Alexander: Time for the Senate to Vote on Bipartisan FDA User Fee Agreements

WASHINGTON, July 12, 2017 – Senate health committee Chairman Lamar Alexander (R-Tenn.) today said it’s now time for the full Senate to consider bipartisan FDA user agreements legislation after the House of Representatives unanimously passed its user fee legislation.

“The Senate and the House have been working together in a bipartisan way for the last 18 months on these user fee agreements – and they are integral to helping the patients that rely on medical innovation,” said Alexander. “I’m urging my colleagues to pass the user fees legislation as soon as possible.”

In April, Senate and House health committee leaders released a discussion draft of bipartisan legislation reauthorizing four different FDA user fee agreements. The legislation renews FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars. The legislation also included significant new provisions to:

• Involve patients in the drug and medical device development process to make sure innovative new drugs and devices address what patients think are most important;
• Dedicate staff to assist in the development and review of rare disease drugs;
• Improve timelines and increase guidance for drug and device combination products, such as heart stents with drugs; and
• Modernize the clinical trial process so we can start to shorten the 8–10 years it takes to develop new drugs and get them to medicine cabinets.

On May 11, the Senate health committee overwhelmingly approved—by a vote of 21 to 2—its version of the legislation reauthorizing the FDA user fee agreements. The legislation approved by the committee contained over 20 provisions that were priorities for Senate health committee members.

Over the last 18 months, the Senate health committee has held 15 bipartisan briefings, including some with the House Energy and Commerce Committee, to hear from FDA and industry about the reauthorization. The Senate health committee held two bipartisan hearings, on March 21 and April 4, on all four medical product user fees.

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