WASHINGTON – The Association for Accessible Medicines has issued a statement thanking the House Energy and Commerce Committee for advancing Q1/Q2 legislation, which was previously introduced by Republican representative Neal Dunn of Florida and Democrat Kevin Mullin of California. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and has been reintroduced in this Congress.
“AAM thanks Representatives Dunn and Mullin for reintroducing this legislation and the House E&C Committee for markup of the bill this week,” said John Murphy III, President and CEO of the Association for Accessible Medicines. “This bipartisan issue expedites process efficiencies for the industry and at FDA for generic medicines submissions, which 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 and the committee 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,” the AAM statement reads.
Passing this bill would save the U.S. healthcare system hundreds of millions and deliver lower-cost medicines to patients sooner, according to AAM.
