Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014
Latest action · Dec 10, 2014 Sponsor introductory remarks on measure. (CR H8938)
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedNov 20, 2014
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.Cosponsors 4
Members who signed on, in the order they did. Signatures ran from Nov 20, 2014 to Dec 10, 2014, with 3 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-FL | Alcee L. Hastings | Original | Nov 20, 2014 |
| D-NC | G. K. Butterfield | Original | Nov 20, 2014 |
| R-TX | Michael T. McCaul | Original | Nov 20, 2014 |
| D-IL | Mike Quigley | Dec 10, 2014 |
Actions 4
Everything that happened, newest first.
- Dec 10, 2014Sponsor introductory remarks on measure. (CR H8938)
- Nov 21, 2014Referred to the Subcommittee on Health.
- Nov 20, 2014Introduced in House
- Nov 20, 2014Referred to the House Committee on Energy and Commerce.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Nov 20, 2014Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.
