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United States · Bill · HR

H.R. 2375 (116th)

Preserve Access to Affordable Generics and Biosimilars Act

openUnited States· United States Congress· EN

Introduced

29 April 2019

Last action

24 December 2020 · Reported

Status

Placed on the Union Calendar, Calendar No. 576.

Sponsors

Rep. Nadler, Jerrold [D-NY-12], Rep. Collins, Doug [R-GA-9], Rep. Cicilline, David N. [D-RI-1], Rep. Cohen, Steve [D-TN-9], Rep. Meadows, Mark [R-NC-11]

Subjects

Healthcare

Source updated

7 April 2025

Healthcare

Official sourceDownload fileView documentsShare

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. 29 April 2019

    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. 29 April 2019

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 29 April 2019

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 30 April 2019

    Reported

    Ordered to be Reported by Voice Vote.

    Source: Committee

  5. 30 April 2019

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  6. 30 April 2019

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  7. 24 December 2020

    Calendars

    Placed on the Union Calendar, Calendar No. 576.

    Source: Calendars

  8. 24 December 2020

    Discharge

    Committee on Energy and Commerce discharged.

    Source: Discharge

  9. 24 December 2020

    Committee

    Committee on Energy and Commerce discharged.

    Source: Committee

  10. 24 December 2020

    Reported

    Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.

    Source: Committee

  11. 24 December 2020

    Reported

    Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

6 official files

Reported in House (text)

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  • Reported in House (text)

    Reported in House · EN · 24 December 2020

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  • Reported in House (PDF)

    Reported in House · EN · 24 December 2020

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  • Reported to House, Part I

    summary · EN · 24 December 2020

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  • Introduced in House (text)

    Introduced in House · EN · 29 April 2019

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  • Introduced in House (PDF)

    Introduced in House · EN · 29 April 2019

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  • Introduced in House

    summary · EN · 29 April 2019

    Open at official source

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Sponsors

Related records

Sources

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