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HR 971 114th Congress House

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

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: April 15, 2015 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 114th Congress ended
It never became law before the 114th Congress (2015–2016) 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 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
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 Latest action February 20, 2015

Referred to the Subcommittee on Health.

 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.
 Related & companion bills 1
  • S 1421 Related bill Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 10
All 10 Democratic 2 Republican 5
R
Smith, Christopher H.
New Jersey · May 13, 2016
FRELINGHUYSEN, RODNEY
· Mar 17, 2016
ROHRABACHER, DANA
· Mar 7, 2016
 D
Huffman, Jared
California · Jun 2, 2015
 R
Scalise, Steve
Louisiana · May 13, 2015
 D
Quigley, Mike
Illinois · Apr 15, 2015
 R
Graves, Sam
Missouri · Mar 3, 2015
 R
Grothman, Glenn
Wisconsin · Mar 3, 2015
Poliquin, Bruce
· Mar 3, 2015
 R
McCaul, Michael T.
Texas · Feb 13, 2015
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015. 114th Congress. Open America. https://openamerica.io/bill/114-HR-971/
MLA
"H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-971/.
Bluebook (legal)
H.R. 971, 114th Cong. (2026), https://openamerica.io/bill/114-HR-971/.
Markdown link
[H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015](https://openamerica.io/bill/114-HR-971/)
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