U.S. Senate & House Markup FDA User Fee Reauthorization Legislation

May 20, 2017

On May 18, the House Energy & Commerce Health Subcommittee unanimously voted to advance legislation that would reauthorize the U.S. Food and Drug Administration’s (FDA) authority to collect user fees for another five years.

User fees paid to the agency are intended to supplement (not supplant) congressional appropriations, and provide the vast majority of the agency’s financial resources for conducting drug and device product reviews. This user fee reauthorization legislation advanced last week notably includes a provision to improve medical device facility inspections, based on H.R. 1736, legislation led by Reps. Larry Bucshon (R-IN), G.K. Butterfield (D-NC), Susan Brooks (R-IN), and Scott Peters (D-CA). CLSA has endorsed the bill and is strongly supportive of inclusion of this measure in the broader package.

Additional amendments adopted included:

  • Kurt Schrader (D-OR) & Gus Bilirakis (R-FL): Expedites generic drug applications
  • Michael Burgess (R-TX), Gene Green (D-TX), and Leonard Lance (R-NJ) Strengthens drug supply chain
  • Patrick Kennedy (D-MA) and Marsha Blackburn (R-TN) Creates an FDA category for over-the-counter hearing aids

The Senate Health, Education, Labor & Pension (HELP) Committee marked up their version of the bill on May 11, by a vote of 21-1, with Sens. Rand Paul (R-KY) and Bernie Sanders (I-VT) voting against the bill. Only two amendments received a voice vote, one from Sens. Susan Collins (R-ME) & Al Franken (D-MN) that would expedite the review of some generic drug applications. The other, authored by Sen. Orrin Hatch (R-UT), would expand clinical trial criteria to allow sicker patients to participate. It would also make it easier for patients to use an FDA program to receive unapproved drugs when they don’t qualify for trials. Another amendment by Sen. Sanders regarding importation was tabled by a vote of 13-10, and will most likely be voted on when the bill reaches the Senate floor.

During the week of May 24, we are anticipating that the House Energy & Commerce full committee to markup the amended FDA user fee agreements. Neither chamber has announced a date for floor action. However, both chambers must pass identical legislation, and the President must sign it into law, well ahead of the current program’s expiration on Sept. 30, 2017.

Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (