S. 296 (112th): Preserving Access to Life-Saving Medications Act

Introduced:
Feb 07, 2011 (112th Congress, 2011–2013)
Sponsor:
Sen. Amy Klobuchar [D-MN]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on February 7, 2011, in a previous session of Congress, but was not enacted.

Progress
Introduced Feb 07, 2011
Referred to Committee Feb 07, 2011
Cosponsors
30 cosponsors (28D, 1I, 1R) (show)
Committees

Senate Health, Education, Labor, and Pensions

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

Full Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages.

Summary

No summaries available.

Text

Read Bill Text »

Last updated Feb 07, 2011.
7 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

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

2/7/2011--Introduced.
Preserving Access to Life-Saving Medications Act - Amends the Federal Food, Drug, and Cosmetic Act to require a prescription drug manufacturer to notify the Secretary of Health and Human Services (HHS) of a discontinuance, interruption, or other adjustment of the manufacture of the drug that would likely result in a shortage of such drug.
Requires:
(1) six months notice of any discontinuance or planned interruption or adjustment, and
(2) notice as soon as practicable after becoming aware of such interruption or adjustment in the case of any other interruption or adjustment.
Applies this Act to any approved prescription drug that is not a product that was originally derived from human tissue and was replaced by a recombinant product.
Sets forth the types of adjustment for which a manufacturer must submit notice, including:
(1) adjustments related to the supply of raw materials,
(2) adjustments to production capabilities,
(3) business decisions that may affect the manufacture of the drug, and
(4) other adjustments as determined appropriate by the Secretary.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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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.)