FDA plans to speed up approval process for generic drugs

The FDA on Thursday announced a new programme to speed up and modernise the approval process for generic drugs. "To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process," stated Gary Buehler, director of the agency's office of generic drugs.

Under the Generic Initiative for Value and Efficiency, the agency expects to give priority to applications for generic products that are the first of their type and aren't subject to blocking patents or exclusivity protections. Previously, the regulator decided on drug applications in the order they were submitted. As part of the new initiative, the FDA also plans to increase its number of generic drug reviewers from a current level of 215, and anticipates providing more feedback to the industry about how generic drug applications should be designed.

The US regulator said it is facing a backlog of 1300 applications for generic drugs, and it currently takes about 16 or 17 months to review an application. Buehler explained that "these applications represent a vast scope of products -- and over half are still protected by patents. There is no way we could approve all of these applications." The agency indicated that it approved or tentatively approved 682 generic products in the fiscal year ended September 30, a 30-percent increase over the year-prior period.

Commenting on the news, Kathleen Jaeger, president of the Generic Pharmaceutical Association, remarked that there "are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market." Specifically, she called for the FDA to address "core fundamental issues" that are blocking generic drugs from the market, such as the use of citizens' petitions by branded drugmakers to delay regulatory action.

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