H.R. 1038 (110th): To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes.

Introduced:
Feb 14, 2007 (110th Congress, 2007–2009)
Sponsor:
Rep. Henry Waxman [D-CA30]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

(About Ads | Go Ad-Free for $5)
Status

This bill was introduced on February 14, 2007, in a previous session of Congress, but was not enacted.

Progress
Introduced Feb 14, 2007
Cosponsors
35 cosponsors (27D, 8R) (show)
Committees

House Energy and Commerce

House Judiciary

The committee chair determines whether a bill will move past the committee stage.

Summary

No summaries available.

Text

Read Bill Text »

Last updated Feb 14, 2007.
38 pages

Primary Source

View on THOMAS (The Library of Congress)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here.

Citation

Click a format for a citation suggestion:

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

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.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

The House Democratic Caucus does not provide summaries of bills.

So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.

We’ll be looking for a source of summaries from the other side in the meanwhile.

The bill contains the following citations to other parts of U.S. law:

United States Code

The United States Code is the compilation of permanent laws enacted by Congress. Temporary and other non-permanent laws do not appear in the United States Code. (About half of the United States Code is the law itself, called positive law. The other half is merely a compilation of the laws but has no legal significance.)

  • Title 21: FOOD AND DRUGS
  • Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT
  • Subchapter VII: GENERAL AUTHORITY
  • Part C: Fees
  • Subpart 2: fees relating to drugs
  • Section 379g: Definitions
  • Title 28: JUDICIARY AND JUDICIAL PROCEDURE
  • Part VI: PARTICULAR PROCEEDINGS
  • Chapter 151: DECLARATORY JUDGMENTS
  • Section 2201: Creation of remedy
  • Title 35: PATENTS
  • Part III: PATENTS AND PROTECTION OF PATENT RIGHTS
  • Chapter 28: INFRINGEMENT OF PATENTS
  • Section 271: Infringement of patent
  • Title 42: THE PUBLIC HEALTH AND WELFARE
  • Chapter 6A: PUBLIC HEALTH SERVICE
  • Subchapter II: GENERAL POWERS AND DUTIES
  • Part F: Licensing of Biological Products and Clinical Laboratories
  • Subpart 1: biological products
  • Section 262: Regulation of biological products

Other Citations

  • 28 U.S.C. Chapter 87