Importation in Remediating U.S. Generic Drug Shortages

This article discusses how temporary importation of generic medicines from well-regulated international markets can help address persistent U.S. drug shortages especially for sterile injectables with limited domestic manufacturing. The authors argue that while the FDA has authorized such importation over 20 times since 2017, delays in action often prolong patient risk and system strain. Using recent shortages of benzathine penicillin G and fludarabine as examples, the piece recommends proactive identification of alternative foreign sources and improved readiness to authorize imports. Lessons from peer nations like Canada and the U.K. are highlighted to illustrate how streamlined importation processes can strengthen supply-chain resilience without undermining U.S. regulation.

This article discusses how temporary importation of generic medicines from well-regulated international markets can help address persistent U.S. drug shortages especially for sterile injectables with limited domestic manufacturing. The authors argue that while the FDA has authorized such importation over 20 times since 2017, delays in action often prolong patient risk and system strain. Using recent shortages of benzathine penicillin G and fludarabine as examples, the piece recommends proactive identification of alternative foreign sources and improved readiness to authorize imports. Lessons from peer nations like Canada and the U.K. are highlighted to illustrate how streamlined importation processes can strengthen supply-chain resilience without undermining U.S. regulation.