FDA's new conflict of interest policy for advisory committee members eliminates many qualified candidates based on their institutional affiliation, Cleveland Clinic cardiologist Steven Nissen, MD, said at FDC-Windhover's FDA/CMS Summit.

The agency finalized its conflict of interest guidelines in August as part of a broader revamping of the advisory committee process. (¹ Also see "Advisory Committee Policy Allows Members With Financial Conflicts To Vote" - Pink Sheet, 11 August, 2008., p. 11). The finalized CoI guidance, while less restrictive than the draft version, is still "arcane" and too limiting, Nissen said.

"The current rules are pretty bizarre," Nissen told attendees at the FDA/CMS Summit on Dec. 4. "The imputation of conflict of interest guidelines based on institutional contracts eliminates a lot of desirable people" - a list that Nissen says includes himself.

FDA's revised guidance capped the financial interests an advisory committee member can have at $50,000 in personal holdings; the earlier draft version included an institution's holdings in that figure as well. But the guidance also excludes members with the following conflicts:

An expert who is or will be a principle investigator of a product (or its competitors) that is the focus of an advisory committee meeting and his/her employer receives funding from the product sponsor; or,An expert who is the head of a department that is conducting or will conduct studies on a product (or its competitors) that is the focus of a meeting and receives personnel or salary support, designs or advises on any aspect of clinical trials, or reviews data or reports from the trials.

For Nissen, that second criterion could conceivably bar him from serving. Nissen was a permanent member of the Cardiovascular and Renal Advisory Committee from 2001 to 2005. Since then, he has served as a temporary member, most recently for a discussion on endpoints for type 2 diabetes (² [A#00700280003], p. 6).

Nissen chairs the Department of Cardiovascular Medicine at the Cleveland Clinic. With more than 100 faculty members, "for most advisory committees, it is highly likely that someone within our department is involved with the company in some fashion," he said.

"I can't get vetted for an advisory committee anymore," he said at the FDA/CMS Summit. "Nobody is more fiercely independent than I am. Nobody owns me. But the fact that my institution does lots of studies means that I can't be on an FDA advisory panel."

Nissen acknowledged that many drug sponsors would not fret too much over his inability to serve on an advisory committee. After all, his cardiovascular drug safety analyses prevented the approval of Bristol-Myers Squibb/Merck's Pargluva (muraglitazar), and crippled the commercial future for GlaxoSmithKline's Avandia (rosiglitazone).

But if he is disqualified under the conflict of interest guidelines, it does not bode well for the system as a whole. FDA is desperately trying to staff up its various advisory committees, without much success. Despite a major recruitment initiative, most panels have multiple vacancies ( ³ The RPM Report, October 2008 ).

"The last thing I am is a pawn of anybody. And yet, the rules are written in such a way that it is pretty hard for me to serve," Nissen said. "I don't know that that serves the public interest."

- Kate Rawson (k.rawson@elsevier.com)

FDA’s Advisory Committee Conflict of Interest Policy Too Restrictive, Nissen Says

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