ACS CAN Comments on Draft HELP Committee Draft of User Fee Reauthorization

The user fee program has provided critical resources for FDA to review drug and device applications, as well as to develop regulatory science and policy. ACS CAN is wholly supportive of reauthorizing the user fee programs, but have provided feedback related to Subtitle C, the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022, which creates a new oversight framework for in vitro clinical tests. In addition, as the process for reauthorizing the user fee programs continues, we urge Congress to take bold steps to improve the diversity of enrollment in clinical trials as part of this year’s Prescription Drug User Fee Act (PDUFA) reauthorization.