H.R. 971

Referred to Committee

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Introduced 2/13/2015•114th Congress•House

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Latest Action

Referred to the Subcommittee on Health.

2/20/2015 • House

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.

Introduced in House • 2/13/2015

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Topics & Subjects

Policy Area: Health

Administrative law and regulatory proceduresAdministrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs