# Generic oncology drug supply and shortage mitigation

Source: https://onco.cc/technologies/generic-drug-shortage-response/  
OnCo record `generic-drug-shortage-response` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-09-08
- Tags: supporting
- 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

## Sources

- FDA: drug shortages: https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

## Connected records

- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [BCG manufacturing and the bladder cancer BCG shortage](https://onco.cc/technologies/bcg-vaccine-manufacturing/), [Closed-system transfer devices for hazardous drugs (PhaSeal, ChemoLock, Equashield)](https://onco.cc/technologies/closed-system-transfer-devices/), [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Generic sterile injectables (the 2023 platinum shortage)](https://onco.cc/technologies/sterile-injectable-generics-manufacturing/), [GMP, inspections, Form 483s and warning letters](https://onco.cc/technologies/pharmaceutical-gmp-inspections/), [Platinum agents](https://onco.cc/technologies/platinum/), [Small-molecule API synthesis](https://onco.cc/technologies/small-molecule-api-synthesis/), [Sterile fill-finish and lyophilisation](https://onco.cc/technologies/sterile-fill-finish/)
- companies: [Amneal Pharmaceuticals](https://onco.cc/companies/amneal/), [Civica Rx](https://onco.cc/companies/civica-rx/), [Fresenius Kabi](https://onco.cc/companies/fresenius-kabi/), [Hikma Pharmaceuticals](https://onco.cc/companies/hikma/)
- terms: [Hatch-Waxman Act 1984](https://onco.cc/terms/hatch-waxman/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/), [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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