FDA Cracks Down On Conflicted Interests

Recommendations produced by FDA advisory committees -- the doctors, scientists and experts convened to evaluate drugs and treatments -- often determine agency policy. In recent years, the committees have been criticized for featuring members with extensive financial ties to companies involved in matters being evaluated.

Conflicts of interest aren’t always as clear as they seem. In an age of shrinking federal research budgets and ever-more-common collaborations between industry and acadedemy, it can be hard to find researchers who don’t have some sort of commercial connection. The extent to which financial ties influence an individual’s recommendations is also hotly debated.

At the same time, the influence of financial interests can be subtle -- an unconscious predisposition that skews how data is interpreted, a reflexive prejudice against alternative positions. Moreover, the mere perception of conflicted interests can be enough to erode public confidence in what are expected to be the nation’s most trustworthy and independent health advisors.

In a radical rule change proposed yesterday, the FDA seems to have struck a balance between all these concerns:

Expert advisers to the government who receive [more than $50,000] froma drug or device maker would be barred for the first time from votingon whether to approve that company’s products under new rules announcedWednesday for the F.D.A.’s powerful advisory committees. [...]

A “significant number” of the agency’s present advisers would beaffected by the new policy, said the F.D.A. acting deputy commissioner,
Randall W. Lutter, though he would not say how many. [...]

“The $50,000 threshold is something that we think strikes anappropriate balance between” getting smart advisers and reassuring thepublic that their advice is not tainted, Dr. Lutter said.

F.D.A. Rule Limits Role of Advisers Tied to Industry [New York Times]