WASHINGTON, D.C. (December 20, 2022) – The Association for Accessible Medicines Interim President, David Gaugh, today released the following statement regarding the Consolidated Appropriations Act of 2023.
"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. Notably, this bipartisan legislation addresses late-stage labeling changes by brand-name drug companies that could delay generic competition, ensures FDA makes timely therapeutic equivalence determinations for 505(b)(2) products, and provides HHS with new authorities to support the U.S. production of certain generics and active pharmaceutical ingredients.
"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 Sen. Bill Cassidy, Sen. Tina Smith, Sen. Mitt Romney, Sen. Maggie Hassan, Rep. Buddy Carter, Rep. Angie Craig, and Rep. John Curtis.
"Patients will benefit from their leadership and from access to lower-cost medicines at the pharmacy counter."
Director of Communications, 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 91 percent of prescriptions dispensed in the U.S. but only 18 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.