FDA Reform: Call For Off-Record Talks

An off-the-record conference, attended by pharmaceutical industry chief executives and top-level officials of the US Food and Drug Administration to discuss the changes which the industry believes are needed at the agency, has been suggested.

The proposal has come from SmithKline Beecham's director of government relations, Burt Rosen, who believes that such a meeting would produce "some really frank discussions" to unearth the real problems, which could then begin to be addressed. Mr Rosen believes both sides are responsible for the adversarial attitude which has grown up between the agency and the industry, and this is the result of cultural or attitudinal differences. Cultural changes from the top down, in both the industry and the agency, are needed to resolve the problems, said Mr Rosen, according to a report in the Pink Sheet.

Allergan chairman Gavin Herbert also feels legislation may not be necessary to bring about improvements at the FDA, notes the report. He suggests that what may perhaps be needed is "some feet held to the fire by various congressional staffs to cause the agency to act in a more responsible way."