Preserve Access to Affordable Generics and Biosimilars Act

Summary

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.

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

Timeline

1. 28 April 2021

   Introduced

   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.

   Source: IntroReferral

2. 28 April 2021

   Introduced

   Introduced in House

   Source: IntroReferral

3. 28 April 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 29 April 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 29 September 2021

   Vote

   Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.

   Source: Committee

6. 29 September 2021

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 28 April 2021 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 28 April 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 28 April 2021

  ViewDownloadOpen 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.

• Introduced in House

  summary · EN · 28 April 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. Nadler, Jerrold [D-NY-12] · D · Sponsor
• Rep. Cicilline, David N. [D-RI-1] · D · Sponsor
• Rep. Buck, Ken [R-CO-4] · R · Sponsor
• Rep. Maloney, Carolyn B. [D-NY-12] · D · Sponsor
• Rep. Owens, Burgess [R-UT-4] · R · Cosponsor
• Del. Norton, Eleanor Holmes [D-DC-At Large] · D · Cosponsor
• Sen. Budd, Ted [R-NC] · R · Cosponsor
• Rep. Jackson Lee, Sheila [D-TX-18] · D · Cosponsor
• · hsju00 · Standing
• · hsif00 · Standing

Related records

• related to ← Preserve Access to Affordable Generics and Biosimilars Act
• related to ← Reduced Costs and Continued Cures Act of 2021
• related to ← Reduced Costs and Continued Cures Act
• related to ← Preserve Access to Affordable Generics and Biosimilars Act