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Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
1/11/2023, 1:28 PM
Congressional Summary of HR 971
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.
