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HR 2375 116th Congress House Health Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Congressional oversight Contracts and agency Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Marketing and advertising Prescription drugs

Preserve Access to Affordable Generics and Biosimilars Act

Introduced: April 29, 2019 Introduced by: Nadler, Jerrold Democratic · New York See on congress.gov
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 8 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 24, 2020
Placed on the Union Calendar, Calendar No. 576.
Dec 24, 2020
Committee on Energy and Commerce discharged.
Dec 24, 2020
Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.
Apr 30, 2019
Referred to the Subcommittee on Health.
Apr 30, 2019
Ordered to be Reported by Voice Vote.
Apr 30, 2019
Committee Consideration and Mark-up Session Held.
Apr 29, 2019
Introduced in House
Apr 29, 2019
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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 Plain-English summary Congressional Research Service

Preserve Access to Affordable Generics and Biosimilars Act

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.

An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market 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.

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.

The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

What's happening now December 24, 2020

Placed on the Union Calendar, Calendar No. 576.

 Related & companion bills 2
  • S 64 Related bill Preserve Access to Affordable Generics and Biosimilars Act
  • HR 1344 Related bill Competitive DRUGS Act of 2019
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
 Cosponsors 4
All 4 Democratic 1
Meadows, Mark
· May 7, 2019
 D
Cohen, Steve
Tennessee · Apr 30, 2019
Cicilline, David
· Apr 29, 2019
Collins, Doug
· Apr 29, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act. 116th Congress. Open America. https://openamerica.io/bill/116-HR-2375/
MLA
"H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-2375/.
Bluebook (legal)
H.R. 2375, 116th Cong. (2026), https://openamerica.io/bill/116-HR-2375/.
Markdown link
[H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act](https://openamerica.io/bill/116-HR-2375/)
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