Legis Daily

Affordable Prescriptions for Patients Act of 2019

USA116th CongressS-1416| Senate 
| Updated: 6/28/2019
John Cornyn

John Cornyn

Republican Senator

Texas

Cosponsors (13)
Rick Scott (Republican)Richard J. Durbin (Democratic)Angus S. King (Independent)Martha McSally (Republican)John Kennedy (Republican)Deb Fischer (Republican)Patty Murray (Democratic)Tina Smith (Democratic)Josh Hawley (Republican)Gary C. Peters (Democratic)Patrick Toomey (Republican)Richard Blumenthal (Democratic)Shelley Moore Capito (Republican)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Affordable Prescriptions for Patients Act of 2019 This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch . A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition. A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product. A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition. This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.

Bill Text Versions

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2 versions available

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Timeline
May 9, 2019
Introduced in Senate
May 9, 2019
Read twice and referred to the Committee on the Judiciary.
Jun 27, 2019
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jun 28, 2019
Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
Jun 28, 2019
Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
  • May 9, 2019
    Introduced in Senate


  • May 9, 2019
    Read twice and referred to the Committee on the Judiciary.


  • June 27, 2019
    Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • June 28, 2019
    Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.


  • June 28, 2019
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.

Commerce

Related Bills

  • HR 116-5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
  • HR 116-3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019
  • HR 116-4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs

Affordable Prescriptions for Patients Act of 2019

USA116th CongressS-1416| Senate 
| Updated: 6/28/2019
Affordable Prescriptions for Patients Act of 2019 This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch . A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition. A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product. A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition. This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.

Bill Text Versions

View Text
2 versions available

Suggested Questions

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

Timeline
May 9, 2019
Introduced in Senate
May 9, 2019
Read twice and referred to the Committee on the Judiciary.
Jun 27, 2019
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jun 28, 2019
Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
Jun 28, 2019
Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
  • May 9, 2019
    Introduced in Senate


  • May 9, 2019
    Read twice and referred to the Committee on the Judiciary.


  • June 27, 2019
    Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • June 28, 2019
    Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.


  • June 28, 2019
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
John Cornyn

John Cornyn

Republican Senator

Texas

Cosponsors (13)
Rick Scott (Republican)Richard J. Durbin (Democratic)Angus S. King (Independent)Martha McSally (Republican)John Kennedy (Republican)Deb Fischer (Republican)Patty Murray (Democratic)Tina Smith (Democratic)Josh Hawley (Republican)Gary C. Peters (Democratic)Patrick Toomey (Republican)Richard Blumenthal (Democratic)Shelley Moore Capito (Republican)

Judiciary Committee

Commerce

Related Bills

  • HR 116-5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
  • HR 116-3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019
  • HR 116-4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs