The Association for Accessible Medicines interim president, David Gaugh, shared the following statement regarding the Consolidated Appropriations Act of 2023, which on Tuesday was released by House Appropriations Committee Chair Rosa DeLauro (D-Conn.-03) and Senate Appropriations Committee Chairman Patrick Leahy (D-Vt.), and which consists of all 12 fiscal year 2023 appropriations bills:
"The Consolidated Appropriations Act of 2023 includes critical improvements to help facilitate the development of generic and biosimilar medicines and takes steps to enhance the security of the U.S. pharmaceutical supply chain. Combined with the five-year reauthorizations of GDFUA and BsUFA in September, the Consolidated Appropriations Act will increase competition from generic and biosimilar medicines and enhance patient access to lower cost prescription drugs."
Gaugh noted that this bipartisan legislation addresses late-stage labeling changes by brand-name drug companies that could delay generic competition, ensures the Food and Drug Administration makes timely therapeutic equivalence determinations for 505(b)(2) product and provides Health and Human Services with new authorities to support the U.S. production of certain generics and active pharmaceutical ingredients.
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Pointing out that these provisions are the result of months of bipartisan work led by Chairwoman Patty Murray, Ranking Member Richard Burr, Chairman Frank Pallone, Ranking Member Cathy McMorris Rodgers, Chairwoman Anna Eshoo and Ranking Member Brett Guthrie, along with Sens. Bill Cassidy, Tina Smith, Mitt Romney, Maggie Hassan and Reps. Buddy Carter, Angie Craig and John Curtis, Gaugh said, “Patients will benefit from their leadership and from access to lower-cost medicines at the pharmacy counter."
The legislation is expected to be considered first in the Senate and then later in the week by the House.