Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Bill journey · stage 2 of 5
Under committee review
What it doesSummary 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.What just happenedFeb 20, 2015
Referred to the Subcommittee on Health.
Who’s behind it
- Introduced in HouseFeb 13, 2015
- Feb 20, 2015Committee
Referred to the Subcommittee on Health.
Health Subcommittee - Feb 13, 2015IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee - Feb 13, 2015IntroReferralIntro-H
Introduced in House
- Feb 13, 2015IntroReferral1000
Introduced in House