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BLOCKING Act of 2021

USA117th CongressHR-2853| House 
| Updated: 4/27/2021
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
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Timeline

Bill from Previous Congress

HR 116-938
BLOCKING Act of 2019
Apr 26, 2021
Introduced in House
Apr 26, 2021
Referred to the House Committee on Energy and Commerce.
Apr 27, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-938
    BLOCKING Act of 2019


  • April 26, 2021
    Introduced in House


  • April 26, 2021
    Referred to the House Committee on Energy and Commerce.


  • April 27, 2021
    Referred to the Subcommittee on Health.

Health

Competition and antitrustDrug safety, medical device, and laboratory regulationHealth care costs and insuranceHealth care coverage and accessLicensing and registrationsMarketing and advertisingPrescription drugs

BLOCKING Act of 2021

USA117th CongressHR-2853| House 
| Updated: 4/27/2021
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-938
BLOCKING Act of 2019
Apr 26, 2021
Introduced in House
Apr 26, 2021
Referred to the House Committee on Energy and Commerce.
Apr 27, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-938
    BLOCKING Act of 2019


  • April 26, 2021
    Introduced in House


  • April 26, 2021
    Referred to the House Committee on Energy and Commerce.


  • April 27, 2021
    Referred to the Subcommittee on Health.
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustDrug safety, medical device, and laboratory regulationHealth care costs and insuranceHealth care coverage and accessLicensing and registrationsMarketing and advertisingPrescription drugs