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House Passes Bipartisan Bill to Reauthorize FDA’s Critically Important User Fee Programs

Jul 12, 2017
H.R. 2430 is a Win for Patients and the Millions of Americans Creating New Cures and Therapies

WASHINGTON, DC – The House of Representatives today passed H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, by voice vote.

H.R. 2430 reauthorizes FDA’s critical user fee programs, ensuring the agency has the tools they need to deliver safe and effective drugs, devices, and treatments, to patients more swiftly.

“This bipartisan work has produced a big win for patients,” said Energy and Commerce Committee Chairman Greg Walden (R-OR). “FDARA will help bring lower-cost generic drug alternatives and biosimilars to market faster – increasing competition and lowering drug costs – and it will streamline the process for reviewing and approving new treatments and cures for patients, ultimately delivering new and innovative therapies, drugs, and devices to patients more quickly.”

In April, bipartisan leaders of the Energy and Commerce Committee, along with bipartisan leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, reauthorizing FDA’s user fee agreements. The draft followed a series of hearings examining the four individual user fee programs – the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA). #SubHealth advanced H.R. 2430 by voice vote in May, and passed out of the full committee by a vote of 54-0 in June.

Need to catch up on FDARA? Check out this video of Energy and Commerce Committee members explaining why H.R. 2430 is a win for everyone.