Saturday, March 31, 2007

FDA addresses conflicts of interest on its advisory boards

Shankar Vedantam of the Washington Post wrote: Under the [proposed] new rules, any scientist or physician who has had $50,000 or more in financial ties to a company over the past 12 months, including stock or consulting arrangements, would be barred from panels [of the FDA] evaluating that company's products. Those who have received less than $50,000 in the previous year might be allowed to participate in the discussion but could not vote.

Randall Lutter, the FDA's acting deputy commissioner for policy, was quoted: "We are very interested in ensuring we have the best possible access to scientific experts. At the same time, we seek to ensure we have the fullest public confidence in the integrity of our advisory committee process."

Curiously, although Lutter's comment is directed to the problem of an expert favorably reviewing the expert's own products, the comment could equally well be applied to peer to patent, wherein an expert at company A might UNFAVORABLY review the patents of his competitor, company B.

IPBiz mentioned the FDA issue before: Conflicts of interest at the FDA

See also

**Of grants,

Lutter and Warner said the $50,000 figure would not apply to research grants made by pharmaceutical companies to universities where the scientists work, only to grants given directly to experts.

There's something here for CIRM to think about.


Post a Comment

<< Home