Shaky science at FDA

WASHINGTON - The FDA does not have sufficient resources and is not currently organized to cope with the accelerating pace of technical innovation and scientific challenges it is likely to meet in the near future, senior agency officials, and academic experts agree. The agency has begun a wide-ranging review and reorganization of its scientific activities that is intended to ensure that it is able to cope with the variety of new technologies and scientific discoveries that its reviewers and regulators will face.

At the same time, the agency is being forced to cut back the scientific research capabilities of the Center for Biologics Evaluation and Research (CBER). The FDA is warning that it will be forced to reassign almost 100 CBER researchers to desk jobs over the next five years under terms of the Prescription Drug User Fee (PDUFA) reauthorization negotiated with industry...