S.296 - Preserving Access to Life-Saving Medications Act

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. view all titles (2)

All Bill Titles

  • Official: 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. as introduced.
  • Short: Preserving Access to Life-Saving Medications Act as introduced.

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Bill’s Views

  • Today: 2
  • Past Seven Days: 10
  • All-Time: 4,957
 
Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
02/07/11
 
 
 
 
 
 
 

Sponsor

Senator

Amy Klobuchar

D-MN

View Co-Sponsors (30)

Official Summary

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 tha

Official Summary

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.

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Organizations Supporting S.296

  • American Society of Hematology
  • American Society of Health System Pharmacists
  • American College of Clinical Pharmacy
  • American Hospital Association
  • American Society for Parenteral and Enteral Nutrition
  • Leukemia and Lymphoma Society
  • ...and 8 more. See all.

Organizations Opposing S.296

  • None via MapLight at this time.


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