Harkin, Enzi Announce FDA User Fee Committee Print

WASHINGTON – Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), Chairman and Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today announced the release of the Food and Drug Administration Safety and Innovation Act Committee Print that will be considered at next Wednesday’s Committee markup. 

“This document represents a strong, bipartisan step towards the authorization of critically important legislation to ensure that the FDA can approve drugs, medical devices, generic drugs and biosimilars.  Failure to reauthorize the current user fee programs in a timely way threatens biomedical industry jobs, patient access to new therapies, and America’s global leadership in biomedical innovation. 

“We are continuing to work with our colleagues on the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and the Pediatric Medical Device Safety and Improvement Act.  These are vital pediatrics laws that have improved the safety and efficacy of drugs for millions of children and have stimulated the development of pediatric medical devices, and we are committed to their reauthorization.”

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