Outside experts who have more than $50,000 in ties to companies regulated by the FDA would be barred from advising the agency under new draft guidelines announced on Mar. 21. But accompanying this proposal is a loophole that would allow the FDA commissioner to grant some exceptions.
Under the guidelines, those who have received less than $50,000 from companies within the previous year might be allowed to participate in panel discussions but could not vote. Generally, only those members with no potential conflicts would be eligible to participate as voting members.
Lily K. Jung, MD, the consumer representative on the FDA Peripheral and Central Nervous System Drugs Advisory Committee, said in an e-mail that nonvoting members can still be influential. “If you have an individual who is a thought leader…others might be swayed by his or her opinion.” She said that in her experience, however, most members have less than $10,000 in financial ties.
The announcement follows increased criticism from consumer groups and members of Congress who claim that the panelist investments as well as their consulting and speaking arrangements can influence the recommendations they make to the FDA. A 2006 Institute of Medicine report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” recommended that the FDA adopt stronger policies to minimize conflicts of interest among outside advisers.
Representative Maurice Hinchey (D-NY), who has proposed legislation to end the FDA practice of offering conflict of interest waivers to its board members, said he was pleased with the tougher rules. “…the agency is taking an important step toward ensuring that the only interest advisory board members have when voting to approve a drug or device is that of the health and safety of American consumers,” he said in a news release.
However, Dr. Jung, a neurologist at the Seattle Neuroscience Institute and Swedish Medical Center, said the reality of limiting membership to experts who are entirely free of conflicts is more complicated. “If you are an academician, if your department gets research funding from a pharmaceutical company, even if you have nothing to do with the project, you are asked to report it. It is extremely difficult to monitor how much the people you are affiliated with are associated with a particular company.”
The FDA document on the new draft guidelines are available at www.fda.gov/oc/advisory/waiver/ coiguidedft.html. The guidelines will not become final until the end of a 60-day public comment period. To submit electronic comments on the proposed guidelines, visit www.regulations.gov or www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number 2007D-0101.