FDA's new conflict-of-interest disclosure policy for advisory committee members was inaugurated at the Aug. 4 Peripheral & Central Nervous System Drugs Advisory Committee meeting.

"There is a new procedure. I think we're the inaugural run of it, for disclosures of conflicts of interests," Committee Acting Chair Karl Kieburtz (University of Rochester) said at the meeting held to discuss the efficacy and safety of Pozen's migraine drug MT 100 (naproxen/metoclopramide) (see ¹ Also see "Migraine Two-Hour Pain Response Efficacy Standard Suggested By Committee" - Pink Sheet, 8 August, 2005.).

FDA Ethics Program Integrity Advisor Mary Anne Killian made a special presentation at the advisory committee on FDA's policy on conflict of interest waivers. Conflicts of interests "may include investment, consulting, expert witness testimony, contracts, grants, CRADAs, teaching, writing, speaking, patents and royalties, and primary employment," she said.

Each member of the committee then stated whether he or she had received a conflict-of-interest waiver from the agency and described the nature of the conflict.

Three out of 12 voting members on the advisory committee did not receive waivers. Kieburtz, Michael Hughes (Harvard School of Public Health) and Sheila Weiss-Smith (University of Maryland School of Medicine) did not receive a conflict of interest waiver.

Non-voting committee industry representative Roger Porter (former Wyeth VP Clinical Research & Development) was exempt from making a conflict-of-interest disclosure.

Previously, the executive secretary for the advisory committee disclosed members' conflicts of interests without elaborating on the details of the conflict.

An amendment to the FY 2006 House agriculture appropriations bill would bar FDA from granting conflict of interest waivers for advisory committee members (² Also see "Conflict Of Interest Waivers Would Be Barred For FDA Cmtes. Under Bill" - Pink Sheet, 13 June, 2005. p.24).

At a July 26 hearing, Rep. Maurice Hinchey (D-N.Y.) told FDA Commissioner Lester Crawford that members with conflicts should be restricted from voting and sit on the committee in an advisory capacity only (³ [A#00670310003], p. 5).

Under the new policy, each member discloses the nature and economic value of the conflict in accordance with FDA's Feb. 1, 2002 ⁴ draft guidance on conflicts of interest. The guidance requires members to differentiate whether the conflict involves the sponsor or a competing company. The guidance does not require members to identify the competing firms (⁵ Also see "Advisory Cmte. Conflict-Of-Interest Waiver Details Should Be Public – Bristol" - Pink Sheet, 8 April, 2002., p. 37).

Committee member Carol Koski (University of Maryland) and acting consumer representative Lily Jung (Swedish Neuroscience Institute) received waivers for owning stock in a firm competing with Pozen that ranged in value from $5,001 to $25,000; Koski additionally has between $25,001 and $50,000 in stock in another competing firm.

Five committee members - Ralph Sacco (Columbia University), Larry Goldstein (Duke University Medical Center), Stanley Fahn (Neurological Institute), Kenneth Michael Welch (Chicago Medical School) and Dilip Jeste (University of California, San Diego) - have participated in advisory boards and steering committees for firms competing with Pozen, for which they received less than $10,001 per year.

Several committee members divulged compensation for consulting work. Goldstein received less than $10,001 per year in consulting fees from three firms; the fourth firm's compensation ranged between $10,001 and $50,000, he said. Mark Lenaerts (University of Oklahoma) received a waiver for his participation in three speaker's bureaus, with payments ranging from less than $10,000 to $50,000.

Mark Green (Columbia University Headache Center) disclosed that he had received a waiver for his employer's three contracts and grants. The commitments are with companies competing with Pozen, and are valued at under $100,000, between $100,001 and $300,000, and over $300,000, he said.

A July 14 New England Journal of Medicine editorial recommended publishing the names and background of proposed committee members in the Federal Register and on the agency's website to create more transparency (⁶ Also see "FDA Advisory Committees Need Better Conflict Of Interest Procedures – NEJM" - Pink Sheet, 18 July, 2005., p. 16).

New FDA Conflict Of Interest Policy Enacted At MT 100 Committee Meeting

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