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United States · Bill · HR

H.R. 1223 (115th)

OPEN Act

referredUnited States· United States Congress· EN

Introduced

27 February 2017

Last action

3 March 2017 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Rep. Bilirakis, Gus M. [R-FL-12], Rep. Butterfield, G. K. [D-NC-1], Rep. McCaul, Michael T. [R-TX-10], Rep. Lance, Leonard [R-NJ-7], Rep. Frelinghuysen, Rodney P. [R-NJ-11], Rep. Soto, Darren [D-FL-9], Rep. Murphy, Tim [R-PA-18], Rep. Eshoo, Anna G. [D-CA-18], Rep. Donovan, Daniel M., Jr. [R-NY-11], Sen. Mullin, Markwayne [R-OK], Rep. Norcross, Donald [D-NJ-1], Rep. Fortenberry, Jeff [R-NE-1], Rep. Huffman, Jared [D-CA-2], Rep. Bacon, Don [R-NE-2], Rep. Webster, Daniel [R-FL-11], Rep. Palazzo, Steven M. [R-MS-4], Rep. Rooney, Francis [R-FL-19], Rep. Lofgren, Zoe [D-CA-18], Rep. McMorris Rodgers, Cathy [R-WA-5], Rep. Sires, Albio [D-NJ-13], Rep. Swalwell, Eric [D-CA-15], Rep. Upton, Fred [R-MI-6], Rep. Olson, Pete [R-TX-22], Rep. Long, Billy [R-MO-7], Rep. Shea-Porter, Carol [D-NH-1], Rep. Brooks, Mo [R-AL-5], Rep. Stivers, Steve [R-OH-15], Rep. Clay, Wm. Lacy [D-MO-1], Rep. Comstock, Barbara [R-VA-10], Rep. Smith, Christopher H. [R-NJ-4], Rep. Hastings, Alcee L. [D-FL-20], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Lujan Grisham, Michelle [D-NM-1], Rep. Young, David [R-IA-3], Rep. Culberson, John Abney [R-TX-7], Rep. Rice, Kathleen M. [D-NY-4], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Visclosky, Peter J. [D-IN-1], Rep. Reichert, David G. [R-WA-8], Rep. Posey, Bill [R-FL-8], Rep. Messer, Luke [R-IN-6], Rep. Roskam, Peter J. [R-IL-6], Rep. Poe, Ted [R-TX-2], Rep. Price, David E. [D-NC-4]

Subjects

Healthcare

Source updated

11 August 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 27 February 2017

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 27 February 2017

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 27 February 2017

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 3 March 2017

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 27 February 2017

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  • Introduced in House (PDF)

    Introduced in House · EN · 27 February 2017

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  • Introduced in House

    summary · EN · 27 February 2017

    Open at official source

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Sponsors

Related records

Sources

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