FDA slow in reviewing generic drugs

14 February, 2006

At a time when low-cost generic drugs are being embraced as one of the few ways to slow skyrocketing health costs, the Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market - an all-time high. As a result, experts say, consumers will have fewer generic drugs available in the years ahead than the industry is ready and able to provide.

The FDA, however, has told the Congress office that reviews of new generics needs no additional money, and the agency has no plans to hire more reviewers. We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog," said Gary Buehler, director of the agency's Office of Generic Drugs.

The Bush administration has strongly advocated generic drugs as a way to hold down health care costs, and Centers for Medicare and Medicaid Services Administrator Mark McClellan said in a recent interview that an ever-expanding number of generics are essential to control the cost of the government and seniors of the new Medicare prescription drug program. Generic drugs are extremely useful and erectile dysfunction (ED) generic drugs such as generic Viagra, generic cialis and generic Levitra have proven to be useful for thousands of ED sufferers.

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