AAM Statement on FDA Record Generic Approvals | Association for Accessible Medicines

AAM Statement on FDA Record Generic Approvals

WASHINGTON DC (October 11, 2018) – We appreciate the efforts of the FDA, under the leadership of Commissioner Gottlieb, to lower overall drug prices by seeking to increase the number of generic drug applications on an annual basis. It is important however to recognize that in the current U.S. health care system more generic approvals does not automatically translate into more competition. Not all new generic approvals make their way to market – by some estimates less than half do – which means the full benefit of generic competition to help counter increasing brand drug prices is not being realized.

As HHS Secretary Azar recently noted, there are a combination of forces that keep generics off the market and out of the hands of patients. In order to deliver on the President’s Blueprint to Lower Drug Prices, policymakers and lawmakers would be well-served to focus their attention and efforts on correcting market and legal imbalances and abuses that are keeping FDA-approved generics off the market.

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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