Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

Andrew Powaleny
Andrew Powaleny September 12, 2022

Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines.

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As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.

Thanks in part to PDUFA and BsUFA, the United States leads the world in the introduction of novel medicines and the FDA’s human drug review program is the global gold standard for regulatory review and approval. In 2021, 76% of novel drugs were first approved in the United States before any other country. The biosimilars marketplace is also continuing to grow and become more robust — today, 22 biosimilars are on the market in the United States, competing against nine brand biologics.

As Congress comes back to Washington for the September work period, it is vital policymakers ensure there is no delay in reauthorizing these user fee programs which expire on September 30, 2022. Failure to reauthorize the programs on time would disrupt the agency’s regulatory predictability to review critical medicines, including potential therapies for COVID-19.

For the United States to maintain its leadership in biopharmaceutical research and development and regulatory review, reauthorization of PDUFA and BsUFA is critical. New discoveries in drug development, including platforms for vaccines and cell and gene therapies, deliver the promise of treating debilitating diseases such as cancer, diabetes and many rare disorders. Fulfilling this promise depends on a modern regulatory framework, supported by PDUFA and BsUFA, that helps ensure patients have timely access to lifesaving medicines. As Congress makes efforts to move these reauthorization packages forward, it is important there is no delay in supporting the FDA's critical work.

PhRMA urges policymakers to act soon to pass these vital agreements. Patients are counting on them.

Learn more about PDUFA at PhRMA.org/PDUFA and BsUFA at PhRMA.org/Biosimilars

Topics: PDUFA, Biologics and Biosimilars