HR 1223 115th Congress House Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government information and archives Intellectual property Prescription drugs

OPEN Act

Introduced: March 8, 2017 Introduced by: Bilirakis, Gus M. Republican · Florida See on congress.gov

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Mar 3, 2017

Referred to the Subcommittee on Health.

Feb 27, 2017

Referred to the House Committee on Energy and Commerce.

Feb 27, 2017

Introduced in House

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Plain-English summary Congressional Research Service

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.

What's happening now March 3, 2017

Referred to the Subcommittee on Health.

Related & companion bills 1

Bill text 1 version