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February 8, 2022

Energy and Commerce hearing on FDA user fee reauthorization

On February 3, the Subcommittee on Health of the Committee on Energy & Commerce held a hearing entitled, "FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics," where the committee heard testimony from Food and Drug Administration (FDA) officials as well as industry representatives on the user fee reauthorizations: Prescription Drug User Fee Amendments (PDUFA VI), Generic Drug User Fee Amendments (GDUFA II) and the Biosimilar User Fee Amendments of 2022 (BsUFA II). The current user fee agreements expire on September 30, 2022 and the final performance goal letters submitted to Congress, which were negotiated between industry and the FDA, will cover fiscal years 2023 through 2027. The performance goal letters contain the FDA's commitments on review timelines, hiring estimates, and program enhancements for each review program. The Medical Device User Fee Amendments were not discussed, as Congress awaits an agreement from the FDA and industry.

Throughout the hearing, the committee and witnesses stressed the importance of passing the user fee agreements and applauded enhancements contained within them to strengthen staff capacity at the FDA and enhance consistency and effectiveness of drug reviews. Members and panelists discussed the importance of expedited approval processes, including enhanced preapproval communications between the FDA and industry, as well as additional guidance and pilot programs aimed at enhancing development of drugs, such as those with unmet clinical need and for rare diseases, as well as programs aimed at enhancing patient access and facilitating earlier and more frequent communication between the FDA and industry. Members stressed the importance of expediting access to cell and gene therapies, rare disease drugs, and biosimilars, along with lower-cost complex generics and other innovations. They also noted the importance of ensuring diversity in clinical trials as well as the use of real-world evidence (RWE) and patient experience data throughout the drug review and development process. Several members also expressed their concern over the approval of Aduhelm as well as the expansive National Coverage Determination (NCD) from CMS. Other topics included advanced manufacturing, remote oversight, recall authority, and more.

Additional information is available in the attached Tax Alert.


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For additional information concerning this Alert, please contact:
Washington Council Ernst & Young
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Energy and Commerce hearing