H.R. 6257 (109th): Access to Life-Saving Medicine Act

Introduced:
Sep 29, 2006 (109th Congress, 2005–2006)
Status:
Died (Referred to Committee)
Sponsor
Henry Waxman
Representative for California's 30th congressional district
Party
Democrat
Text
Read Text »
Last Updated
Sep 29, 2006
Length
39 pages
Related Bills
S. 4016 (Related)
Access to Life-Saving Medicine Act

Referred to Committee
Last Action: Sep 29, 2006

 
Status

This bill was introduced on September 29, 2006, in a previous session of Congress, but was not enacted.

Progress
Introduced Sep 29, 2006
Referred to Committee Sep 29, 2006
 
Full Title

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

Summary

No summaries available.

Cosponsors
1 cosponsors (1D) (show)
Committees

House Energy and Commerce

Health

House Judiciary

House Ways and Means

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

 
Primary Source

THOMAS.gov (The Library of Congress)

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Notes

H.R. stands for 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.

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.


9/29/2006--Introduced.
Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of a comparable biological product based on its similarity to a previously licensed biological product (the reference product).
Allows a person to file an abbreviated comparable product application with the Secretary of Health and Human Services that includes:
(1) data demonstrating that the product is comparable to the reference product;
(2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the comparable 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 comparable 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. Provides market exclusivity to such an interchangeable product.
Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable product applications.
Sets forth provisions governing patent infringement claims against the license holder of a comparable product.
Amends the Internal Review Code to allow a tax credit for qualified clinical testing expenses.

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

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