Healthy Skepticism Library item: 5760

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Publication type: Journal Article

Hopkins Tanne J
FDA to clarify rules on advisory committee members
BMJ 2006 Aug 5; 333:(7562):278
http://bmj.bmjjournals.com/cgi/content/short/333/7562/278?etoc%3e

Abstract:

The US Food and Drug Administration announced last week that it is to develop guidelines to clarify the relationships between members of its advisory committees and pharmaceutical companies. The aim is to make advisory committee processes more effective and to reassure the public about the integrity of the process.

There will be a period for public comment on the proposed new rules.

Some scientists with industry ties are granted waivers to allow them to participate in advisory committees, but the process is unclear.

The advisory committees provide expert advice and recommend whether the agency should approve new drugs and devices. The FDA usually, but not always, follows the committees’ advice.

Some critics say all experts with ties to industry should be excluded. Many academic researchers have no ties to industry, and they could serve on the advisory committees, say critics such as Merrill Goozner of the Center for Science in . .