AAM Statement on FDA Withdrawal of Generic Drug Labeling Rule

WASHINGTON DC (December 13, 2018) – “AAM applauds FDA Commissioner Scott Gottlieb and the agency for prioritizing consumer access to safe, high-quality, affordable generic medicines by withdrawing its proposed labeling rule. The agency correctly recognized the need for consistency and the potential for adverse consequences. The FDA’s action further exemplifies its focus on the best interest of the public’s health and provides patients with the utmost confidence in their health care choices.”

Attribute to: David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, 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 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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