Sending Office: Honorable Andy Levin
Supportive organizations: Families USA, Patients for Affordable Drugs, Social Security Works, CSRxP
We urge you to cosponsor the bipartisan Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act, a commonsense bill to stop pharmaceutical companies from gaming the system to block generic competition.
There have been
numerous reports of drugmakers attempting to use the Food and Drug Administration’s (FDA) “citizen petition” tool to keep cheaper generic drugs from coming to market. While the citizen petition is meant to ensure stakeholders can flag legitimate issues
with drugs awaiting FDA approval, reports indicate that drugmakers have filed baseless petitions to protect their monopolies. In October, then-FDA Commissioner Scott Gottlieb listed the misuse of citizen petitions among
“anticompetitive techniques of concern.” Even if FDA doesn’t ultimately agree with the petition’s argument, the agency is forced to investigate and respond to what are sometimes unsubstantiated claims. These games prevent more affordable medicines from
reaching consumers quickly, forcing American families to pay more for pricier drugs.
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 will ensure pharmaceutical companies can’t misuse FDA’s citizen petition tool to keep prices high. Specifically, our bill outlines circumstances under which 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 it’s based on—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.
We hope you will join this bipartisan effort to bring down drug prices and protect consumers. If you would like to cosponsor this legislation, please contact Catherine Rowland (Levin) at
Catherine.Rowland@mail.house.gov or Kenneth Clifford (Rooney) at
Thank you for your consideration.
Member of Congress
Member of Congress
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