22 March 2007

FDA regaining independence?

US health officials have proposed setting stricter standards for membership on US Food and Drug Administration advisory committees.

US health officials have proposed setting stricter standards for membership on US Food and Drug Administration advisory committees.

The biggest change bars anyone from serving on a committee who has a financial interest of $50 000 or more that could have an impact on the drug, device or other issue the committee is considering. Overriding this rule would require a special waiver. If such a waiver is granted, that person could attend meetings, consult and express his views, but could not vote.

In addition, anyone with a conflicting financial interest of less than $50 000 could sit on an advisory committee, but could not vote. There will be a 60-day comment period before the proposals take effect.

"Advisory committees have been subject to increased scrutiny," Randall Lutter, the FDA's acting deputy commissioner for policy, said during a teleconference. "There has been increased attention to advisory committee members' potential conflict of interest and how FDA reviews and allows waivers allowing participation in advisory committee meetings."

Serious changes advised
Lutter noted the changes were undertaken in response to last year's report by the Institute of Medicine, which found the FDA needed to make serious internal changes, including how advisory committee members were selected.

"The draft guidance establishes more stringent standards for deciding who can participate in an advisory committee meeting and who should be excluded due to a conflict of interest," Lutter said.

One expert called the FDA move a step in the right direction.

"This is a movement away from FDA's prior claim that you can't find sufficient expertise among people without conflict," said Dr Peter Lurie, deputy director of Public Citizen's Health Research Group, a consumer advocacy organization based in Washington, DC. "It is also a movement away from a growing trend in medicine, that you can manage conflict of interest."

Advisory committees are designed to provide the FDA with independent advice by outside experts on issues related to human and veterinary drugs, biological products, medical devices and food.

These committees usually include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be consulted as needed. The committees provide FDA officials with advice, but their recommendations are not binding. However, the FDA, which makes all final decisions on drug approvals and other matters in the US, usually follows the committees' advice.

Strikes a good balance
Lutter said he believed that the $50 000 limit strikes a balance among the needs of the agency for scientific input, the transparency of the process, and public confidence.

"The limit would cover financial interests over the proceeding 12 months and cover, for example, stock and consulting fees," he said.

According to Lutter, these new procedures will affect a significant number of people already serving on advisory committees. "It may cause some people to be disqualified," Lutter said. "At the same time, we are expanding our efforts to get people to serve on committees."

This new policy will simplify the process of selecting committee members, Jill Hartzler Warner, the agency's senior policy advisor and counsellor in the Office of Policy and Planning, said during the teleconference. "This will increase the transparency, clarity and consistency of the advisory committee process, and enhance public trust," she added.

Currently, the FDA screens all prospective advisory committee members before each meeting to determine whether the potential for a financial conflict of interest exists. Under law, FDA may grant a waiver when certain criteria are met, such as when the need for an individual's expertise outweighs the potential for a conflict of interest, Hartzler Warner noted.

Controversy on the increase
Controversy over FDA advisory board appointees has increased over the past few years, most notably over the approval and subsequent withdrawal of cox-2 inhibitor prescription painkillers.

According to a 2006 report in the New York Times, 10 of the 32 FDA advisory committee members who voted at that time to allow the continued sale in the United States of the three painkillers - Bextra, Celebrex and Vioxx - had previously acted as consultants for the drugs' manufacturers. If these members had not voted, the recommendations would have been for Bextra to be withdrawn and Vioxx to not be returned to the market, the Times said.

As it was, panel advisors with company ties voted overwhelmingly for Bextra to stay on the market and for Vioxx to return to pharmacy shelves. Celebrex would not have been affected.

Both Bextra and Vioxx remain off US drug store shelves, however. Vioxx was pulled in September 2004, after studies linked long-term use to cardiovascular trouble. Similar data prompted the withdrawal of Bextra from the market in April 2005. Celebrex remains available to consumers.

Conflicts ignored
A study published last April in the Journal of the American Medical Association added more fuel to the debate. In that study, researchers examined agendas and transcripts from all FDA drug advisory committee meetings listed on the agency's Web site as taking place between January 1, 2001, and December 31, 2004.

A total of 221 meetings held by 16 advisory committees were included in the analysis. In almost three-quarters (73 percent) of the meetings, at least one committee member or voting consultant disclosed a conflict, yet only 1 percent of committee members disqualified themselves from participation, the study found.

Lurie said he is concerned that, even after Wednesday's announcement, nonvoting members will still have some impact on FDA panels. But he believes that their status as nonvoting members will also become a kind of stigma that the voting members will take into account, he said.

In addition, this change will make recruiting people without conflicts of interest more desirable, according to Lurie. "And that's as it should be," he said. – (HealthDayNews)

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Research Centre
Who paid for that study?

March 2007


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