Congressman Andy Levin Introduces Bill to Lower Drug Prices, Increase Access to Generics
Congressman Andy Levin (D-MI) and Congressman Francis Rooney (R-FL) have introduced a bill that would bring down drug prices by preventing pharmaceutical companies from gaming the FDA approval process to block generic competition.
“Drugmakers are trying to game the system to preserve their monopolies on certain drugs by misusing an important tool of the FDA. No more,” Congressman Andy Levin said. “We cannot tolerate exploitation in our drug approval process while seniors are choosing between paying their bills and buying expensive, critical medicines. 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.
Congressman Francis Rooney stated, “Passing the STOP GAMES Act is vital to American’s access to safe and affordable generic prescription medication. It is unconscionable that big Pharma is abusing a legitimate FDA citizen petition process to artificially and disingenuously maintain their monopolies on prescription drug availability – essentially putting profits over people.”
The Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (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 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.