Episode 26| Nicholas Hall Panel Discussion 1: Nonprescription Access to Drug Treatment
- Only Healthcare Podcast
- Nov 3
- 3 min read
Updated: Nov 11
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In this episode of the Only Healthcare Podcast, recorded live at the Nicholas Hall North America Conference, our panel explores how the FDA’s new Additional Condition for Nonprescription Use (ACNU) rule is reshaping the future of consumer healthcare.
Hosts Randy Vogenberg, PhD, and Mary Alice Lawless are joined by experts Jim Parker and Bob Sterling to unpack the first major change to U.S. drug regulation since 1951. Together, they discuss how ACNU opens new pathways for safe, affordable, and equitable access to medications—bridging the gap between prescription and over-the-counter treatments.
Listeners will gain insight into the public health potential of nonprescription statins, the role of health plans and employers, the impact on retailers and PBMs, and how this policy could reduce costs while improving patient outcomes.
Key Topics Discussed:
Regulatory shift: ACNU as a modern pathway for nonprescription access, aligned with recent executive actions and FDA priorities
Public health impact: Potential to reduce undertreatment in large disease areas and improve equity and affordability
Statins case study: Why past OTC attempts stalled and how data, tech, and consumer readiness change the outlook now
Plan design trends: Movement toward leaner coverage and greater consumer out-of-pocket costs, with FSAs and HSAs playing a larger role
PBM and data dynamics: How coverage, step therapy, prior authorization, and data ownership shape adoption
Retail execution: The need for coordinated rollouts, better consumer journeys, and behind-the-counter learnings
Operationalization: Ongoing tracking, documentation, and consumer identity verification for ACNU programs
Exclusivity and IP: Three years of exclusivity when clinical trials are required, plus differentiation through proprietary condition algorithms
Market outlook: Mixed pace of adoption, first-mover advantages, and opportunities for innovators to set standards
Chapters
00:00 Introduction and conference context
02:00 Policy backdrop and the ACNU rule
07:00 Lessons from past statin switch efforts and what changed
12:00 Consumer compliance barriers and undertreated populations
16:00 Health plan and employer perspectives on coverage and access
21:00 Retail readiness and distribution opportunities
26:00 Implementation versus operationalization and ongoing compliance
31:00 Exclusivity, competition, and innovation opportunities
35:00 Closing insights and next steps
Hosted by:
Michael Navin & Dr. Randy Vogenberg
For feedback or to suggest topics for future episodes, reach out to us at onlyhealthcarepodcast@gmail.com.
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Hosted by: Michael Navin & Randy Vogenberg, PhD
This Podcast is sponsored by:
Peek: Peek is reimagining access through innovation, technology, connectivity, and partnership. Peek offers a comprehensive and unique suite of solutions to help clients improve access and affordability for prescription drugs.
The Peek Meds Marketplace is one of Peek’s differentiated offerings that gives employers a revolutionary new approach to controlling runaway prescription costs for their employees by providing unprecedented transparency, simplicity - and cost savings. The Peek Meds Marketplace aggregates cash discount cards, manufacturer copay offset programs, and an employee’s insurance information to provide a holistic and personalized view of prescription price options. This easy-to-use platform offers a one-stop-shopping experience for prescription drugs.
Peek’s team has decades of experience in the pharmaceutical industry and offers various services to biopharma manufacturers, brokers, benefits consultants, third-party administrators, and employers. Visit peekmeds.com to learn more.
Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.
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