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Bill > HR938


US HR938

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


summary

Introduced
01/31/2019
In Committee
04/03/2019
Crossed Over
Passed
Dead
12/31/2020

Introduced Session

116th Congress

Bill Summary

A BILL To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. HR 938 RH 3 1

AI Summary

This bill, known as the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, aims to amend the Federal Food, Drug, and Cosmetic Act to remove the barrier posed by the 180-day exclusivity period granted to the first generic drug applicant that has not yet received final approval. The bill would allow for the approval of subsequent generic drugs in situations where the first generic applicant has not yet received final approval, as long as certain conditions are met, such as at least 30 months having passed since the submission of an application by a first applicant and no application from a first applicant being approved at the time the conditions are met.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (17)

Last Action

Placed on the Union Calendar, Calendar No. 24. (on 05/02/2019)

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