Reps. Dunn and Mullin bill will cut red tape, bring lower-cost medicines to patients faster, and save more than $800 million over ten years
WASHINGTON (March 7, 2025) — The Association for Accessible Medicines today applauded the reintroduction of Q1/Q2 legislation in the U.S. House of Representatives by Congressmen Dunn of Florida and Mullin of California. The legislation reintroduces bipartisan and bicameral language that was included in the 2024 year-end spending bill that was initially introduced.
“AAM thanks Representatives Dunn and Mullin for leading the charge to reengage this issue which enjoyed bipartisan support in 2024,” said John Murphy III, President and CEO of the Association for Accessible Medicines. “This bill expedites generic submission by creating process efficiencies for FDA and Industry. These efficiencies 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 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 would save the U.S. healthcare system more than $800 million over 10 years and bring lower-cost medicines to patients sooner.
Read AAM Blog Q1/Q2 “Shenanigans”
View AAM 2025 Advocacy Priorities
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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 13.1 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 at biosimilarscouncil.org.
