FDA Proposes Tougher Criteria for Advisory Committee Membership

April 1, 2007

7 Min Read
FDA Proposes Tougher Criteria for Advisory Committee Membership

Late last month, FDA announced new draft guidance that would implement more-stringent criteria for evaluating potential conflicts of interest among members of advisory committees. Under the guidance, advisers who receive money from a drug or device maker would be barred from voting on whether to recommend approval of that company's products. Advisers receiving more than $50,000 in disqualifying financial interests would be barred from participating in meetings altogether, regardless of the need for that person's expertise.

"The bottom line is that device companies will be at risk of having their new, sophisticated technologies reviewed by advisory committees that lack the expertise necessary to understand those technologies," says Bradley Merrill Thompson, a member of the healthcare and life sciences practice of Epstein, Becker & Green (Washington, DC). "Unfortunately, knowledgeable experts are a scarce resource."

Such concerns are being echoed by some industry members.

"I am concerned about the impact this level of restriction will have on device panels," says Susan Alpert, PhD, MD, senior vice president and chief quality and regulatory officer at Medtronic Inc. (Minneapolis). "Unlike drug panel recruitment, there are many fewer doctors with experience and competence in device development and testing to sit on FDA advisory panels. I agree that conflict of interest is an issue that must be addressed—and with consistency—but I am concerned about this particular guidance's impact."

Medtronic's Alpert: Restriction concerns.

Industry association AdvaMed (Washington, DC) reports that its technology and regulatory affairs group is currently reviewing the draft advisory committee guidance. The association plans to submit comments to FDA by the prescribed deadline of May 21. Prior to submitting its comments, the association is not issuing formal comments on the matter.

Should the draft guidance be finalized as it is currently written, medical device manufacturers may need to reevaluate their existing relationships with consultants who may also serve as advisory committee members.

"When a company is preparing to start a clinical evaluation, the prudent approach to minimize the impact of the new guidance would be to determine whether any of the experts being considered for participation are currently advisory panel members," says Glen Paul Freiberg, president of RCQ Consulting (Rancho Santa Fe, CA). "Even if they have a defined term of office, these terms could be renewed. So my recommendation is to avoid those individuals. Of course, one of the participants could later be asked to serve on a panel, so it would also be prudent to advise company-retained experts that such service could create a conflict of interest prohibiting them from serving at a panel meeting at which the sponsor's product is discussed."

Freiberg: Strategies for adapting.

"Unfortunately, this is one of those instances where action unilaterally by a single company is unlikely to improve matters much," Thompson says. "If a given company avoids entering into consulting agreements with experts who it believes will be necessary to participate on an FDA committee, a competitor might well swoop in and retain those consultants. The only effective solution will be a collective one in which the companies come together under the umbrella of a trade association and develop some best practices for how they will hire—or not hire—consultants, so as to balance the need of the industry for adequate expertise with the need for the agency to have expertise available."

Thompson says that although an obvious solution to the issue would be for a company to keep its relationships with consultants below the thresholds stated in the proposed guidance, those thresholds are so low that such a strategy may not be practical.

Currently, FDA screens all prospective advisory committee participants before each meeting to determine whether there is potential for a financial conflict of interest. Under current practice, the agency may grant a waiver when certain criteria are met. For example, waivers have traditionally been granted when the need for an individual's expertise outweighs the potential for a conflict of interest.

The new guidance would eliminate the possibility of such waivers in cases in which an individual received more than $50,000 in disqualifying financial interests. Individuals with financials interests of $50,000 or less could be recommended to participate as nonvoting members, but only individuals with no potential conflicts would be eligible to participate fully in meetings.

FDA defines financial interest as the potential for gain or loss to a person (or their family and outside affiliations) as a result of the government's action on a particular topic. Such interests include stock ownership and related research and consulting arrangements.

"FDA is committed to making 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," said Randall Lutter, PhD, FDA's acting deputy commissioner for policy. He says the new draft guidance document would provide more consistency in the consideration of who is eligible to participate in advisory committee meetings.

The new guidance would replace a document issued in 2000 that attempted to outline a set of variables that could be used to reach a decision regarding advisory committee participants. However, due to the complexity of the original guidance, FDA officials have found it difficult to achieve consistent results that the public can readily understand.

Advisory committees provide FDA with independent advice from outside experts regarding the approval of drugs and medical devices. Although FDA's ultimate decisions often coincide with committee recommendations, such recommendations are not binding.

"In theory—statutes aside—disclosure, rather than disqualification, can be an adequate way to deal with a conflict of interest," Thompson says. "So long as the adviser completely and fully discloses what his or her interests are, the agency can take those interests into account when evaluating the content of the advice. Remember, we are not really talking about decision-makers. Even full votes of these committees are merely advice. So these people are not making policy, but merely offering their expert opinions to the agency. In those instances, the agency doesn't so much listen to the ultimate recommendation as it does to the explanations and reasoning that lead to the ultimate recommendation."

However, Thompson acknowledges that FDA does have to manage appearances. "It will not do for the public to lose confidence in the process because of perceived conflicts of interest," he says. "If the agency uses an advisory committee member to educate the agency on general principles of scientific matters, without discussing a specific application, the impact of the conflict of interest statutes might be avoided. This is not a panacea, though, because the agency will sometimes need help reviewing a specific application."

While FDA's new guidance stems largely from public perceptions of conflicts of interest related to advisory committees, Freiberg notes that the advisory panel system itself may be misunderstood by the public. "Many in industry and FDA readily admit that this system is used as support for FDA decisions on controversial matters—not to help FDA make the decisions," he says. "FDA's Center for Devices and Radiological Health has acted on this knowledge by creating the de novo 510(k) system. When devices without a predicate come forth and there are no issues that would be controversial to the public, a downgrade from Class III to Class II has become the norm. Conversely, where there may be public concern either from risk, political viewpoints, or newness of a concept, a panel may be convened even for 510(k) products.

"While panel meetings can provide valuable scientific feedback to FDA, such feedback is generally not necessary, as FDA has the scientific expertise to understand clinical trials and the assessment of the resulting data," Freiberg adds. "Individual product expertise is rarely needed to understand a sound scientific presentation."

© 2007 Canon Communications LLC

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