Wildland Firefighters Congressional Gold Medal Act
In Committee
Introduced:Sep 16, 2025
Primary Sponsor
Amy Klobuchar
D - MN
Cosponsors
10
Quick Stats
Policy Area
Health
Summary
This bill aims to prevent drug companies from making deals that delay the release of cheaper generic and biosimilar drugs. It gives the Federal Trade Commission the power to go after any agreements where a brand-name drug maker pays a generic or biosimilar maker to hold off on releasing their product.
Latest Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
AI Summary
Plain-English explanation of this bill
This bill aims to prevent drug companies from making deals that delay the release of cheaper generic and biosimilar drugs. It gives the Federal Trade Commission the power to go after any agreements where a brand-name drug maker pays a generic or biosimilar maker to hold off on releasing their product.
Last updated: 12/29/2025
Official Summary
Congressional Research Service summary
<p><b>Preserve Access to Affordable Generics and Biosimilars Act</b></p> <p>This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.</p> <p>An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.</p> <p> When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.</p> <p>The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.</p>
Key Points
Main provisions of the bill
Authorizes the FTC to take action against drug company agreements that delay cheaper generic and biosimilar drug releases
Presumes that any agreement where a generic/biosimilar maker receives payment to limit their product is anticompetitive and illegal
Allows some exceptions, like allowing the generic/biosimilar to launch early or covering litigation costs
How This Impacts Americans
Potential effects on citizens and communities
This bill would impact consumers by potentially speeding up the availability of less expensive generic and biosimilar drugs, saving people money on their medications. It would also affect brand-name and generic/biosimilar drug companies, limiting their ability to make deals that delay competition.
Policy Areas
Primary Policy Area
Health
Related Subjects
Administrative law and regulatory procedures
Civil actions and liability
Competition and antitrust
Contracts and agency
Federal Trade Commission (FTC)
Intellectual property
Judicial review and appeals
Licensing and registrations
Manufacturing
Marketing and advertising
+1 more
Scope & Jurisdiction
Jurisdiction Level
federal
Congressional Session
119th Congress
Citation Reference
142, 119th Congress (2025). "Wildland Firefighters Congressional Gold Medal Act". Source: Voter's Right Platform. https://votersright.org/bills/118-s-142