AAM Statement on Senate Passage of FDA User Fee Reauthorization (FDARA)

WASHINGTON, DC (August. 3, 2017) – The Association for Accessible Medicines (AAM) and it’s Biosimilars Council applauds the leadership of Senator Lamar Alexander (R-TN) Sen. Patty Murray (D-WA), Sen. Susan Collins (R-ME), Sen. Claire McCaskill (D-MO) and Sen. Al Franken (D-MN), and thanks the United States Senate for overwhelmingly passing the FDA Reauthorization Act of 2017 (FDARA) by a vote of 94-1.

“As the country grapples with the high price of health care, the strong bipartisan vote in the Senate recognizes the most effective and efficient way to contain prescription drug costs is to enhance competition by increasing the number of generic and biosimilar medicines available to patients,” stated Chester “Chip” Davis, Jr., President and CEO.

The GDUFA II and BsUFA II agreements will put in place the framework for using the best processes and science available to approve new safe, effective and affordable generic and biosimilar medicines. AAM and our members look forward to the President swiftly signing FDARA; working with the FDA to increase the number of applications reviewed and approved; and to ensuring a sustainable and competitive market for generics and biosimilars that will serve the best interests of patients moving forward.

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 on our about page.

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. Additional information is available at www.accesiblemeds.org.