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Titles (2)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

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.


Actions Overview (1)

Date
02/13/2015Introduced in House

All Actions (3)

Date
02/20/2015Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
02/13/2015Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
02/13/2015Introduced in House
Action By: House of Representatives

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce02/13/2015 Referred to
House Energy and Commerce Subcommittee on Health02/20/2015 Referred to

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Latest Summary (1)

There is one summary for H.R.971. View summaries

Shown Here:
Introduced in House (02/13/2015)

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.