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Harkin, Enzi Welcome Fee Agreements to Speed FDA Review of Medicines

WASHINGTON – Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), released the following statement welcoming today’s announcement that the Food and Drug Administration (FDA) has reached agreement with the prescription drug, generic drug, and biosimilar industries on the user fees that help speed the FDA’s review of medicines in order to make them available to Americans. 

“These user fee agreements are crucial to ensuring that medications become available to the American public quickly and safely. We applaud the FDA and the industries for the dedication and hard work it took to finalize these agreements.

“Moving forward, we expect the FDA and the medical device industry to continue to work together to resolve any outstanding issues quickly so our Committee can move forward with the work to authorize all four user fee agreements in a timely manner.  An agreement between FDA and the industry is critical to fostering greater innovation while ensuring that the review process for new medical devices is predictable, consistent, and transparent.”

Over the past several months, the HELP Committee has convened a series of bipartisan hearings to explore issues related to the user fee legislation.