Wednesday, December 05, 2007

Should FDA give waivers to panel members who have conflicts of interest?

Two recent analyses offer opposing views about whether the Food and Drug Administration (FDA) should give waivers to outside experts, allowing them to participate on important government panels despite conflicts of interest.

The Food and Drug Administration (FDA) relies on expert scientists as advisers on a host of panels, which strongly influence the agency's oversight of important issues ranging from food safety to the approval of new drugs and medical equipment. The advisers may have conflicts of interest, such as having received research funding from a company whose products are being reviewed by the panel. In some cases, FDA grants waivers to the rules prohibiting conflicts of interest, on grounds that the conflict is minor or that the adviser offers unique expertise that outweighs the concern about conflict.

Last spring, the FDA proposed new rules that would limit such waivers. According to a summary from the Center for Science in the Public Interest (CSPI): "Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."

However, more recently FDA has emphasized the value it places on waivers, arguing that it would be difficult to replace the expertise of many advisers who have conflicts of interest. FDA cited a report (.pdf) from the Eastern Research Group, which reviewed a number of panels and argued that FDA might not be able to make do without the experts who received waivers (the report's first author, Nyssa Ackerley, is a former student of the food policy program here at the Friedman School).

By contrast, according to CSPI's Integrity in Science newsletter, a coalition of public interest groups including CSPI analyzed the same data and reached the opposite conclusion:
For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not.
Do you think FDA should grant waivers to conflict of interest rules to recruit expert panelists who would otherwise be ineligible? Comments are open.


Anonymous said...

Of course, it shouldn't grant waivers, but, especially given the current environment in Washington, I'm not optimistic the practice will stop. It's hard to believe that the only "experts" available are those that just happen to have financial ties to the outfits they're seeking to regulate.

Nat said...
This comment has been removed by the author.
Nat said...

Actually, I think that it's not so hard to believe that many "experts" have financial ties to the companies. People devoted to specific topic will have sought funding from the appropriate sources, and it's not unreasonable to believe that they have either been funded or been denied funding by the company that has an interest in the topic at hand.

In any case, I would like to argue "no" to your question, but knowing that it's not that simple. My questions to you, keeping in mind that I do not know too much about the FDA panels and how they are run, are how big are the panels, how do the panels reach a decision, and what is the proportion of "experts" that have conflicts of interest.

It is a real danger to have the company influence judgement on approval or regulation decisions. Another issue is also the regulation of research funding by these companies, as this funding may not only influence the FDA panels but also create experimental biases, but that is another discussion....

By the way, I came across this blog from your faculty page at Tufts. Very interesting, and I'm quite appreciative of the discussions and information sources in your posts.