AAM Statement in Response to FDA's Competitive Generic Therapy (CGT) Designation

WASHINGTON DC (August 8, 2018) – "We applaud Commissioner Gottlieb and the FDA for recognizing the critical role generics play in helping to control overall drug costs. Generic manufacturers have responded to the Administration's efforts to increase competition through the new CGT pathway and remain committed to working to ensure that safe, effective and more affordable FDA-approved generics are accessible to patients and providers. This pathway, created through FDARA, is a better long-term sustainable solution than considering bringing in drugs from foreign markets."

Attribute to: Chip Davis, President and CEO

Rachel Schwartz 
202.249.7147 (o)
202.251.8881 (c)


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 23 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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