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Sunday, July 1, 2007

FDA Officials Acknowledge Calendar Failings

The Post reports that FDA's top officials failed to properly report meetings with industry as required by regulation.  The FDA calls it an administrative oversight; others contend it is representative of a broader lack of openness.

The meetings that have since been disclosed are almost all related to negotiation of user fee regulations -- i.e., not the meetings about specific drugs, approvals, actions, and the like.  Public Citizen's Sidney Wolfe proposes that lower-level meetings should be required, since that's where much of the rubber-meets-road stuff happens:

Frequent FDA critic Dr. Sidney Wolfe called it "ridiculous" that the FDA had failed to post the calendar listings but suggested the requirement should be expanded to cover even lower-level employees at the agency. It's those employees, Wolfe said, who spend the most time meeting face-to-face with drug companies.

"Before decisions that seem to be going in the wrong direction from the public health perspective, it might be nice to know a company was in there," said Wolfe, of the watchdog group Public Citizen.

--BC

(I do a small amount of work for pharmaceutical companies.)

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