User Fee Agreements
User Fee programs help the Food and Drug Administration (FDA) to ensure timely review and support the development of innovative therapeutics. The FDA Reauthorization Act of 2017 reauthorized the pharmaceutical, medical device, generic drug, and biosimilar user fee agreements until 2022. The Alliance played an important role in the input process for the legislation, including enhancing regulatory science and expediting drug development, hiring of FDA staff, and patient-focused drug development (PFDD).
The Alliance continues to serve as a valued voice for patients in the user fee process and is currently engaged with the FDA in stakeholder discussions for the next round of user fee agreements to begin in 2022.