Barbara McAneny, Rafael Fonseca, and Steve Potts: Protecting Patients Amid the IRA

In this episode of the Vital Health Podcast, host Duane Schulthess convenes three leading voices from the 2025 BIO International Convention - prominent physicians, innovators, and advocates shaping the future of drug development in the wake of the Inflation Reduction Act (IRA). Throughout this conversation, they examine policy impacts, clinical ramifications, and patient access challenges:

• Barbara McAneny: Former American Medical Association President; Co‑Chair, ONCare Alliance; CEO, New Mexico Oncology Hematology Consultants, Ltd.
• Rafael Fonseca: Chief Innovation Officer & Getz Family Professor of Cancer, Mayo Clinic in Arizona
• Steve Potts: Chair, Drug Development Council, ICAN (International Cancer Advocacy Network)

Key Topics:

• Pipeline Modality Shifts: Early‑stage developers are retooling small molecule programs into biologics, or abandoning follow‑on indications altogether to sidestep the IRA’s nine‑year exclusivity pill penalty.
• Clinical Trial Ecosystem: Independent and academic centers alike are seeing fewer small molecule trials, threatening orphan drug expansions and revenue streams that underwrite care.
• Oncology Practice Economics: Cuts to drug margins will jeopardize community practices, forcing difficult choices between patient treatment and financial survival.
• Patient Affordability & Copays: The cap on out‑of‑pocket oral drug costs versus the hidden burden of high copays and co‑insurance - and why eliminating them could raise premiums only modestly.
• PBM & Insurer Vertical Integration: Payers acquiring manufacturers and ownership of formularies are steering patients toward the highest‑rebate products at the expense of clinical judgment.
• Broader Systemic Ripples: From congested ERs due to unmanaged side effects to rural access collapse, plus the missed opportunity to cut PBM take‑rates instead of hampering innovation.
• Policy Fix Imperatives: Proposals include recalibrating exclusivity durations (extend small molecule to 13 years), automating rebate flows to CMS, and overhauling PBM incentives.

This discussion covers the interplay between drug-pricing reform and the future of care, highlighting unintended consequences and pragmatic solutions. It’s essential listening for policymakers, payers, industry leaders, patient advocates, and every stakeholder invested in sustaining medical innovation and ensuring equitable patient access.

Opinions expressed are those of the speakers, not the companies listed. Recorded on June 16, 2025.

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