Wednesday, October 22, 2008

FDA Advisory Committees: Who’s Running the Show?

You wouldn’t think of running your company without a CEO, right? Sure, from time to time, your company might find itself with an acting chief executive due to a merger or sudden departure. Maybe it’s a member of the board, or a former company official that comes out of retirement. But since that’s not a great situation for anyone, you try to quickly find a permanent replacement.

So it may make you a bit uncomfortable to know that at your next FDA advisory committee meeting, chances are that not only will the committee be lacking a permanent chair, it’s likely it won’t have had one for quite some time.

In fact, three quarters of advisory committees in the Center for Drug Evaluation & Research do not have a permanent chair. That’s 12 out of 16 committees. Only four—Anethestic & Life Support Drugs, Pharmaceutical Science, Psychopharmacologic Drugs and Reproductive Health Drugs—have permanent leadership.

(For an analysis of the advisory committee system—including a handy chart of vacancies in each committee—read this story in the October issue of The RPM Report.)

Chairs play a big role in the way advisory committee meeting is conducted. They can steer the discussion one way or another, tweak the questions from FDA, and be more or less forgiving in allowing the sponsor to clarify discussion points. Some chairs are better at managing meetings than others, and the absence of a clear leader can make the process less predictable for drug sponsors.

The absence of leadership at the top is really indicative of the systemic problems across FDA’s advisory committee system. Chairs are typically “promoted” from within, so when there aren’t enough committee members to go around, chairs—with the extra responsibilities that come with the job—are even harder to find.

And FDA is having a hard time finding committee members. Between the new conflict of interest rules and the existing downsides to serving on a committee, FDA has a major problem on its hands.

That might not be such a big deal, so long as FDA wasn't holding many advisory committee meetings. But that’s not the case. In fact, the agency will bring more new products before an advisory committee this year than it has since at least 2004. That’s a lot to juggle at a time when FDA is having a hard time filling those seats with permanent members.

Given the amount of time spent on preparing for an advisory committee review—including those mock panels—it would be nice to at least know who you’ll be facing across the conference table. And in case you’re still not convinced that FDA's problem with filling vacancies is also your problem, consider this: how would you like to have Sid Wolfe as a voting member at your next review?

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