Proposal:BLOCKING Act of 2021

This proposal is archived and closed to further debate. It was introduced in the 117th Congress, which has concluded, and the bill was not enacted into law.

Bill	HR 2853
Type of Legislation	House Bill
Congress	117
Status	Archived — 117th Congress concluded
Source	View original on Congress.gov

Geographic Scope

National

Description

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 Title

BLOCKING Act of 2021

Linked Goals

• Goal:Promote General Welfare

Steps

• 2021-04-26: Referred to the House Committee on Energy and Commerce.
• 2021-04-26: Introduced in House
• 2021-04-26: Introduced in House
• 2021-04-27: Referred to the Subcommittee on Health.

Projected Outcome

A more informed proposal or public response aligned with the Promote General Welfare goal.