FDA Advisory Committees Would Get Patient Influence Under Hagan Bill
Executive Summary
Adjusting advisory committee conflict of interest rules has emerged as a high-priority issue in reauthorizing the drug user fee program, and several bills already propose loosen those rules. Sen. Kay Hagan’s draft FDA reform legislation may prove to be the most loosening proposed to date.
Sen. Kay Hagan’s draft FDA reform legislation includes several provisions aimed at expanding the pool of possible participants in agency advisory committees.
Adjusting conflict of interest rules for FDA advisory committees has emerged as a high-priority issue to be addressed by Congress in the reauthorization of the drug user fee program, and several bills already have been offered that attempt to loosen rules intended to keep the panels impartial.
Hagan’s bill may prove to be the most loosening proposed to date.
The draft bill, a copy of which was obtained by “The Pink Sheet,” allows for conflict of interest waivers to be granted if needed to give the advisory committee “essential expertise, such as for rare diseases or emerging technologies” or if the financial interest in question is not likely to affect the committee’s integrity.
A waiver also would be allowed if “the need for services of the individual on the committee outweighs the potential for a conflict of interest created by the financial interest involved,” according to the draft bill.
The language could revive concerns about so-called “intellectual conflict of interest,” where the rules create advisory committees with mostly experts in favor of the drug in question.
FDA faced criticism related to the problem in 2009 when it reviewed Eli Lilly & Co.’s Effient (prasugrel) (Also see "Prasugrel Intellectual Bias: FDA Makes Changes, Congress Demands Answers" - Pink Sheet, 9 Mar, 2009.).
How To Fill Vacancies
Rare disease advocates and others have complained that the conflict of interest rules disqualify many of the most knowledgable scientists and clinicians in some disease areas, particularly for orphan products.
The rules have made it difficult in some cases for FDA to fill committee vacancies. But consumer advocates argued recently they were fine as is and there are enough unconflicted experts.
Rep. Michael Burgess, R-Texas, has introduced a bill that would allow FDA to consider the type, nature and magnitude of financial interest when assessing potential conflicts.
Sen. Amy Klobuchar, D-Minn., also added conflict of interest rule changes to a device reform bill that would only subject advisory committee members to the Ethics in Government Act of 1978 (Also see "PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter" - Pink Sheet, 31 Oct, 2011.).
Hagan’s draft bill also would adjust the make-up of advisory committees somewhat by requiring two or more medical or scientific experts be selected from a pool submitted by relevant patient advocates and disease organizations.
Current law allows consumer, scientific and trade groups to nominate experts for advisory committees, but does not mention patient and disease organizations.
Hagan’s draft bill would also create two rapid approval mechanisms for drugs. The legislation would also create new FDA positions in a effort to speed product reviews.