The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act seeks to curb the abuse of the Food and Drug Administration’s (FDA) petition process while preserving the opportunity to submit legitimate claims raising public health concerns.
WASHINGTON – This week, Representative Hakeem Jeffries (NY-08), Chairman of the House Democratic Caucus, Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, Senator Chuck Grassley (R-IA), Chairman of the Senate Finance Committee, Representative Jerrold Nadler (NY-10), Chairman of the House Judiciary Committee, Representative Doug Collins (GA-09), Ranking Member of the House Judiciary Committee, Representative Jim Sensenbrenner (WI-05), Ranking Member of the House Judiciary Subcommittee on Antitrust, Commercial and Administrative Law and Representative Peter Welch (VT-01) introduced new bipartisan, bicameral legislation to curb the abuse of the FDA petition process and increase access to affordable prescription drugs. The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would reduce the incentives for branded pharmaceutical companies to interfere with the regulatory approval of generics and biosimilars that would compete with their own products, a tactic that delays patient access to more affordable medications. The bill would also give the Federal Trade Commission (FTC) enhanced authority to take action against those who file sham petitions.“No one should be forced to make the unthinkable choice between lifesaving prescription drugs and putting food on the table. The Stop STALLING Act aims to drive down the sky-high cost of medicine by expediting access to affordable generic drugs for everyday Americans,” said Jeffries. “Senators Klobuchar and Grassley, along with Representatives Sensenbrenner, Nadler, Collins and Welch should be commended for their leadership in this regard.”
Specifically, the Stop STALLING Act would:
Although interested parties may file petitions with the FDA in connection with its review of certain drugs, concerns have been raised that pharmaceutical companies file serial petitions or last-minute petitions in attempts to delay generic approval, while imposing significant and unnecessary review costs on the FDA.
- Create an FTC cause of action against sham petitions as unfair methods of competition,
- Create a rebuttable legal presumption of illegality for certain petitions referred from the FDA with a finding that they were submitted for the primary purpose of delaying the approval of a drug application, and
- Grant the FTC the authority to seek civil penalties for violations.
|U.S. Representative Hakeem Jeffries (NY-08) is the Chair of the House Democratic Caucus. He sits on the Judiciary and Budget Committees and proudly represents New York’s 8th Congressional District, including parts of Brooklyn and Queens in the House of Representatives.