FDA User Fee Agreements will help FDA uphold the highest standards of safety and effectiveness while reviewing and approving new drugs and devices
WASHINGTON, August 18 — President Trump today signed bipartisan legislation authored by Senate health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) to speed safe drugs and medical devices into patients’ medicine cabinets and doctors’ offices, while maintaining the highest standards of safety and effectiveness.
“The legislation signed by the president today will speed the FDA’s work to review new cures and treatments and get them into patients’ medicine cabinets and doctors’ offices,” Alexander said. “The first step was last year’s passage of 21st Century Cures to spur medical research, and this is the next step—legislation to help ensure that these breakthroughs in research make it to patients.”
“I’m pleased that Democrats and Republicans in Congress were able to set aside partisanship, work together to put patients and families first, and ensure the FDA continues to have the resources it needs to advance safe, effective medical products for people across the country,” Murray said. This legislation reflects years of hard work by the Obama Administration as well as members on both sides of the aisle, and I want to express my appreciation in particular to Chairman Alexander for his leadership. I hope we can build on this step forward with additional efforts to strengthen health care for the communities we all serve.”
The legislation was passed by the Senate on August 3 by a vote of 94-1.
The legislation includes four different user fee agreements that must be reauthorized by Sept. 30. The bill is virtually identical to legislation overwhelmingly approved by the Senate’s health committeeon May 11. This legislation will reauthorize the authority for the Food and Drug Administration (FDA) to accept user fees – paid by manufacturers of drugs and medical devices – that account for $8 to $9 billion over 5 years and is over a quarter of all FDA funding. The reauthorizations are based on recommendations from industry and FDA after a public process.
Over the last two years, the HELP Committee led by Alexander and Murray has held 15 bipartisan briefings, including some with the House Energy and Commerce Committee, to hear from FDA and industry about the reauthorization. The HELP Committee held two bipartisan hearings, on March 21 andApril 4, on the medical device and drug user fees. The committee held a markup on the bill on May 11, when two bipartisan amendments were adopted, and the committee overwhelmingly approved the bill—voting 21 to 2.