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October 2008, Vol. 3, No. 16

FDA Advisory Committees on the Brink: More Meetings, Fewer Members 

By Kate Rawson

 

These days, everyone is being asked to do more with less.

The Food & Drug Administration is no exception. Congress is asking FDA hold more advisory committee reviews for new product applications, while at the same time forcing the agency to apply a tougher screening process in determining the individuals that can serve on those panels.

The result is a system stretched to its limits. Many committee rosters are down to the bare bones, with FDA trying to fill in the gaps with temporary replacements.

For drug sponsors at the last stage before approval, the best-case scenario is bad: fewer familiar faces around the advisory committee table—and therefore more unpredictability during a make-or-break event for new products. The worst case scenario is even worse: months of delays before the agency can even find enough experts to convene a meeting.

Something has to give. Unfortunately for industry, it will be drug sponsors that will get squeezed. Resource constraints are already forcing those deadlines to slip. Not being able to staff an advisory committee is just one more reason for a missed deadline.

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