Opaque generic approvals endanger patients

Investigative evidence that a generic version of tacrolimus may have contributed to transplant patient deaths shows how current bioequivalence standards, manufacturing oversight and postmarket surveillance can fail for narrow‑therapeutic‑index drugs. The gap spans regulators (FDA), manufacturers, hospital pharmacists, and prescribing practices and creates preventable fatality risk when substitutions are allowed without rigorous batch‑level verification and clinical follow‑up. — This forces immediate policy choices on tightening generic approval standards, mandatory postmarket therapeutic monitoring for narrow‑index drugs, pharmacy substitution rules, and transparent reporting systems to catch harmful batches early.