The STOP GAMES Act would prevent drug companies from slowing approvals of generic drugs to maintain monopolies on certain pharmaceuticals.
WASHINGTON, D.C. – Today Congressman Andy Levin (MI-09), a member of the Health, Employment, Labor and Pensions Subcommittee of the House Education & Labor Committee, introduced legislation to lower drug prices by closing a loophole pharmaceutical companies have used to delay the approval of generic drugs. 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 of generic drugs and maintain monopolies on certain pharmaceuticals.
"It's time to rewrite the rules that have led to enormous profit for pharmaceutical companies and huge, unpayable bills for working families," said Rep. Levin. "One of the best ways to reduce drug prices is to bring generic drugs to market as quickly as possible, so consumers can get the medicines they need for a fraction of monopoly prices. The STOP GAMES Act will make sure that big pharmaceutical companies can't manipulate the FDA's rules to hold up the approval of cheaper drugs."
"The pharmaceutical industry has been exploiting our drug pricing system for far too long. The STOP GAMES Act takes on pharma's abusive tactic of rigging the FDA's citizen petition process — which is supposed to protect patients — to artificially extend brand companies' monopolies and prevent lower-priced generics from coming to market," said Sarah Kaminer Bourland, Legislative Director for Patients For Affordable Drugs Now. "This bill is a step in the right direction to bring relief to the patients paying too much for medications they need."
"People with MS rely on affordable access to medications to live their best lives", said Bari Talente, Executive Vice President, Advocacy and Healthcare Access, National MS Society. "Generic medications play an important role in the life cycle of medications — creating competition, lowering costs across the healthcare system and making medications more affordable for those who need them. The STOP GAMES Act is a common-sense approach to prevent further misuse of the FDA citizen petition process. This misuse has resulted in delaying generic competitors from coming to market and has kept prices artificially high."
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 bill also requires drugmakers to file a petition within 60 days of learning the information on which it is based—instead of holding the complaint until 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.
Source:https://andylevin.house.gov/media/press-releases/levin-reintroduces-bill-lower-drug-prices-and-increase-access-generic
