House Passes FDA User Fee Reauthorization Bill

On Wednesday, July 12, the U.S. House of Representatives passed by voice vote the FDA Reauthorization Act of 2017 (H.R. 2430).The bill reauthorizes the FDA’s ability to collect user fees for the review of prescription drugs, medical devices, generic drugs, and biosimilar biological products through 2022. The current user fee agreements are set to expire September 30th, and if the Senate is unable to advance the measure prior to the August recess, the FDA will be forced to issue layoff notices to over 5,000 employees.

Following passage in the House, Sen. Lamar Alexander, Chairman of the Senate HELP Committee and lead sponsor of the Senate FDA reauthorization bill, released a statement “urging [his] colleagues to pass the user fees legislation as soon as possible.” Alexander further noted “the Senate and the House have been working together in a bipartisan way for the last 18 months on these user fee agreements – and they are integral to helping the patients that rely on medical innovation.”