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H.R. 1223 · 115th Congress

OPEN Act

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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act

What it does: CRS summary · Introduced in House · Feb 27, 2017

Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department 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).

HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.

HHS must notify the public of products that receive this extension and patents related to those products.

Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions.

The bill applies only to products approved after enactment of this bill 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: OPEN Act

Also known as: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017

Latest action (Mar 3, 2017): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Feb 27, 2017

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.