US Congress House Bill 971 (Prior Session Legislation)

---

Sponsorship: Moderate Partisan Bill (Republican 17-5)
Status: Introduced on February 13 2015 - 25% progression, died in committee
Action: 2015-02-20 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Rep. Gus Bilirakis [R-FL]	Rep. Michael McCaul [R-TX]	Rep. G. Butterfield [D-NC]	Rep. Bruce Poliquin [R-ME]
Rep. Sam Graves [R-MO]	Rep. Glenn Grothman [R-WI]	Rep. Jeff Fortenberry [R-NE]	Rep. Cathy McMorris Rodgers [R-WA]
Rep. Alcee Hastings [D-FL]	Rep. Rodney Davis [R-IL]	Rep. Mike Quigley [D-IL]	Rep. Richard Nugent [R-FL]
Rep. Christopher Gibson [R-NY]	Rep. Erik Paulsen [R-MN]	Rep. Steve Scalise [R-LA]	Rep. Jared Huffman [D-CA]
Rep. Dana Rohrabacher [R-CA]	Rep. Brad Ashford [D-NE]	Rep. Rodney Frelinghuysen [R-NJ]	Rep. Christopher Smith [R-NJ]
Rep. Michael Fitzpatrick [R-PA]	Rep. Leonard Lance [R-NJ]

Date	Chamber	Action
2015-02-20	House	Referred to the Subcommittee on Health.
2015-02-13	House	Referred to the House Committee on Energy and Commerce.
2015-02-13	House	Introduced in House

SB1421 (Related) 2015-05-21 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/971/all-info
Text	https://www.congress.gov/114/bills/hr971/BILLS-114hr971ih.pdf