Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Summary
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.
Bill status
in committee
1 of 4 stages cleared
Introduction
Apr 2021
Committee Review
Floor Vote
President
Introduced Apr 26, 2021
Last action Apr 27, 2021
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
3
Key actions
0
Committee
2
Apr 27, 2021
Committee
Referred to the Subcommittee on Health.
lower
Apr 26, 2021
Committee
Referred to the House Committee on Energy and Commerce.
lower
Apr 26, 2021
Introduced
Introduced in House
lower
1 primary · 0 co-sponsors
Sponsors
Role
Legislator
Party
State
District
P
Kurt Schrader
DDemocratic
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