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

2/14/2007--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.

... morehide bill summary

Sponsor

• Rep. Henry Waxman [D, CA-30]
• and 35 Co-Sponsors
  • Rep. Neil Abercrombie [D, HI-1]
  • Thomas Allen
  • Rep. Timothy Bishop [D, NY-1]
  • Rep. John Boozman [R, AR-3]
  • Rep. Madeleine Bordallo [D, GU-0]
  • Rep. William Clay [D, MO-1]
  • Rep. Steve Cohen [D, TN-9]
  • Rep. John Conyers [D, MI-14]
  • Rep. Jim Cooper [D, TN-5]
  • Rep. Keith Ellison [D, MN-5]
  • Rep. Rahm Emanuel [D, IL-5]
  • Rep. Jo Ann Emerson [R, MO-8]
  • Rep. Chaka Fattah [D, PA-2]
  • Rep. Raul Grijalva [D, AZ-7]
  • Rep. Mazie Hirono [D, HI-2]
  • Rep. Peter Hoekstra [R, MI-2]
  • Rep. Tim Holden [D, PA-17]
  • Rep. Dale Kildee [D, MI-5]
  • Rep. Carolyn Kilpatrick [D, MI-13]
  • Rep. David Loebsack [D, IA-2]
  • Rep. Carolyn McCarthy [D, NY-4]
  • Rep. Betty McCollum [D, MN-4]
  • Rep. Eleanor Norton [D, DC-0]
  • Rep. Frank Pallone [D, NJ-6]
  • Rep. Edward Pastor [D, AZ-4]
  • Rep. Ronald Paul [R, TX-14]
  • Rep. Todd Platts [R, PA-19]
  • Rep. Steven Rothman [D, NJ-9]
  • Rep. Louise Slaughter [D, NY-28]
  • Rep. Jackie Speier [D, CA-12]
  • Rep. Fortney Stark [D, CA-13]
  • Rep. William Thornberry [R, TX-13]
  • Rep. Zach Wamp [R, TN-3]
  • Rep. Frank Wolf [R, VA-10]
  • Rep. Lynn Woolsey [D, CA-6]
  close

Committees

• House Judiciary
• 2 more
  • House Energy and Commerce
  • House Energy and Commerce
  close

Amendments

This bill has no amendments.

Amendments to H.R.1038

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
February 14, 2007

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All Bill Actions

• Feb 15, 2007: Referred to the Subcommittee on Health.
• Feb 14, 2007: Referred to House Energy and Commerce
• Feb 14, 2007: 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.
• Introduced on Feb 14, 2007.
• Feb 14, 2007: Referred to House Judiciary

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Related Bills:

• S.623

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

March 07, 2007 Senate To Hear About Biogenerics

In summary, HR 1038 would amend section 351 of the Public Health Service (PHS) Act to authorize the Secretary of HHS to approve abbreviated applications for ...

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Source: Patent Baristas, OH

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February 16, 2007 Bill Re-Introduced to Create Path for Biogenerics

Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced HR 1038, the “Access to Life-Saving Medicine Act,” ...

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Blog Coverage

January 05, 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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December 31, 2008 Eye on FDA: Welcome 2009 - What's in Store for the Pharmaceutical ...

H.R. 1038 - `Access to Life-Saving Medicine Act' · H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study ...

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December 29, 2008 Eye on FDA: New Prostate Cancer Treatment Approved by FDA

H.R. 1038 - `Access to Life-Saving Medicine Act' · H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 · H.R. 3 - Stem Cell Research Enhancement Act of 2007 · H.R. 331 - Drug Expiration Date Study ...

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Source: Eye on FDA

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