PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Congressional Research Service
Version 00 · Introduced in House · Jan 4, 2021
Protecting Consumer Access to Generic Drugs Act of 2021
This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product.
Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)
Showing the opening paragraphs of the official summary.
Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill.
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 shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.
People & committees
Rep. Rush, Bobby L. [D-IL-1] · D–IL
Legislative record
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Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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 Energy and Commerce, and in addition to the Committee on the Judiciary, 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: Jan 3, 2025. Consult Congress.gov for the current record.
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