Preserve Access to Affordable Generics and Biosimilars Act
Senate Committee Advances Bill to Ban "Pay-for-Delay" Drug Deals That Keep Generics Off Market
Stalled
No legislative action in over 90 days.
Legislative Progress
Key Points
- Congress would crack down on deals where a brand-name drug company gives something of value to a generic or biosimilar maker to wait longer before selling a cheaper alternative.
- These “pay-for-delay” settlements would be presumed illegal when the generic or biosimilar company gets value and agrees to pause or limit making, marketing, or selling the lower-cost drug.
- The Federal Trade Commission could take companies to court and seek penalties of up to 3 times the value tied to the illegal deal, plus court orders to stop the behavior.
- The bill allows some settlement terms, like letting a generic launch before a patent ends, paying reasonable legal costs (up to $7.5 million in 2025, adjusted after), or agreeing not to sue.
- Drug companies would also have to certify that they turned over the full, complete agreement and any side deals to federal enforcers, making it harder to hide delay agreements.
Impact Analysis
Personal Impact
How this policy affects specific groups of people
Milestones
Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
The bill is now on the schedule for the full chamber to consider. It's in line for debate and a vote.
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Read twice and referred to the Committee on the Judiciary.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
Votes
No votes have been recorded for this legislation yet.
Related News
4 articlesSenate takes aim at pharma's patent schemes, pay-for-delay deals in renewed drug pricing crackdown
The Preserve Access to Affordable Generics and Biosimilars Act would limit “pay-for-delay” deals in which companies compensate generic manufacturers to delay the entrance of their products into the market. Sen. Amy Klobuchar explained the bill targets agreements raising serious competitive concerns.
Drug Industry Patents Go Under Senate Judiciary Committee’s Microscope
Klobuchar and Grassley teamed up on the Preserve Access to Affordable Generics and Biosimilars Act, which they say would end “anti-competitive behavior” — specifically, deals struck between branded companies and generic companies to keep a generic, or a biosimilar, off the market.
Senators target pay-for-delay pharma deals
U.S. Senators Amy Klobuchar and Chuck Grassley reintroduced legislation that would make it illegal for brand-name drug manufacturers to pay-off other drug manufacturers to keep generic versions of brand-name drugs off the market, citing FTC reports on the high cost of these settlements.
Source Information
Document Type
Congressional Bill
Official Title
Preserve Access to Affordable Generics and Biosimilars Act
Data Sources
Sponsor
Cosponsors
(8)Analysis generated by AI. Always verify with official sources.