Blog | Monday, August 4, 2008

FDA's new conflict-of-interest guidelines

Seems like everyone is getting on the conflict-of-interest bandwagon when it comes to drug companies.

New FDA guidelines prohibit the experts who advise during committee meetings to participate if they, their spouse or minor child have more than $50K financial interest in the companies that will be affected by their actions at the meeting.

Below $50K, the expert may get a waiver by the FDA to participate, but only if his or her input is deemed essential. The number of waivers given will be limited, and FDA will post on its Web site, in advance of the meeting, the reasons for each waiver.

Other changes:

-Advisory committee members must now vote all at once, insted of one-at-a-time. the aim is to avoid "momentum" that could sway people to vote in line with those who preceded them.

-Votes will be immediately announced at the meeting.

-Committee member votes will be posted on the FDA Web site.

-FDA will post the background materials it gives to committee members on its Web site at least 48 hours before the meeting starts.

What do you think of these guidelines? Is $50K a reasonable cutoff? How difficult is it to find experts who have little or no financial interest-- as from consulting or speaking fees-- in these companies? Do the voting and waiver rules go far enough to ensure transparency?