FDA Proposes More Transparency in Advisory Committee Conflicts of Interests

April 21, 2010

April 21, 2010 — Members of the 49 committees that advise the US Food and Drug Administration (FDA) on everything from antidepressants to computed tomography scanners to potato chips will have to disclose more about any conflicts of interest before they vote, according to proposed guidance released by the agency today.

From time to time, scientists on these committees who are not federal employees may have financial ties to companies whose products are on the agenda of a particular meeting. A scientist may consult for the company, for example, or work for an institution receiving research funds from it. The agency allows such members to vote at the committee meeting despite having such connections if the need for the member's expertise outweighs the potential for a conflict of interest. In this situation, the agency is said to grant a conflict-of-interest waiver. The FDA posts such waivers on its Web site.

The proposed agency guidance would give the public more information. Before each committee meeting, members currently complete a form — published online — revealing any financial connection to companies that could have a stake in an agenda item. To describe the nature of the potential conflict, the member need only refer to the categories of product "sponsor," "competitor," or "other affected firm." Under the guidance being proposed, members must reveal the name of the company or institution financially connected to them.

At a press conference today, Jill Hartzler Warner, acting associate commissioner for the FDA's Special Medical Programs, noted that the proposal to name names mirrors the kind of disclosure that academic journals require of authors.

Warner said that having advisory committee members with no conflicts of interest was ideal, and that the agency seeks out such individuals. "At the same time, we recognize that many of the top authorities in specific areas may have potential conflicts," she said. "To make the best decision for public health, the FDA at times must get advice from these experts."

The FDA will accept public comment on the proposed guidance for 60 days before it begins to draft a final version. Such agency guidance is not binding on the agency but merely reflects its current thinking on the subject.

Today's announcement is one more outgrowth of the agency's so-called transparency initiative, launched last year by FDA Commissioner Margaret Hamburg, MD, an appointee of President Barack Obama.

Roughly One-Third of Advisory Committee Positions Are Vacant

In a letter to FDA staff today about conflict-of-interest waivers, Dr. Hamburg addressed the "challenge of assembling top experts to advise the agency while maintaining the integrity of our decision-making process." She urged FDA staff to take 3 steps "to minimize the concerns" raised by the waiver process.

First, before recommending a waiver, consider the nature of the conflict of interest, writes Dr. Hamburg. "Not all conflicts are created equal." Some individuals have only a tangential financial relationship to a company affected by FDA regulations, such as an academic whose employer receives a company research grant even though he is not involved in the research himself. Second, Dr. Hamburg asked FDA staff to take into account the advice a committee would be offering. A waiver, she said, might be more appropriate for a committee member when the group is convening to consider a policy about a class of products, as opposed to approving one particular product. Third, FDA staff should justify each waiver recommendation by describing how they had searched for conflict-free experts and why the conflicted individual's participation in the committee is needed.

Dr. Hamburg's recommendations worry Sidney Wolfe, MD, director of the Health Research Group at Public Citizen, a consumer watchdog group. Dr. Wolfe told Medscape Medical News that the commissioner's letter to FDA staff suggests that the agency may be seeking to grant more conflict-of-interest waivers in the name of flexibility.

"When I saw it today, I said, 'Oh, oh, watch out,' " said Dr. Wolfe.

Technically, the FDA is free to increase the number of waivers. Dr. Hamburg noted in her letter that federal law caps the percentage of waivers at roughly 13% of all committee members participating in meetings during fiscal year 2010. "We currently are granting waivers for less than 5%," she writes.

To Dr. Wolfe, Dr. Hamburg's letter to FDA staff also may signal that the agency plans to accept more committee members whose financial connections to corporate healthcare would require waivers. That strategy would make recruiting easier, he said. "If you're on the FDA staff, it takes more time to find someone with no financial conflict of interest."

Of the 600-plus positions on FDA advisory committees, 218 are vacant, according to the agency's Web site.

At today's press conference, Jill Hartzler Warner said the FDA does not view Dr. Hamburg's guidelines as a "lessening of stringency." She added the agency "has challenges" filling committee vacancies, and that the number of open positions has been fairly high during the past few years. One of the agency's goals, she said, is to lower the vacancy rate to 10%.

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