AAM Statement on House Energy and Commerce Health Subcommittee Markup of H.R. 7667 Reauthorizing Generic Drug and Biosimilar User Fee Amendments

The Association for Accessible Medicines (AAM) greatly appreciate the leadership of Chairman Pallone, Ranking Member McMorris Rodgers, Chairwoman Eshoo and Ranking Member Guthrie and applaud them for advancing the Food and Drug Amendments of 2022 Act (H.R. 7667), legislation to reauthorize the FDA’s user fee programs for an additional five years. The FDA 2022 Act will help ensure the timely review of generic and biosimilar applications and includes critical improvements to help facilitate the development of complex generic medicines.

America’s patients will benefit from greater access to lower-cost generic and biosimilar medicines and through significant savings at the pharmacy counter. We look forward to working with Congress to advance this bipartisan legislation into law in a timely manner and well ahead of September’s expiration of the generic drug (GDUFA) and biosimilars (BsUFA) user fee programs.

Attribution: Dan Leonard, President and CEO, AAM

Allen Goldberg

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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