The US Food and Drug Administration (FDA) has moved to stave-off a political firestorm by proposing new conflict of interest rules that would limit the ability of medical experts with financial interests in pharmaceutical companies to sit on the agency's influential scientific advisory committees.
The proposed rules would prohibit physicians or scientists (and, by extension, their immediate families and employers) who have over $50000 in financial ties to a company over the previous 12 months from participating on a panel reviewing one of that company's products. Medical experts who have received less than $50000 in the previous year could participate in the discussion but would not be allowed to vote.
Several grey areas remain unresolved. Waivers, which the FDA has routinely issued in the past, would still be allowed for experts with under $50000 in financial ties, if the “need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved.” Financial ties would include things such as stocks, research grants, licensing revenues and consulting or speaking fees. Grants from a pharmaceutical firm to an academic researcher's home institution would be reviewed by the FDA to determine whether they should also be included.
By contrast, Canada has no hard rules governing exemptions or waivers. Experts with conflicts are allowed to sit on panels without a formal waiver process. But conflicts are publicly declared and Health Canada says panel chairs can place limits on an individual's involvement. It's long been argued that Canada needs such a degree of latitude because of its limited pool of available experts.
The new US rules are the product of a year-long internal review of the FDA's Advisory Committee Meeting system, which the agency uses to garner expert advice on scientific issues surrounding drugs (CMAJ 2006;175[1]:23-4). Typically, about 20% of the 35–40 new drugs approved by the FDA each year are subject to external panel review. Advice provided by the FDA's 16 drug committees and 32 other advisory panels is not binding. But the agency has rarely deviated from their recommendations.
The FDA struck the review in response to a raft of Congressional bills now working their way through the US legislative process, and widespread criticism that the agency's credibility had been compromised. The impetus for change became all but inexorable last September when a committee convened by the highly influential National Academies (a Congressionally chartered scientific advisory body comprised of the Institute of Medicine, the National Academy of Sciences, the National Academy of Engineering and the National Research Council, and charged with advising the government on science and health policy issues) released a report, The Future of Drug Safety, that recommended an overhaul of the agency's structure, management and “culture.” One recommendation called on the FDA to limit conflicts of interest by requiring “a substantial majority [i.e, 60%] of the members of each advisory committee be free of significant financial involvement with companies whose interests may be affected by the committee's decision.”
“FDA's credibility is its most crucial asset,” the report noted, adding that controversies over the independence of advisory committee members “have cast a shadow on the trustworthiness of the scientific advice received by the agency.”
FDA Acting Deputy Commissioner for Policy Dr. Randall Lutter stated in a press release that the new conflict guidelines will make the advisory committee process “more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees.”
But Centre for Science in the Public Interest's Director of Integrity in Science Merrill Goozner says that while the changes “are a start,” they fall well short of either a complete ban or introducing the sort of cultural changes recommended by the Institute of Medicine.
“The Institute of Medicine said there was a cultural problem at the FDA, in which, rather than seeing themselves as being there to protect the public from unsafe or effective drugs, they're there to help the industry bring new drugs to market. That's really not their statutory responsibility.”
Goozner added that a complete prohibition against conflicted medical experts would “be a signal that they understand that there is both a public perception, and an internal problem, about the culture of the FDA.”
The FDA hopes to issue final guidelines “as soon as possible,” says agency spokesperson Heidi Rebello. — Wayne Kondro, CMAJ