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H.R. 938 · 116th Congress

BLOCKING Act of 2019

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019

What it does: CRS summary · Reported to House · May 2, 2019

Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019

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: BLOCKING Act of 2019

Also known as: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019

Latest action (May 2, 2019): Placed on the Union Calendar, Calendar No. 24.

Policy area: Health · Origin: House · Introduced: Jan 31, 2019

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.