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United States · Bill · HR

H.R. 1038 (110th)

Access to Life-Saving Medicine Act

referredUnited States· United States Congress· EN

Introduced

14 February 2007

Last action

15 February 2007 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Rep. Waxman, Henry A. [D-CA-33], Rep. Emerson, Jo Ann [R-MO-8], Rep. Pallone, Frank [D-NJ-6], Rep. Emanuel, Rahm [D-IL-5], Sen. Hirono, Mazie K. [D-HI], Rep. Stark, Fortney Pete [D-CA-13], Rep. Kilpatrick, Carolyn C. [D-MI-13], Rep. Conyers, John, Jr. [D-MI-13], Rep. Abercrombie, Neil [D-HI-1], Rep. Wamp, Zach [R-TN-3], Rep. Grijalva, Raúl M. [D-AZ-7], Rep. Pastor, Ed [D-AZ-4], Rep. Thornberry, Mac [R-TX-13], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Holden, Tim [D-PA-17], Rep. Cohen, Steve [D-TN-9], Rep. Hoekstra, Peter [R-MI-2], Rep. Woolsey, Lynn C. [D-CA-6], Rep. McCollum, Betty [D-MN-4], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Loebsack, David [D-IA-2], Rep. McCarthy, Carolyn [D-NY-4], Rep. Platts, Todd Russell [R-PA-19], Rep. Wolf, Frank R. [R-VA-10], Rep. Allen, Thomas H. [D-ME-1], Rep. Cooper, Jim [D-TN-5], Rep. Ellison, Keith [D-MN-5], Rep. Clay, Wm. Lacy [D-MO-1], Rep. Kildee, Dale E. [D-MI-5], Rep. Speier, Jackie [D-CA-14], Del. Bordallo, Madeleine Z. [D-GU-At Large], Sen. Boozman, John [R-AR], Rep. Paul, Ron [R-TX-14], Rep. Bishop, Timothy H. [D-NY-1], Rep. Rothman, Steven R. [D-NJ-9], Rep. Fattah, Chaka [D-PA-2]

Subjects

Healthcare

Source updated

5 December 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product. Sets forth conditions for approval of such an application by the Secretary. Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Provides market exclusivity to such an interchangeable product. Requires the Secretary to defer issuing a determination of interchangeability for a subsequent comparable biological product during the period of market exclusivity for a prior interchangeable comparable biological product. Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications. Sets forth provisions governing patent infringement claims against an applicant or prospective applicant for a comparable biological product license.

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

Timeline

  1. 14 February 2007

    Introduced

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Source: IntroReferral

  2. 14 February 2007

    Introduced

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Source: IntroReferral

  3. 14 February 2007

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 14 February 2007

    Introduced

    Introduced in House

    Source: IntroReferral

  5. 15 February 2007

    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 · 14 February 2007

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  • Introduced in House (PDF)

    Introduced in House · EN · 14 February 2007

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  • Introduced in House

    summary · EN · 14 February 2007

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Sponsors

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Sources

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