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Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

1/11/2023, 1:28 PM

Congressional Summary of HR 971

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.

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Current Status of Bill HR 971

Bill HR 971 is currently in the status of Bill Introduced since February 13, 2015. Bill HR 971 was introduced during Congress 114 and was introduced to the House on February 13, 2015.  Bill HR 971's most recent activity was Referred to the Subcommittee on Health. as of February 20, 2015

Bipartisan Support of Bill HR 971

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
21
Democrat Cosponsors
5
Republican Cosponsors
16
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 971

Primary Policy Focus

Health

Potential Impact Areas

- Administrative law and regulatory procedures
- 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

Alternate Title(s) of Bill HR 971

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
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.
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Comments

Sponsors and Cosponsors of HR 971

Gus M. Bilirakis
Gus M. Bilirakis
FloridaRepublican
Steve Scalise
Steve Scalise
LouisianaRepublican
Christopher H. Smith
Christopher H. Smith
New JerseyRepublican
Dana Rohrabacher
Dana Rohrabacher
CaliforniaRepublican
Mike Quigley
Mike Quigley
IllinoisDemocrat
Bruce Poliquin
Bruce Poliquin
MaineRepublican

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