AAM commends Q1/Q2 House Bill reintroduction

The Association for Accessible Medicines on March 7 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.

“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 AAM. “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.”

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

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 nearly $800 million over 10 years and bring lower-cost medicines to patients sooner, AAM said.

[Read more: AAM: Generic medicines increase patient access more than government negotiated price controls]