WASHINGTON (AP) — 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 with industry released by the agency.
The FDA has used industry fees to hire extra staff to review regular prescription drugs since 1992. The proposal unveiled Friday would extend 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 2,500 generic drug applications awaiting review.
The FDA proposes collecting $299 million in fees annually to hire additional generic drug reviewers. The proposal must be approved by Congress to become law.