WASHINGTON — The Association for Accessible Medicines has 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 Blog Q1/Q2 “Shenanigans”: https://accessiblemeds.org/resources/blog/end-brand-name-drug-delay-generic-competition
AAM Release on House Introduction: https://accessiblemeds.org/resources/press-releases/aam-commends-q1-q2-house-bill-reintroduction/
Legislation: https://www.congress.gov/bill/119th-congress/senate-bill/1302/cosponsors?s=3&r=12&q=%7B%22search%22%3A%22hassan%22%7D
AAM 2025 Advocacy Priorities: https://accessiblemeds.org/wp-content/uploads/2025/02/AAM-Protect-and-Defend-Patient-Access-Generics-Biosimilars.pdf
2024 U.S. Generic & Biosimilar Medicines Savings Report: https://accessiblemeds.org/resources/blog/2024-savings-report
