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

ting a "user fee" program, much like the one in place for pharmaceutical companies developing brand-name drugs. Under that program, companies pay the FDA a fee to help offset the cost of approving new drugs.

On Wednesday, the FDA said it was considering more "behind-the-counter" sales to let patients buy certain medicines directly from pharmacists without a doctor's prescription, the Associated Press reported.

The FDA said it was seeking public reaction to such a proposal, which might also ease access to medications for the uninsured.

"This is an issue that has been raised by pharmacists, by manufacturers, by patients," said Ilisa Bernstein, the agency's director of pharmacy affairs.

Currently, most drugs either require a prescription or are sold in a traditional over-the-counter method with no prescription needed. "Behind-the-counter" sales offer a third option, the AP reported.

Last year, the FDA allowed the emergency contraceptive known as Plan B, also called the "morning-after" pill, to be sold without a doctor's note to women 18 and older -- but only by pharmacies that checked women's photo identification. Minors still need a prescription for the drug, the news service said.

More information

To learn more about generic drugs, visit the FDA.



SOURCES: Oct. 4, 2007, teleconference with Andrew C. von Eschenbach, M.D., commissioner, U.S. Food and Drug Administration, and Gary Buehler, R.Ph., director, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville Md.; Oct. 4, 2007, news release, Generic Pharmaceutical Association, Arlington, Va.


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