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WASHINGTON—The Association for Accessible Medicines today praised Congressmen Neal Dunn (R-FL) and Markwayne Mullin (R-CA) for reintroducing the Q1/Q2 legislation in the U.S. House of Representatives. This bipartisan bill, which was previously part of the 2024 year-end spending package, aims to streamline regulatory processes and enhance patient access to lower-cost medications.
“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 the Association for Accessible Medicines. “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.”
The legislation would authorize the FDA to disclose to generic manufacturers which ingredient(s) in a proposed drug formulation prevent it from being deemed quantitatively and qualitatively (Q1/Q2) the same as its brand-name counterpart. This targeted reform would remove bureaucratic hurdles that delay generic drug approvals.
If enacted, the bill is projected to save the U.S. healthcare system nearly $800 million over the next decade while expanding access to affordable medications. AAM pledged to work closely with lawmakers to advance the bill and ensure its passage.
