The House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill aimed at ending the abuse of citizen petitions to stall generic approvals.
Cosponsored by Reps. Andy Levin (D-Mich.) and Francis Rooney (R-Fla.), the Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019 (H.R. 2387), lays out criteria that the FDA would use to reject frivolous petitions.
Some lawmakers raised concerns during the markup about criteria the agency would use in assessing petitions. Rep. Morgan Griffith (R-Va.) worried that the legislation’s yardstick for abusive citizen petitions is too broad and could lead the agency to overlook legitimate scientific and regulatory issues. The current standard for denying a citizen petition looks for a primary purpose of delay and a lack of scientific basis, the proposed legislation doesn’t require both criteria be met.
“If you make the only test to be that there’s a primary purpose for delay, you’re ignoring if that particular citizen petition has a valid scientific purpose behind it,” he said.