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The picture might look quite different if FDA's new draft guidance for determining conflict of interest and eligibility for participation on its advisory committees were in force.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

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