Can the US–India Partnership Fix Cancer Drug Shortages? | Kathleen Jaeger

Описание: In this episode on OncoDaily TV, host Amalya Sargsyan, MD (VP, Research & Intelligence) speaks with Kathleen Jaeger, U.S. Spokeswoman for the Indian Pharmaceutical Alliance, about how U.S.–India (and Europe) collaboration on high-quality generics can strengthen oncology supply, reduce costs, and de-risk dependence on single-country sources for KSMs/APIs - while keeping FDA-level quality front and center.

Key points
✅ Access & affordability: Generics make up ~90% of U.S. prescriptions and are typically ~80% cheaper, unlocking care for more patients.
✅ Global supply reality: India supplies ~50–60% of U.S. generics; chokepoints sit upstream in KSMs/APIs.
✅ De-risking from China: Policy focus is shifting to diversify sources for critical oncology inputs to prevent shortages.
✅ Quality first: FDA quality maturity metrics, unannounced inspections, and digital/AI oversight.
✅ Why shortages happen: Root causes
✅ Policy tools: Defense Production Act Title III, the U.S.–India “Trust” framework, and an Affordable Medicines Partnership.
✅ Clinician perspective: If FDA-approved and guideline-endorsed, generics/biosimilars offer the same safety/efficacy as brands.
✅ Health security: “Medicine security = national security”—resilient oncology supply chains are a public-interest imperative.

0:00 Introduction
2:10 Generics 101—access, affordability, impact
3:42 U.S. savings & utilization
4:20 COVID lessons: KSM/API dependence & India’s response
8:17 Quality safeguards & “lighthouse” facilities
11:26 Policy levers: DPA Title III, reshoring critical inputs
12:58 U.S.–India “Trust” framework → Affordable Medicines Partnership
15:19 Root causes of shortages
18:44 Clinician view: trust, guidelines, biosimilars
24:23 Tariffs vs incentives—what actually builds resiliency
26:30 What’s next: trade agreement, implementation, diversification
27:40 Health/medicine security as national security
30:05 Closing

#Oncology #Generics #Biosimilars #DrugShortages #SupplyChain #APIs #KSMs #USIndia #FDA #Quality #CancerPolicy #Access #Affordability #OncoDaily

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