FDA’s user fee programs for prescription and generic drugs, medical devices, and biosimilars must be reauthorized by September 30, 2022. On June 8, 2022, the House passed its version of the Food and Drug Amendments of 2022, and on June 14, 2022, the Senate HELP Committee marked up the similarly situated Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA). Both bills increase the base fees for user fees; notably the medical device user fee reauthorization adds the potential for fee increases if FDA meets certain performance goals.
Congress typically utilizes the must-pass legislation as a vehicle to include additional FDA-related items. For instance, both bills include reforms to FDA’s Accelerated Approval Program – an increasingly scrutinized program which allows for the early approval of a new drug based on a predicted clinical benefit, as opposed to demonstrating an actual clinical benefit. Both House and Senate versions also require sponsors to begin post-approval trials before bringing the product to market and aim to streamline the process for FDA to remove products from the market that fail to ultimately show a benefit.
Both bills also contain generic drug competition riders, including a proposal to require the FDA to issue explanations on its determinations as to whether a generic drug product is the same as an existing product and letting FDA approve a generic drug even if a brand name drug’s labeling changes during the review process.
The House bill includes provisions to improve diversity in clinical trials and to address limitations in FDA’s facility inspection authority. The Senate version includes provisions aimed at increasing dietary supplement and cosmetic regulation.