Access to Life-Saving Medicine Act

A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.

2/15/2007--Introduced.
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.

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Sponsor

• Sen. Charles Schumer [D, NY]
• and 7 Co-Sponsors
  • Sen. Sherrod Brown [D, OH]
  • Sen. Hillary Clinton [D, NY]
  • Norm Coleman
  • Sen. Susan Collins [R, ME]
  • Sen. Patrick Leahy [D, VT]
  • Sen. Debbie Ann Stabenow [D, MI]
  • Sen. David Vitter [R, LA]
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Committees

• Senate Health, Education, Labor, and Pensions

Amendments

This bill has no amendments.

Amendments to S.623

Number	Status	Purpose

Bill Status

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Introduced		Voted on by Senate		Voted on by House		Considered By President		Bill Becomes Law
February 15, 2007

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All Bill Actions

• Feb 27, 2007: Star Print ordered on S. 623.
• Feb 15, 2007: Introductory remarks on measure. (CR S2053-2054)
• Introduced on Feb 15, 2007.
• Feb 15, 2007: Sponsor introductory remarks on measure. (CR S2053-2054)
• Feb 15, 2007: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Related Bills:

• H.R.1038

Related Issue Areas:

• Medicine
• Actions and defenses
• Administrative remedies
• Business
• 21 more
• Clinical trials
• Congressional reporting requirements
• Consumers
• Department of Health and Human Services
• Drug approvals
• Drug industry
• Executive departments
• Food and Drug Administration (FDA)
• Injunctions
• Intellectual property
• Judicial opinions
• Judicial review
• Labeling
• Law
• Licenses
• Medical care
• Patent infringement
• Patents
• Pharmaceutical research
• Product safety
• Science policy

Data from the Congressional Research Service

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In the News

July 03, 2007 Support bill to help lower drug prices

I support the Access to Life-Saving Medicine Act (S. 623, HR 1038) that would provide this statutory pathway and help make critical medicines more available ...

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Source: Toledo Blade, OH

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June 21, 2007 Medco CEO Lays Out Generic Industry Action Plan

It is “mandatory” that Congress pass legislation to create a pathway for follow-on biologics, and the Access to Life-Saving Medicine Act, S. 623 and HR 1038 ...

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Source: FDA news (subscription), VA

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March 08, 2007 AARP Urges Congress to Pave Way for Generic Biologics

S. 623 and HR 1038 would direct the FDA to establish a process for bringing these treatments to market. It would ensure that Americans have improved access ...

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Source: PR Newswire (press release), NY

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Blog Coverage

January 04, 2009 Patent Docs: Top Stories of 2008: #9 to #6

... exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data exclusivity and eight years of market exclusivity), and S. 623 and H.R. 1038 (which do not address data/market exclusivity). ...

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Source: Patent Docs

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November 18, 2008 DIE LINKE: Pogrom 1938

... Deutschen zum Wort Johann Gottlieb Fichtes von der ‚Gleichheit alles dessen, was Menschenantlitz trägt’." Der gelbe Fleck. Von Rudolf Hirsch und Rosemarie Schuder, Verlag Rütten & Loening Berlin 1987, 1. Auflage 1989, S. 623-62

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November 18, 2008 DIE LINKE: Pogrom 1938

... Deutschen zum Wort Johann Gottlieb Fichtes von der ‚Gleichheit alles dessen, was Menschenantlitz trägt’." Der gelbe Fleck. Von Rudolf Hirsch und Rosemarie Schuder, Verlag Rütten & Loening Berlin 1987, 1. Auflage 1989, S. 623-62

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Source: DIE LINKE.

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