FDA User Fees Reauthorization Discussion Draft Released

On Friday April 14th, leaders of the Senate HELP and House Energy and Commerce Committees released a clean discussion draft of bipartisan legislation that would reauthorize the Food and Drug Administration’s (FDA) four user fee agreements, including the medical device user fee amendments (MDUFA). The FDA Reauthorization Act of 2017 would allow the FDA to continue to collect user fees that support the safe and timely review of medical products. Under the new draft agreement, the FDA would see an increase of almost $400 million in user fees collected in the next fiscal year. The FDA user fee agreements are set to expire on September 30th, and need to be reauthorized before the August Congressional recess in order to avoid layoff notices being issued to over 5,000 FDA employees. For a complete section by section summary of the discussion draft click here.