Preserve Access to Affordable Generics and Biosimilars Act
Sponsored By: Senator Amy Klobuchar
In Committee
Summary
Protects access to lower-cost generic and biosimilar medicines by targeting settlement deals that delay competitors. The bill would create a new Section 27 in the Federal Trade Commission Act that presumes certain patent settlements are anticompetitive when an ANDA or biosimilar filer gets value and agrees to limit competition.
Show full summary
- Families and patients: Could speed entry of generics and biosimilars by deterring pay-for-delay and other deals that postpone competition, which can improve access and pressure prices downward.
- Generic and biosimilar applicants: Creates a presumption of anticompetitive effects if they receive value and agree to limit research, manufacturing, marketing, or sales, while allowing rebuttal and a narrow safe harbor for claims of litigation expenses capped at $7.5 million in 2025 and adjusted later.
- Brand companies and regulators: Restricts common settlement options, exposes violators to civil penalties up to three times the value attributable to the violation and possible forfeiture of the first applicant's 180-day exclusivity. The FTC gets explicit authority to seek penalties and injunctions and the bill adds chief-officer certification and expanded notification rules for patent-related agreements.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Ban on anticompetitive drug deals
This bill would make most patent-settlement deals that keep cheaper generics or biosimilars off the market illegal. It would create a rebuttable presumption that a deal is anticompetitive when a generic or biosimilar applicant gets anything of value and agrees to limit research, making, marketing, or sales. The rule would not apply if the payment only repays promised goods or services, if procompetitive benefits outweigh harms, or if the deal is one of three safe harbors. Safe harbors include the right to market early, a covenant not to sue, or litigation costs up to $7,500,000 for 2025 (then indexed). The rule would apply to agreements made on or after enactment.
Stronger fines and generic exclusivity loss
This bill would let the FTC sue in federal court when it thinks a settlement broke the new rule. Courts could fine violators up to three times the value tied to the unlawful transfer, and judges must weigh harm, culpability, profits, ability to pay, and other factors when setting fines. The FTC must start such cases within six years after the Medicare filing certification is made. The bill would also let a finding under the new antitrust rule trigger loss of the first generic applicant's 180-day exclusivity, which could speed competing products to market.
CEO certification for Medicare drug filings
This bill would require the CEO or lead negotiator to file a certification within 30 days after filing certain drug-settlement agreements with DOJ and the FTC. The certification would say the filing is complete and list any side deals or oral promises. Filings would also have to notify patent owners and include agreements resolving Patent Trial and Appeal Board cases and similar proceedings. The change is meant to give regulators more visibility into settlement terms.
Sponsors & CoSponsors
Sponsor
Amy Klobuchar
MN • D
Cosponsors
Chuck Grassley
IA • R
Sponsored 3/24/2025
Richard Durbin
IL • D
Sponsored 3/24/2025
Kevin Cramer
ND • R
Sponsored 3/24/2025
Richard Blumenthal
CT • D
Sponsored 3/24/2025
Joni Ernst
IA • R
Sponsored 3/24/2025
Peter Welch
VT • D
Sponsored 3/24/2025
Mark Kelly
AZ • D
Sponsored 3/24/2025
Cory Booker
NJ • D
Sponsored 3/24/2025
Roll Call Votes
No roll call votes available for this bill.
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