The Role of Importation in Remediating U.S. Generic Drug Shortages

Article Number: SIS018534AI210525

21st May, 2025

Author(s):

Thomas J. Bollyky, J.D.; Sarosh N. Nagar, B.A.; Chloe Searchinger, B.A.; Aaron S. Kesselheim, M.D., J.D., M.P.H

Abstract:

The ongoing shortage of generic drugs in the United States, particularly sterile injectable medicines, has led to increased reliance on temporary importation from well-regulated markets. The article examines the case of benzathine penicillin G, a critical syphilis treatment that faced supply constraints for nine months before the FDA authorized temporary importation from a European manufacturer. Drug shortages persist due to low profit margins, quality-control challenges, and prolonged FDA approval processes, often lasting three years on average. The authors argue that the FDA should streamline emergency importation policies to prevent unnecessary patient harm rather than exhausting all domestic options first.

The analysis highlights data showing that two-thirds of 81 essential generic injectables with limited U.S. manufacturers are already approved for distribution in peer-regulated countries such as Canada, Germany, and the United Kingdom. Countries like Canada and the United Kingdom have implemented expedited importation policies for essential medicines, reducing delays in responding to shortages. The authors propose that the FDA could preemptively assess foreign suppliers for essential medicines to enable quicker responses. While importation is not a long-term solution to drug shortages, it can provide resilience to U.S. supply chains until broader production reforms are enacted

Keywords:

drug shortages generic medicines FDA regulation sterile injectables pharmaceutical importation benzathine patient safety regulatory frameworks