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Increasing Prescription Drug Competition Act

USA118th CongressHR-4692| House 
| Updated: 7/21/2023
Elissa Slotkin

Elissa Slotkin

Democratic Representative

Michigan

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Increasing Prescription Drug Competition Act This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.) Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.
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Timeline
Mar 1, 2023

Latest Companion Bill Action

S 118-574
Introduced in Senate
Jul 17, 2023
Introduced in House
Jul 17, 2023
Referred to the House Committee on Energy and Commerce.
Jul 21, 2023
Referred to the Subcommittee on Health.
  • March 1, 2023

    Latest Companion Bill Action

    S 118-574
    Introduced in Senate


  • July 17, 2023
    Introduced in House


  • July 17, 2023
    Referred to the House Committee on Energy and Commerce.


  • July 21, 2023
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 118-574: Increasing Prescription Drug Competition Act
Civil actions and liabilityDrug safety, medical device, and laboratory regulationPrescription drugs

Increasing Prescription Drug Competition Act

USA118th CongressHR-4692| House 
| Updated: 7/21/2023
Increasing Prescription Drug Competition Act This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.) Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.
View Full Text

Suggested Questions

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

Timeline
Mar 1, 2023

Latest Companion Bill Action

S 118-574
Introduced in Senate
Jul 17, 2023
Introduced in House
Jul 17, 2023
Referred to the House Committee on Energy and Commerce.
Jul 21, 2023
Referred to the Subcommittee on Health.
  • March 1, 2023

    Latest Companion Bill Action

    S 118-574
    Introduced in Senate


  • July 17, 2023
    Introduced in House


  • July 17, 2023
    Referred to the House Committee on Energy and Commerce.


  • July 21, 2023
    Referred to the Subcommittee on Health.
Elissa Slotkin

Elissa Slotkin

Democratic Representative

Michigan

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 118-574: Increasing Prescription Drug Competition Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Civil actions and liabilityDrug safety, medical device, and laboratory regulationPrescription drugs