FDA is working on an initiative to fill up to two-thirds of the current vacancies on its advisory committees, but it is not backing down from a strict conflict-of-interest policy that many see as contributing to the advisory panel vacancies.

"One of our initiatives is to reduce vacancies to 10 percent," Jill Hartzler Warner, acting associate commissioner for special medical programs, said during an April 21 media conference call on the release of a new draft guidance on advisory committee member financial interest and waivers.

Ever since FDA adopted a stricter conflict-of-interest policy that discourages use of waivers to allow conflicted members to serve on panels, a major downstream impact has been the rising number of vacancies on its advisory committees (Also see "FDA Advisory Committees on the Brink: More Meetings, Fewer Members" - Pink Sheet, 1 October, 2008.). Reportedly, 218 positions of the 600-plus on FDA's 49 advisory committees have yet to be filled.

The general perception has been that the conflict-of-interest policy has made it more difficult to properly recruit for advisory committees. "There have been places where we felt we didn't have the right experts and we cancelled the meetings," John Jenkins, director of the Office of New Drugs, told attendees at the FDA/CMS Summit in December 2009 (Also see "Going Back to a New Approach: FDA, Outside Experts, and Conflicts of Interest" - Pink Sheet, 1 December, 2009.). "We may have gone too far."

Hartzler Warner seemed to downplay the role the conflict-of-interest rules are playing in the advisory committee membership shortage. "We have challenges in filling our vacancies, and that's certainly is an important consideration for us. But this number has actually been fairly high over a number of years," she said on the media call.

FDA is required to vet potential advisory committee members for conflicts of interest and those requirements were strengthened by the FDA Amendments Act of 2007 (Also see "FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden" - Pink Sheet, 24 September, 2007.). FDA's initial draft guidance on disclosure of conflicts of interest for advisory committee members came out in 2002. It was revised in light of the new FDAAA requirements in October 2007. The law requires that the agency disclose on its website "the type, nature and magnitude of any disqualifying financial interests" in cases where it is considering giving a prospective advisory committee member a waiver ('The Gray Sheet,' Oct. 30, 2007).

There were slight tweaks before the final guidance was issued in August 2008; FDA said it would allow advisory committee participants with personal financial conflicts of interest to fully participate in meetings, eliminating the draft provision that financial conflicts of any sort preclude an opportunity for panelists to vote (Also see "Advisory Committee Policy Allows Members With Financial Conflicts To Vote" - Pink Sheet, 11 August, 2008.).

New Disclosure Requirement

The guidance has now been revised yet again and was released April 21 in draft form, with a 60-day comment period ending June 20, 2010. The main difference in this latest version is that there is a requirement for public disclosure of the source of the financial conflict.

The appended form that FDA gives potential advisory committee members to use in listing their "imputed interests" now instructs them to identify the name of the company or institution. "This is a change from the August 2008 guidance, where the nature of the interest was identified only as sponsor, competitor, or other affected firm."

The intention of that change, FDA explained, is to increase the transparency of the agency's procedures.

Asked whether industry would object to this change, Hartzler Warner said the new policy "is very consistent with existing policy in other areas. For example, academic journals often require [such disclosures]."

The change would also be in line with policymakers' heightened interest in open identification of financial ties in the health care arena. The health care reform law, for example, contains provisions aimed to bring "sunshine" to this area, including one requiring annual reports by medical product manufacturers on payments to physicians and teaching hospitals ('The Pink Sheet,' March 29, 2010).

Waivers Are A Moving Target, But FDA Is Clearly Shy Of Cap

While FDA is still able to grant conflict-of-interest waivers, the agency has the target of cutting the number of waivers granted 25 percent by 2012. Currently, FDA has leeway to grant waivers for up to 13 percent of advisory committee members in fiscal 2010. But in practice, the agency is far below that benchmark. Fewer than 5 percent of advisory committee members actually have such waivers, Hartzler Warner reported.

That FDA is using fewer waivers than possible is consistent with the viewpoint expressed by Commissioner Margaret Hamburg in a letter sent to FDA staff on the policy - which is itself an indication of the high profile that the topic has within the agency. "In my view, it is clearly better for the agency in fulfilling its public health mission when advisors have no conflicts of interest," the April 21 missive states.

Hamburg outlined three principles for FDA staff to consider (all of which are "consistent with existing agency policy").

"First, I ask that you consider the nature of the conflict of interest before recommending a waiver. Not all conflicts are created equal. For example, an academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly," Hamburg wrote.

"Second, I ask that you consider the type of advice to be provided by the advisory committee. A waiver may be more appropriate for a meeting about a policy issue affecting a class of entities or products than for a meeting focusing on approval of a specific product."

"Third, I ask that you justify a waiver recommendation with a description of the search for equally expert advisors without conflicts and an explanation of why the individual's participation is needed to afford the advisory committee essential expertise."

Hamburg added that center directors should review all waivers for consistency with these principles.

-Martin Berman-Gorvine ( m.berman-gorvine@elsevier.com )

FDA Working To Fill Advisory Panel Vacancies While Tightening Conflict-Of-Interest Rules

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