April 7, 2022
Senate Health, Education, Labor & Pensions hearing on FDA user fee agreements | Advancing medical product regulation and innovation for the benefit of patients
On April 5, 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." The hearing was the first of two the committee will hold on Food and Drug Administration (FDA) user fee agreements, which authorize the FDA to collect user fees from companies 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 each industry, as well as the Pew Charitable Trusts who answered lawmakers' questions on ways the latest agreements would improve access to lower cost drugs and address longstanding concerns with FDA processes.
More information is available here.
Additional information is also available in the attached Tax Alert.
HELP Committee hearing on FDA user fee agreements