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HR 5750 113th Congress House

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014

Official title: To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subseq… Show full official titleShow less

Official title: To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes.

Introduced: December 10, 2014 Introduced by: Bilirakis, Gus M. Republican · Florida See on congress.gov
Health Administrative law and regulatory proceduresAdministrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation
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Drug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs
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This bill died when the 113th Congress ended
It never became law before the 113th Congress (2013–2014) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
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 Latest action December 10, 2014

Sponsor introductory remarks on measure. (CR H8938)

 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.
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Democratic 1 Republican 1
D
Quigley, Mike
Illinois · Dec 10, 2014
Butterfield, G. K.
· Nov 20, 2014
 R
McCaul, Michael T.
Texas · Nov 20, 2014
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5750: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014. 113th Congress. Open America. https://openamerica.io/bill/113-HR-5750/
MLA
"H.R. 5750: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-5750/.
Bluebook (legal)
H.R. 5750, 113th Cong. (2026), https://openamerica.io/bill/113-HR-5750/.
Markdown link
[H.R. 5750: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014](https://openamerica.io/bill/113-HR-5750/)
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