PlainBillCongress, translated.Legislation. Context. Public interest.Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.
Congressional Research Service
Version 00 · Introduced in House · Apr 28, 2021
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Nadler, Jerrold [D-NY-10] · D–NY
Legislative record
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Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.
Committee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
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.
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.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
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Analyze H.R.2891 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
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