H.R. 2853 · 117th Congress
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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SchraderSponsorNo cosponsors.
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021
What it does: CRS summary · Introduced in House · Apr 26, 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Also known as: BLOCKING Act of 2021
Latest action (Apr 27, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 26, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.