US Senators Ask GAO to Review FDA’s Conflict-of-Interest Policy

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http://www.newsinferno.com/storypages/9-27-2005~006.html

> US Senators Ask GAO to Review FDA’s

> Conflict-of-Interest Policy

> Date Published: September 27, 2005

> Source: Newsinferno.com News Staff

>

> 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 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 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 M. , 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 -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:

>

> a.. Has the proportion of waivers grown over the

> past decade? How many of these waivers are for

> voting rather than non-voting panelists?

> b.. What process exists for determining if a

> waiver should confer voting or non-voting status?

> c.. 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?

> d.. 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?

> e.. 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?

> f.. 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.

>