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. The document is available at http://www.fda.gov/oc/advisory/votingguidance.html.
- A second draft guidance lays out recommended changes to the process of public disclosure of financial interests that create conflicts of interest for advisory committee members. The guidance includes redesigned disclosure and waiver templates that are clearer and easier for the general public to understand. The document and redesigned templates are available at http://www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html.
- New operating procedures aim to ensure appropriate security and promote proper public conduct at advisory committee meetings. The procedures 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.
- Improvements to FDA's advisory committee Web page provide better access to information about waivers granted for conflicts of interest. This page also includes information on upcoming advisory committee meetings and other resources. The Web site is at http://www.fda.gov/oc/advisory/default.htm.
- FDA has recently posted the names of outside experts that it has named to a new risk communication advisory committee. These experts will make recommendations to the agency about how best to communicate the risks and benefits of FDA-regulated products. More information about this advisory committee is 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.
Date Posted: November 19, 2007
