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Article excerpt

Last year, the Food & Drug Administration gave its blessing to 53 new molecular entities and dozens of new indications for existing prescription products. Among the new releases were some major advances for your patients in the treatment of AIDS, cancer, asthma, diabetes, infections, schizophrenia, and heart disease.

This record crop of approvals was nourished by an accelerated system for reviewing New Drug Applications that saw the mean approval times for new drugs fall from 29.9 months in 1992 to 15.5 months in 1996, according to Pharmaceutical Research & Manufacturers of America (PhRMA).

What has helped to quicken the NDA approval pace is $327 million in user fees that the brand drug industry agreed to pay between 1993 and 1997. Those fees have enabled the FDA to hire 600 or so additional reviewers to process New Drug Applications. In fact, this user fee program has proven so successful that the generic industry is considering establishing its own user fee system with, of course, its own targeted performance guarantees.

Now, riding the popular success of the 1992 Prescription Drug User Fee Act, some key members of Congress are trying to lump its renewal, which comes up this September, with a package of FDA reform or improvement initiatives. So, what's wrong with that?

Perhaps, nothinq. But some drug manufacturers are concerned that the adoption of a new five-year user fee program might get mired in a bitter battle over some aspects of FDA reform, including the dissemination of information on the off-label use of drugs. Given the pace of politics, this is a real concern. …


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