Levin Bill to Lower Drug Prices Advances in Committee
The Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act, authored by Congressmen Andy Levin (D-MI) and Francis Rooney (R-FL), today passed the House Energy and Commerce Committee’s Subcommittee on Health.
“As we work to lower the cost of prescription drugs, we must close every loophole and safeguard against abuses that keep drug prices unsustainably high,” Congressman Levin said. “The STOP GAMES Act is an important, commonsense and bipartisan bill that we owe Americans who are paying too much for drugs they depend on.”
The STOP GAMES Act would prevent drug companies from misusing the Food and Drug Administration’s (FDA) “citizen petition” tool. When used appropriately, these petitions allow stakeholders to flag legitimate issues with drugs awaiting FDA approval. But there have been numerous reports of drugmakers attempting to abuse the petition to process to slow approvals and maintain monopolies on certain pharmaceuticals.
For example, in 2017, the Federal Trade Commission (FTC) filed a complaint contending that ViroPharma’s use of the citizen petition process constituted an antitrust violation. According to the FTC, ViroPharma’s “repetitive, serial, and meritless filings lacked any supporting clinical data” and “succeeded in delaying generic entry at a cost of hundreds of millions of dollars.”
The STOP GAMES Act outlines circumstances under which the FDA can promptly reject a petition meant to delay the approval of a generic competitor and directs the Secretary of Health and Human Services to report these incidents to the FTC.
The bill also requires drugmakers to file a petition within 60 days of learning the information on which it is based—not right before a patent or exclusivity period expires and rival drugs can come to market.
Finally, the bill requires enhanced reporting to keep Congress informed of efforts to game the FDA approval process.