FDA unveils user fee program for generic drugs

WASHINGTON - The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement released by the agency yesterday.

The user fee proposal is one of three that the agency is submitting to Congress for approval. The agreements would charge drug manufacturers application fees for reviewing traditional drugs, generic drugs, and a new class of generic biotech drugs.


The FDA has used industry fees to hire extra staff to review regular prescription drugs since 1992. One of the proposals unveiled yesterday extends that approach to generic drugs, which have long had slower review times.

Whereas most new drugs are reviewed in 10 months, the typical review time for a generic drug is 30 months. The FDA has a backlog of more than 2,000 generic drug applications awaiting review, according to the Generic Pharmaceutical Association.

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The FDA proposes collecting $299 million in fees annually to hire additional generic drug reviewers starting in fiscal year 2013. That figure would come from an estimated 750 generic drug applications per year as well as other fees, including the inspection of foreign drug manufacturing sites. In return for these fees, the FDA will aim to review 90 percent of generic drug applications within 10 months.

Another first-of-a-kind agreement would charge companies for the review of generic versions of biotech drugs, which are complex medicines that often contain proteins and living microorganisms.

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