National Impact: Strengthening U.S. Medicine Supply Resilience.

By: Flavio Nascimento

Drug shortages constitute a persistent, systemic, and nationally significant public health challenge in the United States. Federal agencies and independent scientific organizations have consistently recognized that disruptions in the pharmaceutical supply chain directly compromise patient safety, continuity of care, and the operational stability of healthcare systems nationwide [1].

Beyond molecule-level reporting, recent federal analysis demonstrates that the true operational impact of shortages is substantially larger when assessed at the product level. Between 2018 and 2023, 258 drug molecules in shortage corresponded to 1,961 affected prescription products (9-digit NDCs) regulated by the FDA’s Center for Drug Evaluation and Research (CDER), illustrating how a single shortage event can cascade across multiple manufacturers, dosage forms, and presentations [1].

According to the U.S. Pharmacopeia (USP) Annual Drug Shortages Report, long-standing drug shortages continue to dominate the U.S. pharmaceutical landscape. Although the total number of new shortages declined in 2024, 98 active drug shortages remained, with 89% persisting from prior years. Critically, the average duration of an active drug shortage now exceeds four years, and more than 40 essential medicines have been in shortage for three years or longer, including several life-saving injectable drugs used in oncology, emergency medicine, and pediatric care [2].

Federal data further confirm that injectable medicines are disproportionately affected. While oral solid dosage forms dominate overall drug utilization, injectables accounted for approximately 50% of all shortages between 2018 and 2023, with a median shortage duration of 4.6 years, compared to 1.6 years for oral products. Essential medicines, as defined by federal criteria, exhibit longer median shortage durations (4.04 years) than non-essential products, underscoring the direct impact on critical care delivery [1].

These findings confirm that drug shortages are no longer episodic market disruptions, but rather structural failures of the pharmaceutical supply chain. The USP identifies four interrelated root causes driving shortages:

(1) low-price, low-margin economic dynamics;

(2) high manufacturing complexity, particularly for sterile injectables;

(3) geographic concentration of production creating single points of failure; and

(4) deficiencies in quality management maturity and regulatory compliance.

Once a medicine enters shortage, resolution is typically slow, reflecting limited surge capacity, constrained redundancy, and insufficient system-wide resilience [1][2].

The U.S. Food and Drug Administration (FDA) similarly recognizes drug shortages as a top national priority. In its 2024 annual analysis, the FDA reported 113 active drug shortages, affecting a broad range of therapeutic classes and disease states. While the agency successfully prevented or mitigated 283 potential shortages through extraordinary regulatory interventions—including temporary importation, accelerated inspections, and enforcement discretion—these measures are acknowledged as reactive and unsustainable substitutes for long-term structural solutions [3].

Both the FDA and USP emphasize that the most vulnerable segment of the supply chain involves sterile injectable medicines, which require complex manufacturing processes, stringent quality controls, and highly reliable logistics, including temperature-controlled distribution. Manufacturing sites associated with drugs in shortage demonstrate a higher incidence of adverse inspection outcomes, reinforcing the link between quality management maturity, operational execution, and national drug availability [1][2][3].

Perfecta Consultancy exists to address these root causes with practical, compliance-ready solutions—combining pharmaceutical logistics expertise, regulatory alignment, and data-driven risk intelligence to help organizations build reliable, resilient, and accountable medicine supply operations. By focusing on the structural and operational drivers of shortages, Perfecta supports national efforts to reduce shortage duration, mitigate supply disruption risk, and protect patient access to essential therapies.

References

1. HHS/ASPE Office of Science and Data Policy. Analysis of Drug Shortages, 2018–2023. J. Daniel McGeeney, Emily McAden, and Aylin Sertkaya. January 2025.

2. U.S. Pharmacopeia (USP). USP Annual Drug Shortages Report: Long-standing drug shortages persist in 2024. May 2025.

3. U.S. Food and Drug Administration (FDA). Drug Shortages: Annual Report, Calendar Year 2024.