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Generic Chemotherapy Shortages Force Hospitals to Change Dosing

Regulators are weighing temporary importation after contamination at a German contract facility sharply reduced production, leaving hospitals to change doses, prioritize patients

Overview

  • Multiple older generic chemotherapy drugs including ifosfamide, cisplatin, carboplatin and oxaliplatin are in short supply, forcing clinics to alter treatment schedules and conserve stock.
  • Group-purchasing data shows severe order shortfalls, with roughly 38% of ifosfamide requests filled and about two-thirds of cisplatin orders met, restricting routine access for many patients.
  • The ifosfamide gap traces to repeated microbial contamination found at Simtra BioPharma Solutions’ German contract plant, an FDA inspection that led to a March warning letter, and an EMA estimate that full output may not resume until early 2027.
  • Clinicians report they are spacing doses, scheduling patients consecutively to avoid waste, and prioritizing those judged most likely to benefit from limited supplies, which is creating agonizing treatment decisions for families and care teams.
  • U.S. regulators and HHS say they are working with manufacturers and may use temporary importation to bridge shortages, a step previously used in 2023, while the situation highlights risks from concentrated production and platinum price pressures.