FDA drafts new rules for advisory panel waivers

While the Council of Medical Specialty Societies was putting the finishing touches on its new ethics code (see related article), the FDA proposed new rules that would air its advisory panels' conflicts of interest, rather than shrouding them in secrecy.

The FDA's advisory committees play a big role in approvals of new drugs and new indications. Because industry shoulders so much of the funding burden for drug studies, the experts on these panels can find themselves ruling on a drug made by a company that writes their paychecks--if only indirectly. So, the FDA often grants waivers so experts can still serve on a particular committee, as long as financial relationships are disclosed.

But when those waivers are released publicly, they hardly count as disclosures at all, because so much information has been blacked out by agency censors. The FDA knows what the relationships are, but it doesn't tell the rest of us.

That would change under the new proposal. The FDA wants to post the disclosure info online--and before the committee meeting in question.

Waivers could become more difficult to get as well, Commissioner Margaret Hamburg suggests in a letter to agency staff. Recommendations for waivers would need to be justified: How hard did staff search for other experts without conflicts? And waivers should be harder to come by for meetings where a specific product will be voted upon, as opposed to meetings aimed at an entire class of products, she writes.

- see the letter from Hamburg
- check out the draft guidance
- read the post at Pharmalot

Related Articles:
Doctors sign on to tough conflicts-of-interest rules
Pharma, academia ties difficult to unwind