H.R. 971 · 114th Congress
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BilirakisSponsor21 cosponsors · 5 D, 16 R
D
Butterfield
MM
R
McCaul
SG
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Graves
GG
R
Grothman
BP
R
Poliquin
JF
R
Fortenberry
CM
R
McMorris Rodgers
RD
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Davis
AH
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Hastings
MQ
D
Quigley
CG
R
Gibson
RN
R
Nugent
EP
R
Paulsen
SS
R
Scalise
JH
D
Huffman
BA
D
Ashford
DR
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Rohrabacher
RF
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Frelinghuysen
CS
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Smith
MF
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Fitzpatrick
LL
R
Lance2 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 2015
What it does: CRS summary · Introduced in House · Feb 13, 2015
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.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 2015
Latest action (Feb 20, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Feb 13, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.