ASSOCIATION FOR ACCESSIBLE MEDICINES STATEMENT ON SENATE PASSAGE OF FDA USER FEE REAUTHORIZATION (FDARA)

WASHINGTON, DC – AUGUST 3, 2017 – The Association for Accessible Medicines (AAM)
today 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.