GovTrack’s Bill Summary
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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)
- Status:
- Died (Referred to Committee) in a previous session of Congress
Status
This bill was introduced on February 14, 2007, in a previous session of Congress, but was not enacted.
Introduced
Feb 14, 2007
About the bill
- Sponsor
- Henry Waxman
Representative for California's 30th congressional district
- Party
- Democrat
- Text
- Read Text »
- Last Updated
- Feb 14, 2007
- Length
- 38 pages
S. 623
(identical)
Referred to Committee
Last Action: Feb 15, 2007
- Summary
-
No summaries available.
Details
- Cosponsors
-
35 cosponsors (27D, 8R) (show)
- Committee Assignments
-
↪ Health
The committee chair determines whether a bill will move past the committee stage.
- Votes
-
There have been no votes related to this bill.
Notes, links & tools
- Notes
-
The “H.R.” in H.R. 1038 means this is a House of Representatives bill.
A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.
The bill’s title was written by its sponsor.
- Primary Source
-
THOMAS.gov (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. Data comes via the congress project.
- Widget
- Citation
-
Click a format for a citation suggestion:
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 Democratic Caucus Summary
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