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HR 5750 113th Congress House Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government information and archives Intellectual property Prescription drugs

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014

Introduced: November 20, 2014 Introduced by: Bilirakis, Gus M. Republican · Florida See on congress.gov
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 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 10, 2014
Sponsor introductory remarks on measure. (CR H8938)
Nov 21, 2014
Referred to the Subcommittee on Health.
Nov 20, 2014
Referred to the House Committee on Energy and Commerce.
Nov 20, 2014
Introduced in House
 Plain-English summary Congressional Research Service

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.
What's happening now December 10, 2014

Sponsor introductory remarks on measure. (CR H8938)

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Democratic 1 Republican 1