Reauthorization of the FDA user fee agreement (UFA) package – that sets terms, conditions and costs for review of prescription drug (PDUFA), medical device (MDUFA), generic drug (GDUFA), and biosimilar (BsUFA) applications – is inching forward in Congress. In addition to codifying the agreements, these bills are often vehicles for other FDA policy changes.
On June 8, the full House passed the Food and Drug Amendments of 2022. In addition to the negotiated UFA agreements, the legislation includes provisions to increase clinical trial diversity,emphasizes the FDA’s role in assuring transparency and review of drugs and devices approved through an accelerated process and extends provisions supporting orphan drugs and treatments for rare diseases.
On June 14, the Senate Health, Education, Labor, and Pensions Committee passed their companion legislation, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA). It is similar to the House bill with a few significant differences. It does not include the diversity in clinical trials provisions but does increase FDA’s role in oversight over laboratory developed tests, and it requires the FDA to develop regulations that would facilitate the prescription drug importation from Canada.
The entire Senate still needs to approve their bill and then the two versions will have to be negotiated into a version that can pass both the House and Senate. Time is of the essence as the current agreements expire October 1 – this means that approval is necessary by late July to forestall FDA impacts on personnel and operations.