The Food and Drug Administration unveiled new, tougher conflict of interest rules yesterday (Aug 4). Key among the regulations was one that prohibits physicians or researchers who have more than $50,000 worth of financial interests in pharmaceutical or medical device companies from offering expert advice as members of FDA advisory panels.

The new rules, issued in one draft guidance and four final guidance documents, also state that the FDA will publically release briefing materials pertaining to advisory committee meetings no later than 48 hours before the meeting occurs, and that votes taken at these meetings will occur simultaneously rather than sequentially, avoiding the potential for one vote to affect the next. The FDA also claims to have made its Web site more navigable so that the public can easily access information relating to advisory panels.

"It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent," said Randall Lutter, FDA's deputy commissioner for policy, in a statement from the agency. "Today's announcement strengthens our processes."

The guidances were issued in response to a law that, in part, required the FDA to progressively cut back on the number of conflict of interest waivers it issues to advisory panel members who report financial interests but posses "essential expertise." The current rules do allow for such waivers to be granted for potential panel members who report less than $50,000 in pertinent financial interests.

Merrill Goozner, director of the Integrity in Science Project at the research watchdog group Center for Science in the Public Interest, said that the new rules are a step in the right direction. "[The FDA is] eliminating people with gross conflicts of interest," he said. "That's a start."

But Goozner said that while the new FDA conflict rules are welcomed, the agency can do more to address conflicts of interest and other issues surrounding drugs and health care such as post-market monitoring and comparative effectiveness research. "[The new conflict rules] establish some interesting precedents and we look forward to continuing to push [the FDA] to further toughen the rules," he said. "There's just a whole host of issues that get wrapped up into making our health care system more effective and efficient."