Alexander Leads Bipartisan Support for Accelerated FDA Reviews



Alexander Leads Bipartisan Support for Accelerated FDA Reviews | Lamar Alexander, HELP Committee, FDA, U.S. Senate

On Aug. 2, the U.S. Senate passed bipartisan legislation led by health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) intended to speed approval of safe drugs and medical devices.

Alexander said: "The Senate has sent to the president's desk legislation that will speed cures and treatments into patients' medicine cabinets. The first step was last year's passage of 21st Century Cures to spur medical research, and this is the next step -- ensuring patients see the benefits of those research advancements."

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 year and a half, the HELP Committee that Alexander chairs 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.

The bill includes provisions from:

  • Sens. Isakson and Bennet to improve the medical device inspection process.
  • Sens. Hassan and Young to improve communication about abuse-deterrent opioid products.
  • Sens. Enzi and Franken to encourage medical device development for children, and make sure FDA has appropriate expertise to review devices for children.
  • Sens Roberts, Donnelly, and Burr to allow more appropriate classification of accessories used with medical devices.
  • Sens Collins, Franken, McCaskill, and Cotton to improve generic drug development and help lower prescription drug costs.
  • Sens. Hatch, Bennet, Burr, and Casey to improve access to clinical trials for all patients.
  • Sens. Bennet, Rubio, Van Hollen, and Gardner to increase the development of new drugs to treat pediatric cancers and other diseases.