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Purpose <p>Drug products play a vital role in global healthcare and are regulated in the United States by the Food and Drug Administration (FDA) to ensure their quality, safety, and efficacy. This study analyzes drug shortages regulated by the FDA’s Center for Drug Evaluation and Research (CDER) from 2019 to 2024, focusing on trends in adult and pediatric medicines. It also highlights the impact of critical events like the COVID-19 pandemic and nitrosamine-related recalls that significantly contributed to drug shortages.</p> Methods <p>Data from the FDA Drug Shortage Database were systematically analyzed and classified into adult and pediatric medicine categories. Key parameters assessed included the annual number of shortages, affected therapeutic areas, dosage forms, underlying causes, and associated manufacturers.</p> Results <p>Drug shortages increased significantly from 2019 to 2024, with adult medicines more affected than pediatric ones. Shortages were most prevalent in anesthesia, anti-infective, and cardiovascular therapies for adults, while endocrinology and anesthesia dominated pediatric shortages. Injectable dosage forms accounted for the majority of shortages, peaking at 66.4% in pediatric medicines. Primary causes of drug shortage included supply chain disruptions, manufacturing challenges, and increased demand. Pfizer Inc. was responsible for the highest number of drug shortages (8.6%), followed by Teva Pharmaceuticals USA, Inc. (6.9%) and Baxter Healthcare (5.6%).</p> Conclusion <p>Drug shortages increased significantly, with a higher number of reported cases observed in adult medicines compared to pediatric medicines. Strengthening supply chains, addressing active pharmaceutical ingredient shortages, and implementing regulatory flexibility are critical to mitigating future shortages and ensuring consistent drug availability.</p>

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Unraveling Trends in USFDAs CDER-Regulated Drug Shortages (2019–2024): Causes, Patterns, and Strategic Insights for the Future

  • 期刊论文

  • 发表日期：

    2025年6月10日

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  • V. P. Muhammad Nizam,
  • Sravani Yerram,
  • C. S. Ajmal,
  • Rajeev Singh Raghuvanshi,
  • Saurabh Srivastava

摘要

Purpose

Drug products play a vital role in global healthcare and are regulated in the United States by the Food and Drug Administration (FDA) to ensure their quality, safety, and efficacy. This study analyzes drug shortages regulated by the FDA’s Center for Drug Evaluation and Research (CDER) from 2019 to 2024, focusing on trends in adult and pediatric medicines. It also highlights the impact of critical events like the COVID-19 pandemic and nitrosamine-related recalls that significantly contributed to drug shortages.

Methods

Data from the FDA Drug Shortage Database were systematically analyzed and classified into adult and pediatric medicine categories. Key parameters assessed included the annual number of shortages, affected therapeutic areas, dosage forms, underlying causes, and associated manufacturers.

Results

Drug shortages increased significantly from 2019 to 2024, with adult medicines more affected than pediatric ones. Shortages were most prevalent in anesthesia, anti-infective, and cardiovascular therapies for adults, while endocrinology and anesthesia dominated pediatric shortages. Injectable dosage forms accounted for the majority of shortages, peaking at 66.4% in pediatric medicines. Primary causes of drug shortage included supply chain disruptions, manufacturing challenges, and increased demand. Pfizer Inc. was responsible for the highest number of drug shortages (8.6%), followed by Teva Pharmaceuticals USA, Inc. (6.9%) and Baxter Healthcare (5.6%).

Conclusion

Drug shortages increased significantly, with a higher number of reported cases observed in adult medicines compared to pediatric medicines. Strengthening supply chains, addressing active pharmaceutical ingredient shortages, and implementing regulatory flexibility are critical to mitigating future shortages and ensuring consistent drug availability.