Will cut red tape, bring lower-cost medicines to patients faster
WASHINGTON, DC (September 18, 2025) – The Association for Accessible Medicines today thanked the House Energy and Commerce Committee for marking up Q1/Q2 legislation previously introduced by Representatives by Congressmen Dunn of Florida and Mullin of California. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and was reintroduced this Congress.
“AAM thanks Representatives Dunn and Mullin for reintroducing this legislation and the House E&C Committee for markup of the bill this week,” said John Murphy III, President and CEO of the Association for Accessible Medicines. “This bipartisan issue expedites process efficiencies for the industry and at FDA for generic medicines submissions, which will enhance patient access to lower-cost medicine. When generic medicines become available, they immediately bring lower prices for lifesaving and lifechanging medications. AAM looks forward to continuing working with the bill sponsors and the committee to move this legislation forward.”
The legislation will authorize FDA to cut through the bureaucratic red tape and disclose to a generic manufacturer the ingredient or ingredients that cause a proposed generic drug formulation not to be quantitatively and qualitatively, or Q1/Q2, the same as the brand-name reference product formulation.
Passage of this bill will save the U.S. healthcare system hundreds of millions and bring lower-cost medicines to patients sooner.
AAM on Q1/Q2 House Introduction
2025 U.S. Generic & Biosimilar Medicines Savings Report
For media inquiries, contact media@accessiblemeds.org.
About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, 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. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers 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 12 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the 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, government affairs, legal affairs, and regulatory policy. More information is available biosimilarscouncil.org.
