FDA's draft guidance on the procedure for disclosing conflicts of interest will extend the agency's disclosure policy to cover all advisory committee members.

The new policy will require all special government employees and regular government employees to make a disclosure statement about the type, nature and magnitude of any financial conflicts and obtain a waiver in order to participate in advisory committee meetings.

"FDA is revising this draft guidance to broaden its applicability, to bring as much transparency as possible to FDA's waiver process, and to increase the consistency and clarity of the process," the agency states.

A 2002 draft guidance on the disclosure of conflicts of interest was limited in scope to special government employees participating in meetings at which particular matters relating to particular products are discussed (¹ 'The Pink Sheet' Feb. 4, 2002, In Brief).

In addition to publicly disclosing financial conflicts of interest, regular government employees, such as those from the Centers for Disease Control and Prevention, report "financial interests on a yearly basis and/or just prior to the advisory committee they are planning to attend," the guidance states.

Beyond reading the reports provided by potential meeting participants, FDA "screens advisory committee members broadly for relationships that could present even the appearance that they have conflicts of interest that could affect their impartiality," the agency says.

"FDA reviews not only the financial interests of a potential advisory committee participant and his immediate family members, but also those of the participant's business partners [and] organizations for which" he does or will serve.

After disclosing all conflicts, the potential committee member must receive clearance from FDA to participate. The agency recently issued draft guidance that limits allowable financial conflicts to $50,000, which could preclude a significant portion of current committee members from future service (² [A#00690130008], p. 16).

The agency will also be forced to be more selective in its provision of conflict of interest waivers in the future due to a requirement of the FDA Amendments Act that calls for a 25 percent reduction of the total number of waivers granted by 2012 (³ Also see "FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden" - Pink Sheet, 24 September, 2007., p. 3). On average, drug-related advisory committees have more than two conflicted participants per meeting (⁴ Also see "Advisory Cmte. Conflict of Interest Waivers Common; Avandia Is High Water Mark" - Pink Sheet, 30 July, 2007., p. 9).

"As far as I can tell, this is largely going to affect the FDA and the way they recruit their advisory committee members, and probably not going to have a huge impact on industry per se," former Wyeth exec Bruce Burlington said during a recent Food and Drug Law Institute audioconference, "although how it plays out in terms of the industry reps on advisory committees is yet to be determined. ... They may not be able to be as active as in the past."

The draft guidance, "Public Availability of Advisory Committee Members' Financial Interest Information and Waivers," provides templates for both the financial conflict disclosure form and the FDA waiver form.

"For waivers that are granted, the disclosure statement signed by the advisory committee member will be posted on FDA's Web site, along with the agency's waiver," the draft states.

The documents will be posted at least 15 days before the relevant meeting, if possible at www.fda.gov/ohrms/dockets/acmenu.htm. "For disqualifying financial interests that FDA becomes aware of less than 30 days prior to the meeting and for which a waiver is issued, FDA will post the documents as soon as practicable and no later than the day of the meeting."

"These time frames are consistent with the requirements of" FDAAA, the agency notes. In addition, "the agency also plans to make the disclosure statements and waiver documents public at the corresponding advisory committee meetings."

- Brian Marson (b.marson@elsevier.com)

FDA Expands Advisory Cmte. Disclosures As Congress Directs Conflict Reductions

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