S.296 - Preserving Access to Life-Saving Medications Act112th Congress (2011-2012)
|Sponsor:||Sen. Klobuchar, Amy [D-MN] (Introduced 02/07/2011)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 02/07/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Summary: S.296 — 112th Congress (2011-2012)All Information (Except Text)
Introduced in Senate (02/07/2011)
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.