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  1. Drug Safety and Availability

Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages.

In October 2019, FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions” that attempts to identify root causes and offer recommendations to help prevent and mitigate drug shortages. The recommendations were based on insights gleaned from public and private stakeholders at a November 2018 Drug Shortages Task Force Public Meeting, a docket for comments, and listening sessions with stakeholders, as well as FDA data analysis and published research.   

In February 2020, FDA recalculated both the production increase and the extent of supply restoration for drugs that were in shortage between 2013 and 2017.  To do so, we used new approaches that better capture whether each drug became more readily available during the shortage. FDA found that 42 percent of the shortage drugs had a significant production increase, meaning that new suppliers entered the market and/or existing suppliers increased their output to an extent that restored at least half of the quantity of the drug that was unavailable during the shortage.  Similarly, the Agency found that 30 percent of the shortage drugs had their quantity fully restored to pre-shortage levels.  These changes do not affect any of the Report’s conclusions or recommendations.  
 
The text that has been revised in the Report is in two sections:

  • Evidence for Root Causes, Events that Happen After Occurrence of a Shortage on pages 36 - 37; and
  • Appendix F, Key Findings, Key Finding 3 on pages 119 - 121.

Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.

Drug Shortages Database

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For Industry: Send FDA Drug Shortage and Supply Notifications

Industry can notify FDA Drug Shortage Staff via CDER Direct NextGen Portal.

This portal is intended ONLY for drug manufacturers/applicants. Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events.  If you have any questions, please contact: drugshortages@fda.hhs.gov.

FDA Drug Shortages Mobile App

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  Android App App FDA Drug Shortages App

Receive notifications when there is new or updated information about a drug product shortage or a drug within selected therapeutic categories.

 



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