FDA has backlog on generic approvals

WASHINGTON, Feb. 4 (UPI) -- The Food and Drug Administration has a backlog of 800 generic drugs awaiting approval, the Washington Post reported.

Approvals are now taking about 20 1/2 months, up from just under 20 months in 1999, and 450 drugs were approved last year, 23 fewer than the previous year.

Gary Buehler, director of the Office of Generic Drugs, said he expects the backlog to get even bigger because there are likely to be a record number of applications for approval this year. He said there were 129 applications in December, a monthly record.

Officials from President George W. Bush on down are advocating generic drugs as a means of cutting high prescription drug costs, especially under the new Medicare prescription drug program.

Rep. Henry Waxman, D-Calif., who wrote the 20-year-old law to make generics more accessible, called the backlog "totally unacceptable."

"This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind," he said.