Saves more than $800 million over 10 years; brings lower-cost medicines to patients sooner
WASHINGTON (April 4, 2025) — The Association for Accessible Medicines today commended reintroduction of Q1/Q2 legislation, S.1302 in the U.S. Senate. The bill was introduced by Senators Hassan of New Hampshire, Paul of Kentucky, Hickenlooper of Colorado, and Lee of Utah. This bill, which had bipartisan and bicameral support in the last Congress, was also reintroduced in the House last month by Congressmen Dunn of Florida and Mullin of California.
“AAM is grateful to Senators Hassan, Paul, Hickenlooper, and Lee for reintroducing Q1/Q2 legislation,” said John Murphy III, President and CEO of the Association for Accessible Medicines. “This legislation will increase patient access to lower-cost generic and biosimilar medicines by improving efficiencies at the FDA. Generics provide 90% of all dispensed medicines in the United States and provide significant savings for patients over brand name drugs. We look forward to continuing to work with the Senate and House sponsors to pass this legislation and find solutions that will enable Americans to live healthier lives, lower overall drug costs, and help patients have access to the generic and biosimilar medicines they need.”
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.
AAM Release on House Introduction
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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.
