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Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
1/11/2023, 1:31 PM
Congressional Summary of S 1421
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) 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 HHS to revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.
Requires the sponsor of a product receiving an extension to notify HHS one year prior to discontinuing production for commercial reasons.
Requires HHS 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.
