Amy Klobuchar (D-MN)
Preserve Access to Affordable Generics and Biosimilars Act
A Democratic bill with 3 Republican cosponsors · See all 8 cosponsors
Last activity — Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
Cleared committee, waiting for its first floor vote
A committee approved it and it is on the calendar of the chamber it started in.
This is further than most bills get, and still no promise of a vote: the calendar is a queue, and the majority leadership decides what is called. A bill can sit here until the Congress ends.
Its path through Congress
- Introduced
- On Calendar
What this bill would do
This bill, titled the "Preserve Access to Affordable Generics and Biosimilars Act," aims to stop brand name drug companies from paying generic competitors to delay their entry into the market. It also targets biological product manufacturers who use similar tactics to block biosimilar and interchangeable products. By prohibiting these "reverse payment" settlement agreements, the bill seeks to increase competition and lower costs for consumers. The legislation updates the Federal Trade Commission Act to treat these specific agreements as unfair methods of competition. It provides the Federal Trade Commission with the authority to bring civil actions and seek penalties against violators.
Yes· 3 of 6
- Scored +8
Does this lower the price of prescription medicines?
By preventing brand-name companies from paying generic competitors to delay market entry, the bill facilitates lower-cost drug competition.
- Scored +7
Does this make health care easier to get in general?
The bill increases patient access to medicines by promoting the earlier entry of affordable generic and biosimilar products.
- Scored +7
Does this give people more protection from unfair business practices?
The bill prohibits anticompetitive 'reverse payment' settlement agreements that delay access to affordable generic and biosimilar drugs.
The opposite
- Scored -4
Would business owners be better off under this?
Brand-name pharmaceutical companies face stricter regulations and higher risks of civil penalties for existing settlement practices.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Competition and Lower Costs: By stopping agreements that delay the marketing of low-cost generic and biosimilar drugs, the bill intends to enhance competition in the pharmaceutical market (Section 2(b)(1)).
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Improved Patient Access: Competition from biosimilar and interchangeable biological products is expected to increase patient access to biological medicines (Section 2(a)(9)).
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Protection Against Unfair Business Practices: The bill treats certain settlement agreements as unfair methods of competition, providing a legal mechanism to prevent branded companies from sharing monopoly profits with competitors to protect their own monopolies (Section 3(a)(1) and Section 2(a)(6)(B)(i)).
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Deterrence through Penalties: The bill establishes civil penalties of up to three times the value received to deter companies from entering into anticompetitive agreements (Section 3(a)(5)(A)).
Potential Negative Impacts for People
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Exceptions to the Prohibition: The law does not apply to certain settlements, such as those providing for reasonable litigation expenses up to a specific limit (Section 3(b)(2)), which may allow some types of payments to continue.
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Burden of Proof for Exceptions: Parties can avoid the presumption of anticompetitive effects if they can demonstrate by a preponderance of the evidence that the value was for other goods or services, or that procompetitive benefits outweigh the anticompetitive effects (Section 3(a)(3)(B)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Tap or hover a score for the reason it gave.
- Healthcare
- Does this lower the price of prescription medicines? — By preventing brand-name companies from paying generic competitors to delay market entry, the bill facilitates lower-cost drug competition. Does this make health care easier to get in general? — The bill increases patient access to medicines by promoting the earlier entry of affordable generic and biosimilar products.
- Economy And Finance
- Does this give people more protection from unfair business practices? — The bill prohibits anticompetitive 'reverse payment' settlement agreements that delay access to affordable generic and biosimilar drugs.
- Demographic And Interest Groups
- Would households on low incomes be better off under this? — Lower costs for essential medications benefit those with limited financial resources. Would middle-income households be better off under this? — Increased competition for drugs can lower overall healthcare spending for middle-income families. Would business owners be better off under this? — Brand-name pharmaceutical companies face stricter regulations and higher risks of civil penalties for existing settlement practices.
- Social Issues And Justice
- Is this likely to lift people out of poverty? — Lowering prescription drug costs can increase the disposable income of low-income households.
- 4/10/2025
- Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
- 4/3/2025
- Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 3/24/2025
- Read twice and referred to the Committee on the Judiciary.
- 8 Cosponsors added.
- Introduced in Senate
Richard BlumenthalDemocrat · Connecticut
Cory BookerDemocrat · New Jersey
Kevin CramerRepublican · North Dakota
Richard DurbinDemocrat · Illinois
Joni ErnstRepublican · Iowa
Chuck GrassleyRepublican · Iowa
Mark KellyDemocrat · Arizona
Peter WelchDemocrat · Vermont