H.R. 5750 · 113th Congress
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014
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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BilirakisSponsor4 cosponsors · 3 D, 1 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary 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…
What it does: CRS summary · Introduced in House · Nov 20, 2014
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary 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 the Secretary 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 the Secretary to notify the public of products that receive this extension.
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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014
Latest action (Dec 10, 2014): Sponsor introductory remarks on measure. (CR H8938)
Policy area: Health · Origin: House · Introduced: Nov 20, 2014
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.