Reducing Prescription Drug Shortages

2011-11-03Executive Order 13588
Signed by: Barack Obama
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Headline: Requires Food and Drug Administration Action to Prevent Drug Shortages

What it does: The Food and Drug Administration must require advance notice of possible drug manufacturing stoppages, speed regulatory reviews to prevent shortages, and report hoarding or price-gouging to the Justice Department.

Real World Impact:
  • Endangers patient safety and disrupts treatment for serious illnesses
  • Creates extra burdens for doctors, hospitals, pharmacists, and patients
  • Can lead to hoarding or exorbitant prices, raising healthcare costs
Topics: drug shortages, public health, healthcare costs, drug manufacturing, consumer protection

Summary

This order directs the Food and Drug Administration to take steps to prevent and reduce shortages of prescription medicines that are life-supporting, life-sustaining, or prevent serious disease. It tells the agency to require earlier notice when manufacturers plan to stop or change production, speed reviews of new suppliers and manufacturing changes, and report suspected hoarding or price-gouging to the Justice Department.

Patients, doctors, hospitals, pharmacists, and drug manufacturers are affected. The goal is to protect patient safety, reduce treatment disruptions, and limit higher health care costs.

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