President Signs FDA User Fee Legislation



President Signs FDA User Fee Legislation | Lamar Alexander, Patty Murray, HELP Committee, U.S. Senate, FDA, Food & Drug Administration

Sen. Lamar Alexander

On Aug. 18, President Donald Trump signed bipartisan legislation authored by Senate health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) intended to speed safe drugs and medical devices into patients' medicine cabinets and doctors' offices, while maintaining safety and effectiveness standards.

"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 after the legislation was signed. "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 healthcare for the communities we all serve."

The legislation was passed by the Senate on Aug. 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 committee on 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 and April 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.