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April 28, 2022

Senate HELP hearing on FDA user fee agreements | Advancing medical product regulation and innovation for the benefit of patients, FDA Center Directors

On April 26, the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing entitled, "FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors." The hearing was the second of two the committee has held on Food and Drug Administration (FDA) user fee agreements, which authorize the FDA to collect user fees from drug and device manufacturers and requires congressional reauthorization every five years.

During the hearing, committee members discussed a range of topics related to the Prescription Drug User Fee Amendments (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), Biosimilar User Fee Amendments (BsUFA III), and the Medical Device User Fee Amendments (MDUFA V), which would authorize new user fees for their respective industries for fiscal years 2023–2027. Witnesses at Tuesday's hearings included representatives from the FDA who answered questions on ways the latest agreements would improve FDA's ability to provide access to safe and effective drugs and medical devices, as well as related topics.

More information is available here.

Additional information is also available in the attached Tax Alert.


Contact Information
For additional information concerning this Alert, please contact:
Washington Council Ernst & Young
   • Heather Meade (
   • Heather Bell (


Senate HELP hearing on FDA user fee agreements