12:00 AM
Mar 26, 2007
 |  BioCentury  |  Politics, Policy & Law

The price of pristine

When FDA's Cellular, Tissue and Gene Therapies Advisory Committee meets this week to discuss whether the agency should approve the first cancer vaccine, a product that could establish proof of principle for an important new therapeutic class, several of the votes will be cast by internationally respected experts who were invited to join the committee on an ad hoc basis because of their specific expertise.

The picture might look quite different if FDA's new draft guidance for determining conflict of interest and eligibility for participation on its advisory committees were in force. Under the proposed policies, three of the invited experts probably would be ineligible to vote on Provenge sipuleucel-T from Dendreon Corp. (DNDN, Seattle, Wash.). And two might be completely barred from participating in the discussions.

The new, more stringent criteria for participating in advisory committee meetings will limit or preclude the participation of "a significant fraction" of serving committee members, Associate Commissioner for Policy and Planning Randall Lutter told reporters last week.

The policies are needed "so that the public has confidence in the integrity of the recommendations" made by the committees, Lutter said. They are intended to strike a balance between "having the best possible access to scientific experts who may by the nature of their work have had ties to private industry that is driving biomedical innovation in this country, and at the same time seeking to ensure we have the fullest public confidence in our advisory committee process."

FDA critics praised the announcement as vindication of their claims that the advisory process has been corrupted, while some former senior agency officials warned it will harm public health by preventing or deterring highly qualified scientists from participating on committees.

New filters

The draft guidance replaces previous policies, which did not spell out criteria for granting waivers from government COI regulations, with an algorithm for determining eligibility to participate (see "Conflict-of-Interest Algorithm," A18).

Generally, the decision tree would exclude individuals who have financial interests of $50,000 or more that might be directly affected by a meeting's outcome - or have had such interests in the previous 12 months.

In addition...

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