Summary
The Drug Competition Enhancement Act would make it illegal for pharmaceutical manufacturers to engage in 'product hopping'—a practice where a drug maker switches consumers to a modified version of a drug covered by a newer patent right when the original drug's patent is about to expire. This tactic can prevent cheaper generic versions from entering the market. Under this bill, the Federal Trade Commission would have authority to investigate and enforce against product hopping, treating it as an unfair business practice.
If a manufacturer is caught product hopping, the FTC could take legal action to stop the practice and require the company to pay back profits or provide restitution to consumers harmed by the anticompetitive conduct. Drug manufacturers could defend themselves by showing their actions were not intended to limit competition. The practical effect would be to help generic drugs reach patients faster and more affordably by closing a loophole that currently allows brand-name manufacturers to extend their market monopolies beyond their patent protections.
AI-generated summary
Lifecycle of the Bill
Committee on the Judiciary. Ordered to be reported with an amendment favorably.
Apr 3, 2025
HearingSenateMeeting
Apr 3, 2025 · 14:15
Business meeting to consider S.527, to require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, S.1040, to amend the Federal Trade Commission Act to prohibit product hopping, S.1041, to amend title 35, United States Code, to address the infringement of patents that claim biological products, S.1097, to amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, S.1095, to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and S.1096, to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products, and the nomination of Patrick David Davis, of Maryland, to be an Assistant Attorney General, Department of Justice.
Summary
On April 3, 2025, the Senate Judiciary Committee held a business meeting in Hart Senate Office Building to consider six bills aimed at increasing competition in the pharmaceutical market and reducing drug costs. The bills included S.1096, the Preserve Access to Affordable Generics and Biosimilars Act, which would prohibit brand-name drug companies from compensating generic drug manufacturers to delay market entry of generic drugs and biosimilar products. The committee also considered S.1040, addressing product hopping; S.1041, addressing patent infringement of biological products; S.1097, establishing an interagency task force between the Patent and Trademark Office and Food and Drug Administration; S.1095, the Stop STALLING Act, targeting sham citizen petitions filed to delay generic drug approval; and S.527, the Prescription Pricing for the People Act, requiring the Federal Trade Commission to study pharmaceutical supply chain intermediaries. The meeting also included consideration of the nomination of Patrick David Davis to be an Assistant Attorney General. As a business meeting rather than a hearing with testimony, no witnesses appeared before the committee. The bills aim to prevent anticompetitive practices in the pharmaceutical industry and promote access to affordable generic and biosimilar drugs. A business meeting does not guarantee these bills will advance to a vote.
Video
Watch videoCommittee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
Apr 10, 2025
Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
Apr 10, 2025
Committee on the Judiciary. Ordered to be reported with an amendment favorably.
Apr 3, 2025
HearingSenateMeeting
Apr 3, 2025 · 14:15
Business meeting to consider S.527, to require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, S.1040, to amend the Federal Trade Commission Act to prohibit product hopping, S.1041, to amend title 35, United States Code, to address the infringement of patents that claim biological products, S.1097, to amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, S.1095, to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and S.1096, to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products, and the nomination of Patrick David Davis, of Maryland, to be an Assistant Attorney General, Department of Justice.
Summary
On April 3, 2025, the Senate Judiciary Committee held a business meeting in Hart Senate Office Building to consider six bills aimed at increasing competition in the pharmaceutical market and reducing drug costs. The bills included S.1096, the Preserve Access to Affordable Generics and Biosimilars Act, which would prohibit brand-name drug companies from compensating generic drug manufacturers to delay market entry of generic drugs and biosimilar products. The committee also considered S.1040, addressing product hopping; S.1041, addressing patent infringement of biological products; S.1097, establishing an interagency task force between the Patent and Trademark Office and Food and Drug Administration; S.1095, the Stop STALLING Act, targeting sham citizen petitions filed to delay generic drug approval; and S.527, the Prescription Pricing for the People Act, requiring the Federal Trade Commission to study pharmaceutical supply chain intermediaries. The meeting also included consideration of the nomination of Patrick David Davis to be an Assistant Attorney General. As a business meeting rather than a hearing with testimony, no witnesses appeared before the committee. The bills aim to prevent anticompetitive practices in the pharmaceutical industry and promote access to affordable generic and biosimilar drugs. A business meeting does not guarantee these bills will advance to a vote.
Video
Watch videoCommittee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
Apr 10, 2025
Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
Apr 10, 2025
Congress
119th Congress
Introduced
Mar 13, 2025
