Ep 30 | ACNU Live Panels Follow-Up: Deep Dive Virtual Panel On FDA’s New ACNU Rule

In this episode of the Only Healthcare Podcast, co-host Randy Vogenberg, PhD moves beyond the Nicholas Hall North America Conference to break down the FDA’s new Additional Conditions for Nonprescription. Guests Mary Alice Lawless, Ted Lawless, and Chelsea Ryan explain how ACNU grew from long-standing FDA concern over chronic undertreatment in conditions like hypertension, high cholesterol, asthma, and migraine, leading to the rule’s launch in May 2025.

Mary Alice outlines the public health need behind ACNU, showing how nonadherence drives avoidable hospitalizations, higher costs, and an estimated 125,000 preventable deaths each year. She explains why the FDA sees digitally supported nonprescription access as a safe way to expand treatment. Ted covers the financial implications, from algorithm-based tools that reduce development risk to the long-term value of direct consumer relationships.

Chelsea brings the retail view, describing why brick and mortar remains central even as consumers expect blended digital and in-store steps like ID checks and guided prompts. The conversation also explores equity, the limits of simple questionnaires, and how ACNU programs can use existing health data infrastructure to support lower-literacy and multilingual populations.

Key Topics
• Why ACNU was created to address undertreatment and access barriers.
• The public health toll of nonadherence and preventable hospitalizations.
• How ACNU differs from traditional OTC switches through added safety steps.
• The role of algorithm-driven digital pathways to verify safe use.
• How sponsors can forecast investment, timelines, and long-term value.
• Where ACNU fits in retail and omnichannel journeys.
• Consumer attitudes toward nonprescription access and required steps.
• How equity, literacy, and interoperable data shape ACNU tools.
• A sponsor roadmap covering education, alignment, and retail strategy.

Chapters
00:00 Introduction
02:10 FDA motivations
09:30 Barriers driving nonadherence
14:20 ACNU structure and populations
20:15 Financial implications
27:30 Forecasting and consumer value
33:45 Retail and omnichannel strategy
40:10 Consumer attitudes
46:00 Equity and care design
53:30 Getting started
59:00 Final takeaways

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