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US HR971

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015


summary

Introduced
02/13/2015
In Committee
02/20/2015
Crossed Over
Passed
Dead
01/03/2017

Introduced Session

114th Congress

Bill Summary

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an "orphan disease"). Allows the FDA to revoke an extension if the application for the new indication contained an untrue material statement. Requires the sponsor of a product receiving an extension to notify the FDA one year prior to discontinuing production for commercial reasons. Requires the FDA to notify the public of products that receive this extension and patents related to those products. Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions. Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (22)

Last Action

Referred to the Subcommittee on Health. (on 02/20/2015)

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