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Senate Follows House, Passes Bipartisan Bill to Reauthorize FDA’s User Fee Programs

Aug 3, 2017
H.R. 2430 is a Win for Patients and the Millions of Americans Creating New Cures and Therapies

WASHINGTON, DC – The Senate today passed H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, by a vote of 94-1, following the House’s passage of the bill last month.

H.R. 2430 reauthorizes the Food and Drug Administration’s (FDA) critical medical product user fee programs, ensuring the agency has the tools it needs to more efficiently deliver safe and effective drugs and devices to patients.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” said Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and Health Subcommittee Ranking Member Gene Green (D-TX). “This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

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 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. FDARA passed the House by voice vote on July 12, 2017.

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