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Preserve Access to Affordable Generics and Biosimilars Act

USA117th CongressHR-2891| House 
| Updated: 9/29/2021
Jerrold Nadler

Jerrold Nadler

Democratic Representative

New York

Cosponsors (7)
David N. Cicilline (Democratic)Sheila Jackson Lee (Democratic)Carolyn B. Maloney (Democratic)Ken Buck (Republican)Eleanor Holmes Norton (Democratic)Burgess Owens (Republican)Ted Budd (Republican)

Health Subcommittee, Judiciary Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline

Bill from Previous Congress

HR 116-2375
Preserve Access to Affordable Generics and Biosimilars Act
Apr 28, 2021
Introduced in House
Apr 28, 2021
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.
Apr 29, 2021
Referred to the Subcommittee on Health.
Sep 29, 2021
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.
Sep 29, 2021
Committee Consideration and Mark-up Session Held.
Dec 9, 2021

Latest Companion Bill Action

S 117-1428
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
  • Bill from Previous Congress

    HR 116-2375
    Preserve Access to Affordable Generics and Biosimilars Act


  • April 28, 2021
    Introduced in House


  • April 28, 2021
    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.


  • April 29, 2021
    Referred to the Subcommittee on Health.


  • September 29, 2021
    Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.


  • September 29, 2021
    Committee Consideration and Mark-up Session Held.


  • December 9, 2021

    Latest Companion Bill Action

    S 117-1428
    Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.

Health

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • S 117-1428: Preserve Access to Affordable Generics and Biosimilars Act
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsManufacturingMarketing and advertisingPrescription drugs

Preserve Access to Affordable Generics and Biosimilars Act

USA117th CongressHR-2891| House 
| Updated: 9/29/2021
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. 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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-2375
Preserve Access to Affordable Generics and Biosimilars Act
Apr 28, 2021
Introduced in House
Apr 28, 2021
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.
Apr 29, 2021
Referred to the Subcommittee on Health.
Sep 29, 2021
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.
Sep 29, 2021
Committee Consideration and Mark-up Session Held.
Dec 9, 2021

Latest Companion Bill Action

S 117-1428
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
  • Bill from Previous Congress

    HR 116-2375
    Preserve Access to Affordable Generics and Biosimilars Act


  • April 28, 2021
    Introduced in House


  • April 28, 2021
    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.


  • April 29, 2021
    Referred to the Subcommittee on Health.


  • September 29, 2021
    Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.


  • September 29, 2021
    Committee Consideration and Mark-up Session Held.


  • December 9, 2021

    Latest Companion Bill Action

    S 117-1428
    Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
Jerrold Nadler

Jerrold Nadler

Democratic Representative

New York

Cosponsors (7)
David N. Cicilline (Democratic)Sheila Jackson Lee (Democratic)Carolyn B. Maloney (Democratic)Ken Buck (Republican)Eleanor Holmes Norton (Democratic)Burgess Owens (Republican)Ted Budd (Republican)

Health Subcommittee, Judiciary Committee, Energy and Commerce Committee

Health

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • S 117-1428: Preserve Access to Affordable Generics and Biosimilars Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsManufacturingMarketing and advertisingPrescription drugs