AAM Opposes Latest Prescription Drug Reform Framework

Proposed Medicare Negotiations, Inflation-Based Rebates Would Upend Patient Access to Generics and Biosimilars

WASHINGTON, DC (November 2, 2021) — In response to press reports on the current framework on prescription drug policies, AAM and its Biosimilars Council issued the following statement on the potential impact to patient access to generic and biosimilar medicines:

Patient access to more affordable generic and biosimilar medicines would be threatened under the policies currently under consideration in Congress. Competition from lower-cost generics and biosimilars has successfully led to decades of savings for patients. Continued access and savings to more affordable medicines would be jeopardized should these policies advance.

AAM strongly opposes an approach to direct negotiations in Medicare that would undermine biosimilar and generic development. Combined with inflation-based rebates on generics and biosimilars, the reforms being considered would upend the competitive framework envisioned with Hatch-Waxman and BPCIA and threaten sustainable patient access to more affordable medicine.

We strongly encourage Congress to advance policies that enhance generic and biosimilar competition and lead to meaningful savings at the pharmacy counter for patients.

Attribution: Dan Leonard, President and CEO, AAM

Rachel Schwartz


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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 20 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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