Recorded live at the Nicholas Hall North American Conference, this special episode of the Only Healthcare Podcast dives into the FDA’s new Additional Conditions for Nonprescription Use (ACNU) pathway and what it means for access, compliance, and the future of consumer healthcare. Host Randy Vogenberg is joined by industry veterans Bob Stirling and Bob Barron, with questions moderated by Mary Alice Lawless. Together, they break down how ACNU differs from telepharmacy and direct to consumer models, why scale matters, and how built-in safeguards could enable safer nonprescription access to certain therapies, including acne treatments. The conversation explores compliance challenges, payer dynamics, employer sponsored accounts like FSAs and MSAs, and why ACNU represents a fundamentally different approach to access that could benefit consumers, manufacturers, and plans alike. This episode provides essential context for anyone tracking FDA policy, OTC switches, market access strategy, or healthcare affordability. Key Topics Discussed • What ACNU is and how it differs from telepharmacy and DTC • FDA safeguards and consumer level decision support • Scale, retail access, and why shelf access matters • Simultaneous Rx and nonprescription marketing considerations • Compliance challenges in traditional Rx models • Implications for payers, coverage, and benefit design • The role of FSAs, HRAs, and MSAs in supporting access • Why ACNU represents a new paradigm for consumer healthcare Chapters with Time Stamps 00:04 Episode overview and ACNU context01:27 ACNU vs telepharmacy and DTC models02:48 Simultaneous marketing and provider oversight03:33 Introduction to compliance and consumer engagement04:18 Why traditional Rx compliance programs fall short05:46 Payer and manufacturer cost dynamics07:05 ACNU as a leadership opportunity for consumer health07:51 Coverage, payers, and outcomes expectations08:34 FSAs, HRAs, and MSAs in the ACNU ecosystem09:57 Pricing stability and consumer affordability10:45 Key takeaways from Nicholas Hall Conference Michael’s LinkedIn Randy’s LinkedIn Sponsored by:Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/. 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/.