Are the scientists who recommend approval of drugs for public use too close to the pharmaceutical industry? Some members of Congress would like to find out.
U.S. Senator Mike Enzi, R-WY, Chairman of the Senate Health, Education, Labor and Pensions Committee and Senator Edward M. Kennedy, D-MA, Ranking Member of the Committee, have asked the Government Accountability Office (GAO) to review the Food and Drug Administration’s practice of providing conflict of interest waivers to members of its scientific advisory committees. Panel members on these committees are charged with recommending approval of drug and medical devices for public use.
Enzi and Kennedy were joined in the request by Senator Richard J. Durbin, D-IL. Senator Durbin is the Assistant Democratic Leader. In their letter, they say “We are concerned about the process that supports FDA’s decisions to waive conflict of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors.”
Panel members are meant to provide the FDA with unbiased, independent, and professional advice. They are required to be free of conflicts of interest concerning any products they recommend for approval. However, the FDA can grant a waiver if they feel that an expert’s participation is necessary, the financial interests are so small so as not to affect the individual’s service, or if the need for the expertise outweighs the potential conflict due to financial interest.
In the letter to David M. Walker, the Comptroller General, the Senators lay out the FDA’s charter in regards to drug approval. “The Food and Drug Administration (FDA) has the important responsibility of ensuring that the drugs, medical devices, vaccines, and other products used by the American people are safe and effective. The scientific advisory committee system at the FDA is meant to provide the agency with unbiased, independent and professional advice on general scientific matters and issues related to the particular products or classes of products. The scientific expertise provided by the advisory panels is critical to FDA’s ability to fulfill its mission of protecting public health.”
“We are concerned about allegations with regard to FDA’s use of waivers of the conflict of interest requirements,” the Senators continued. They provided two examples of such potential conflicts of interest. The first concerned the FDA’s advisory panel on the safety of Cox-2 inhibitors (such as Vioxx), where nearly one-third of the members received a waiver. The second example described allegations currently under review that one member of a panel considering the safety of silicone-gel breast implants received payments (either directly or indirectly) from the device industry.
“These practices appear to have undermined the public’s faith in the objectivity and fairness of FDA’s advisory committees,” the letter stated. “Further, there are questions about transparency in FDA’s procedures for forming advisory committees and granting waivers.”
The Senators asked the GAO to examine the issue and address the following questions, among others:
·Has the proportion of waivers grown over the past decade? How many of these waivers are for voting rather than non-voting panelists?
·What process exists for determining if a waiver should confer voting or non-voting status?
·Is there evidence that waivers influence voting? For example, is a member with a financial interest more likely to vote for the product under review (or against it) than a member without a financial interest?
·FDA’s decision to grant a waiver is often based on the need for the individual’s expertise. What barriers exist to identifying qualified individuals without conflicts?
·How does the FDA screen individuals it is considering for appointment to advisory committees for conflicts of interest? What procedures does the FDA have in place for identifying alternative individuals with minimal or no potential conflicts?
·Are the agency’s current disclosure statements transparent and appropriately detailed? How does FDA balance the needs for privacy and the requirements of FOIA (The Freedom of Information Act) versus the need for public disclosure of waiver agreements?
According to Craig Orfield, Spokesman for the Health, Education, Labor and Pensions Committee, the GAO generally takes several months to respond to a request of this type. While no decision has been made to hold hearings on this topic, he left open that possibility.