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.)