Breaking news about the long-awaited prescription drug user fee authorization, better known as PDUFA, which is set to expire on September 30th.
On Monday night, the House and Senate Appropriations Committee released language for a short-term continuing resolution (CR) that includes a five-year reauthorization of the FDA user fees and two-and-a-half-months of funding for the federal government.
The CR enables FDA to continue the life-saving momentum of its work, including the enhancements laid out in the FDA Commitment letter, which includes many rare disease-focused Performance Goals.
The FDA user fee reauthorization is a clean reauthorization. This means that it provides five years of authorization for the FDA user fee program but does not include any new policy provisions included in either the House-passed bill, or HELP-passed bill.
The CR does include two-and-a-half-month reauthorizations for eight FDA programs often included in user fee packages, including the orphan drugs grants program and the humanitarian use device program.
The CR funds the government through December 16th, ensuring that federal agencies will not run out of funding on October 1st. This provides an additional window of opportunity for advocates to ensure that appropriation provisions they are advocating for are included in the final omnibus bill expected this December. In addition, the omnibus negotiations also provide another opportunity for rare disease advocates to seek the inclusion of the many important policy provisions that were originally included in the user fee negotiations such as elements of the STAT Act, clinical trial diversity, and enhancements to the Accelerated Approval pathway.
