In this episode of The Pharma Perspective podcast, Jerry Avorn, Professor of Medicine at Harvard Medical School and author of "Rethinking Medications," discusses the state of drug regulation in the United States, the problems with accelerated approvals and missing confirmatory trials, how academic detailing can change prescribing behavior more effectively than guidelines, the misuse of surrogate endpoints in drug development, why weak FDA enforcement actually harms pharmaceutical innovation, the absence of cost-effectiveness analysis and health technology assessment in US drug policy, and where he sees hope for reform through state-level drug policy coalitions and evidence-based prescribing initiatives.

In this episode of The Pharma Perspective podcast, Katja Rüdell, one of the world's leading clinical outcome assessment and patient-reported outcomes experts, discusses the role of PROs in drug development, regulatory expectations from FDA and EMA for outcome measure validation, the challenges of developing fit-for-purpose COA instruments, the evolution of patient-centred research in pharmaceutical clinical trials, and best practices for ensuring PRO data meets both regulatory and clinical standards.

In this episode of The Pharma Perspective podcast, Jack Neill-Hall from the Association of the British Pharmaceutical Industry (ABPI) discusses the UK pharmaceutical pricing environment, NICE's cost-effectiveness threshold and appraisal process for NHS medicines, industry transparency through the Code of Practice and Disclosure UK, healthcare budget allocation, and why some medicines never reach UK assessment.