{"entity":{"id":"generic-drug-shortage-response","kind":"technology","name":"Generic oncology drug supply and shortage mitigation","aka":[],"tldr":"Keeping cheap, essential chemotherapy drugs like cisplatin available; shortages in 2023 forced rationing in US hospitals.","summary":"Sterile injectable generics (platinums, 5-FU, methotrexate) have thin margins and few manufacturers; the 2023 cisplatin/carboplatin shortage followed an FDA import alert on Intas. Responses: temporary imports (Qilu), Civica Rx and Phlow non-profit manufacturing, the White House/HHS supply-chain resilience programme, and FDA's Drug Shortage Task Force. Europe's Critical Medicines Act (2025) targets similar risks.","status":"established","asOf":"2026-09-08","links":[{"label":"FDA: drug shortages","url":"https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["chemotherapy","supportive-care"],"technologies":["sterile-fill-finish","platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["civica-rx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"principle":"Redundant qualified sources, strategic reserves, and pricing floors to keep low-margin essential drugs in production.","strengths":["Policy attention since 2023"],"limitations":["Economics still unfavourable","Quality problems at concentrated sites recur"]},"route":"/technologies/generic-drug-shortage-response/","neighbours":{"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"bcg-vaccine-manufacturing","kind":"technology","name":"BCG manufacturing and the bladder cancer BCG shortage","route":"/technologies/bcg-vaccine-manufacturing/"},{"id":"closed-system-transfer-devices","kind":"technology","name":"Closed-system transfer devices for hazardous drugs (PhaSeal, ChemoLock, Equashield)","route":"/technologies/closed-system-transfer-devices/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"sterile-injectable-generics-manufacturing","kind":"technology","name":"Generic sterile injectables (the 2023 platinum shortage)","route":"/technologies/sterile-injectable-generics-manufacturing/"},{"id":"pharmaceutical-gmp-inspections","kind":"technology","name":"GMP, inspections, Form 483s and warning letters","route":"/technologies/pharmaceutical-gmp-inspections/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"small-molecule-api-synthesis","kind":"technology","name":"Small-molecule API synthesis","route":"/technologies/small-molecule-api-synthesis/"},{"id":"sterile-fill-finish","kind":"technology","name":"Sterile fill-finish and lyophilisation","route":"/technologies/sterile-fill-finish/"}],"company":[{"id":"amneal","kind":"company","name":"Amneal Pharmaceuticals","route":"/companies/amneal/"},{"id":"civica-rx","kind":"company","name":"Civica Rx","route":"/companies/civica-rx/"},{"id":"fresenius-kabi","kind":"company","name":"Fresenius Kabi","route":"/companies/fresenius-kabi/"},{"id":"hikma","kind":"company","name":"Hikma Pharmaceuticals","route":"/companies/hikma/"}],"term":[{"id":"hatch-waxman","kind":"term","name":"Hatch-Waxman Act 1984","route":"/terms/hatch-waxman/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}