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.
Referred to the House Committee on Energy and Commerce.
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.
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