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U.S. Department of Health and Human Services

About FDA

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A Review of FDA's Approach to Medical Product Shortages

Drug and other medical product shortages have the potential to adversely affect patient care by delaying treatment or forcing the use of second-choice products. Some recent shortages have involved drugs for life-threatening conditions and, in some cases, the product in shortage has been the only product for the patient’s condition. This is a significant public health problem, one that deserves the concerted attention of government and industry.

The Food and Drug Administration (FDA) conducted a review of medical product shortage activities in four medical product Centers in the FDA and talked to external stakeholders in the drug arena to understand their perspectives on the problem. This report is based on these conversations, a review of published and unpublished information on drug shortages, and analyses of databases either already available or created for this report.

This report has identified a number of respects in which FDA’s internal processes might be improved, so that FDA is maximizing its contribution to the prevention and mitigation of shortages.

A Review of FDA

Printer-friendly PDF (473KB)

Immediate Actions:

  • Write a letter to drug manufacturers reminding them of their current legal obligations to notify FDA in advance of the discontinuation of certain drugs and urging them to voluntarily notify FDA of other potential disruptions to the supply of drugs that are not currently required, as soon as they become aware of them
  • Develop guidance and regulations that clarify and enhance the information on potential drug shortages that is submitted by industry
  • Provide additional staffing resources for FDA’s efforts to prevent and mitigate shortages
  • Support legislation that requires early notification by manufacturers for drug shortages and provides new authority to FDA to enforce these requirements
  • Implement and maintain a database that can analyze the characteristics of drug shortages