Monday, April 28, 1997
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
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.