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Protecting Consumer Access to Generic Drugs Act of 2021

USA117th CongressHR-153| House 
| Updated: 3/4/2021
Bobby L. Rush

Bobby L. Rush

Democratic Representative

Illinois

Cosponsors (18)
Lisa Blunt Rochester (Democratic)David J. Trone (Democratic)Ed Case (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)David Scott (Democratic)Steve Cohen (Democratic)Ro Khanna (Democratic)John B. Larson (Democratic)Mark DeSaulnier (Democratic)Joe Neguse (Democratic)Sean Casten (Democratic)Janice D. Schakowsky (Democratic)Adam Smith (Democratic)Peter Welch (Democratic)Gerald E. Connolly (Democratic)Lauren Underwood (Democratic)Susan Wild (Democratic)

Administrative State, Regulatory Reform, and Antitrust Subcommittee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee

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

Bill from Previous Congress

HR 116-1499
Protecting Consumer Access to Generic Drugs Act of 2019
Jan 4, 2021
Introduced in House
Jan 4, 2021
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.
Feb 2, 2021
Referred to the Subcommittee on Health.
Mar 4, 2021
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
  • Bill from Previous Congress

    HR 116-1499
    Protecting Consumer Access to Generic Drugs Act of 2019


  • January 4, 2021
    Introduced in House


  • January 4, 2021
    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.


  • February 2, 2021
    Referred to the Subcommittee on Health.


  • March 4, 2021
    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

Health

Related Bills

  • HR 117-19: Lower Costs, More Cures Act of 2021
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsPrescription drugs

Protecting Consumer Access to Generic Drugs Act of 2021

USA117th CongressHR-153| House 
| Updated: 3/4/2021
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.) 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.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-1499
Protecting Consumer Access to Generic Drugs Act of 2019
Jan 4, 2021
Introduced in House
Jan 4, 2021
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.
Feb 2, 2021
Referred to the Subcommittee on Health.
Mar 4, 2021
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
  • Bill from Previous Congress

    HR 116-1499
    Protecting Consumer Access to Generic Drugs Act of 2019


  • January 4, 2021
    Introduced in House


  • January 4, 2021
    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.


  • February 2, 2021
    Referred to the Subcommittee on Health.


  • March 4, 2021
    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Bobby L. Rush

Bobby L. Rush

Democratic Representative

Illinois

Cosponsors (18)
Lisa Blunt Rochester (Democratic)David J. Trone (Democratic)Ed Case (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)David Scott (Democratic)Steve Cohen (Democratic)Ro Khanna (Democratic)John B. Larson (Democratic)Mark DeSaulnier (Democratic)Joe Neguse (Democratic)Sean Casten (Democratic)Janice D. Schakowsky (Democratic)Adam Smith (Democratic)Peter Welch (Democratic)Gerald E. Connolly (Democratic)Lauren Underwood (Democratic)Susan Wild (Democratic)

Administrative State, Regulatory Reform, and Antitrust Subcommittee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee

Health

Related Bills

  • HR 117-19: Lower Costs, More Cures Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsPrescription drugs