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S. 296 · 112th Congress

Preserving Access to Life-Saving Medications Act

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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

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.

What it does: CRS summary · Introduced in Senate · Feb 7, 2011

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Preserving Access to Life-Saving Medications Act

Latest action (Feb 7, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Policy area: Health · Origin: Senate · Introduced: Feb 7, 2011

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.