In March, FDA announced new draft guidance that would implement more-stringent criteria for evaluating potential conflicts of interest among members of advisory committees.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 addressedand with consistencybut I am concerned about this particular guidance's impact."
Should the draft guidance be finalized as it is currently written, medical device manufacturers may need to reevaluate their existing relationships with some consultants.
"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."
"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 hireor not hireconsultants, so as to balance the need of the industry for adequate expertise with the need for the agency to have expertise available."
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 financial 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.
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.