Protecting Consumer Access to Generic Drugs Act of 2021

Summary

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.) 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 4 January 2021

   Introduced

   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.

   Source: IntroReferral

2. 4 January 2021

   Introduced

   Introduced in House

   Source: IntroReferral

3. 4 January 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 2 February 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 4 March 2021

   Referred

   Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 4 January 2021 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 4 January 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 4 January 2021

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in House

  summary · EN · 4 January 2021

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Rush, Bobby L. [D-IL-1] · D · Sponsor
• Rep. Casten, Sean [D-IL-6] · D · Sponsor
• Rep. Cohen, Steve [D-TN-9] · D · Sponsor
• Rep. Connolly, Gerald E. [D-VA-11] · D · Sponsor
• Rep. DeSaulnier, Mark [D-CA-10] · D · Sponsor
• Rep. Neguse, Joe [D-CO-2] · D · Sponsor
• Rep. Ruiz, Raul [D-CA-25] · D · Sponsor
• Rep. Underwood, Lauren [D-IL-14] · D · Sponsor
• Rep. Van Drew, Jefferson [R-NJ-2] · R · Sponsor
• David Scott · D · Cosponsor
• Sen. Welch, Peter [D-VT] · D · Cosponsor
• Rep. Schakowsky, Janice D. [D-IL-9] · D · Cosponsor
• Rep. Trone, David J. [D-MD-6] · D · Cosponsor
• Rep. Khanna, Ro [D-CA-17] · D · Cosponsor
• Rep. Larson, John B. [D-CT-1] · D · Cosponsor
• Sen. Blunt Rochester, Lisa [D-DE] · D · Cosponsor
• Rep. Case, Ed [D-HI-1] · D · Cosponsor
• Rep. Smith, Adam [D-WA-9] · D · Cosponsor
• Rep. Wild, Susan [D-PA-7] · D · Cosponsor
• · hsju00 · Standing
• · hsif00 · Standing

Related records

• related to ← Lower Costs, More Cures Act of 2021