WASHINGTON — The Association for Accessible Medicines has applauded the passage of Q1/Q2 legislation in the U.S. House of Representative. The measure passed as a part of the Give Kids a Chance Act. The legislation introduced by Representatives by Congressmen Dunn of Florida and Mullin of California and was marked up by the House Energy and Commerce Committee earlier this year. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and was reintroduced this Congress.
“AAM and the Biosimilars Council applauds House passage of the Q1/Q2 legislation,” said John Murphy III, President and CEO of the Association for Accessible Medicines. “Generic medicines bring lower prices for lifesaving and lifechanging medications when they become available. Q1/Q2 expedites the process for the industry and at FDA for generic medicines submissions, which will increase and speed up patient access to lower-cost medicine. Thank you to Congressman Dunn and Mullin and the Commerce Committee for their work on this important issue and we encourage the Senate to pass the bill soon.”
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 over one billion dollars and bring lower-cost medicines to patients sooner.
