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FDA Struggles to Keep Pace With Requests for Generics
Date:10/4/2007

More approvals are being recorded, but backlog continues to grow, officials say

THURSDAY, Oct. 4 (HealthDay News) -- Despite improved handling of generic drug applications and an increasing number of approvals, U.S. drug regulators face a rising tide of requests for approvals, officials said Thursday.

"This year, the FDA approved 682 generic drugs, an increase of 33 percent from last year," Dr. Andrew C. von Eschenbach, commissioner of the U.S. Food and Drug Administration, said during an afternoon teleconference. "We want to increase these numbers."

Last year, the FDA introduced a program it calls the Generic Initiative for Value and Efficiency, or GIVE, with the hope that it would modernize and streamline the agency's generic approval process.

Generic drugs are generally cheaper than the same brand-name drug, von Eschenbach said. Currently, generic drugs make up 63 percent of all prescription drugs sold in the United States but account for only 20 percent of dollars spent on prescription drugs, according to the Generic Pharmaceutical Association.

The FDA has a backlog of more than 1,300 drugs awaiting approval, Gary Buehler, the agency's director of the Office of Generic Drugs, said during the teleconference. "Over half these applications are protected by patents or exclusivities," he added.

Buehler noted that the number of applications continues to increase. "The average approval time for a generic drug is 16 to 17 months," he said.

"We have been increasing the number of approvals of generic products each year," Buehler said. "Yes, it has not kept up with the number of receipts we've gotten, but we have made impressive increases in the number of approvals, and we continue to put out a significant number of low-cost products to the American public."

As part of its streamlined approval process, the FDA is changing how it reviews certain drug applications. Generic produc
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