06.07.17

Alexander Praises House Energy and Commerce Committee Unanimous Passage of “Vital” FDA User Fee Agreements

Says the full Congress should complete work before the end of July on bipartisan legislation to deliver promising research to patients

WASHINGTON, June 7, 2017 – Senate health committee Chairman Lamar Alexander (R-Tenn) released the following statement after the House Energy and Commerce Committee passed – by a vote of 54-0 – bipartisan legislation reauthorizing the Food and Drug Administration (FDA) user fee agreements:

“If you have a family member with cancer, or Alzheimer’s, or diabetes, you want the FDA to move as quickly as it can to get safe drugs and devices through the regulatory process into patients’ medicine cabinets and doctors’ offices. These FDA user fees pay one out of every four dollars that make the agency’s work possible. With today’s successful, bipartisan vote in the House Energy and Commerce Committee and the Senate health committee’s overwhelming passage of our legislation last month, there is no reason for Congress not to reauthorize these agreements before the end of July.”

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. The legislation is now ready for consideration by the full Senate.

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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