Legis Daily

Protecting Consumer Access to Generic Drugs Act of 2019

USA116th CongressHR-1499| House 
| Updated: 5/10/2019
Bobby L. Rush

Bobby L. Rush

Democratic Representative

Illinois

Cosponsors (38)
Gilbert Ray Cisneros (Democratic)Chris Pappas (Democratic)Robin L. Kelly (Democratic)Joseph P. Kennedy (Democratic)James R. Langevin (Democratic)Ed Case (Democratic)Chrissy Houlahan (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)David Scott (Democratic)Debbie Dingell (Democratic)Steve Cohen (Democratic)Angie Craig (Democratic)Haley M. Stevens (Democratic)Ro Khanna (Democratic)André Carson (Democratic)John B. Larson (Democratic)Jim Cooper (Democratic)Doris O. Matsui (Democratic)Anna G. Eshoo (Democratic)Sharice Davids (Democratic)Abby Finkenauer (Democratic)Salud O. Carbajal (Democratic)Jamie Raskin (Democratic)Joe Neguse (Democratic)Mike Quigley (Democratic)Sean Casten (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Adam Smith (Democratic)Yvette D. Clarke (Democratic)Peter Welch (Democratic)Bennie G. Thompson (Democratic)Frank Pallone (Democratic)Alcee L. Hastings (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 20 19 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 must 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.

Bill Text Versions

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2 versions available

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Timeline
Mar 5, 2019
Introduced in House
Mar 5, 2019
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.
Mar 6, 2019
Referred to the Subcommittee on Health.
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported (Amended) by Voice Vote.
Apr 8, 2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
May 10, 2019
Placed on the Union Calendar, Calendar No. 30.
May 10, 2019
Committee on the Judiciary discharged.
May 10, 2019
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
  • March 5, 2019
    Introduced in House


  • March 5, 2019
    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.


  • March 6, 2019
    Referred to the Subcommittee on Health.


  • March 27, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • March 27, 2019
    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .


  • April 3, 2019
    Committee Consideration and Mark-up Session Held.


  • April 3, 2019
    Ordered to be Reported (Amended) by Voice Vote.


  • April 8, 2019
    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.


  • May 10, 2019
    Placed on the Union Calendar, Calendar No. 30.


  • May 10, 2019
    Committee on the Judiciary discharged.


  • May 10, 2019
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.

Health

Related Bills

  • HR 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • HR 116-987: Strengthening Health Care and Lowering Prescription Drug Costs Act
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 2019

USA116th CongressHR-1499| House 
| Updated: 5/10/2019
Protecting Consumer Access to Generic Drugs Act of 20 19 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 must 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.

Bill Text Versions

View Text
2 versions available

Suggested Questions

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

Timeline
Mar 5, 2019
Introduced in House
Mar 5, 2019
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.
Mar 6, 2019
Referred to the Subcommittee on Health.
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported (Amended) by Voice Vote.
Apr 8, 2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
May 10, 2019
Placed on the Union Calendar, Calendar No. 30.
May 10, 2019
Committee on the Judiciary discharged.
May 10, 2019
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
  • March 5, 2019
    Introduced in House


  • March 5, 2019
    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.


  • March 6, 2019
    Referred to the Subcommittee on Health.


  • March 27, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • March 27, 2019
    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .


  • April 3, 2019
    Committee Consideration and Mark-up Session Held.


  • April 3, 2019
    Ordered to be Reported (Amended) by Voice Vote.


  • April 8, 2019
    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.


  • May 10, 2019
    Placed on the Union Calendar, Calendar No. 30.


  • May 10, 2019
    Committee on the Judiciary discharged.


  • May 10, 2019
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
Bobby L. Rush

Bobby L. Rush

Democratic Representative

Illinois

Cosponsors (38)
Gilbert Ray Cisneros (Democratic)Chris Pappas (Democratic)Robin L. Kelly (Democratic)Joseph P. Kennedy (Democratic)James R. Langevin (Democratic)Ed Case (Democratic)Chrissy Houlahan (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)David Scott (Democratic)Debbie Dingell (Democratic)Steve Cohen (Democratic)Angie Craig (Democratic)Haley M. Stevens (Democratic)Ro Khanna (Democratic)André Carson (Democratic)John B. Larson (Democratic)Jim Cooper (Democratic)Doris O. Matsui (Democratic)Anna G. Eshoo (Democratic)Sharice Davids (Democratic)Abby Finkenauer (Democratic)Salud O. Carbajal (Democratic)Jamie Raskin (Democratic)Joe Neguse (Democratic)Mike Quigley (Democratic)Sean Casten (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Adam Smith (Democratic)Yvette D. Clarke (Democratic)Peter Welch (Democratic)Bennie G. Thompson (Democratic)Frank Pallone (Democratic)Alcee L. Hastings (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 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • HR 116-987: Strengthening Health Care and Lowering Prescription Drug Costs Act
  • 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