AAM Statement on FDA User Fee Reauthorization

WASHINGTON D.C. (February 2, 2022) – AAM strongly supports congressional reauthorization of GDUFA and BsUFA as negotiated and without changes. Timely approval of the FDA user fee agreements will ensure that patients continue to benefit from new, more affordable generic and biosimilar medicines. GDUFA III and BsUFA III are the culmination of months of negotiations, have been subject to public review and comment, and represent a careful balance between stakeholders.

User Fees Resources


Rachel Schwartz

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 18 percent of total drug spending.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.


Association for Accessible Medicines


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