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Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Introduced: February 13, 2015 Introduced by: Bilirakis, Gus M. Republican · Florida See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 20, 2015
Referred to the Subcommittee on Health.
Feb 13, 2015
Referred to the House Committee on Energy and Commerce.
Feb 13, 2015
Introduced in House
 Plain-English summary Congressional Research Service

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.
What's happening now February 20, 2015

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 7
All 7 Democratic 2 Republican 5