ONLY HEALTHCARE
The “Only Healthcare” podcast reveals shocking truths about the healthcare industry. Why are US Healthcare costs and risks so high? How will new technologies impact the system? What are the challenges in accessing new therapies and treatments? What is happening with Big Pharma and how do they influence other stakeholders in healthcare? Hosted by industry experts Michael Navin and Dr. Randy Vogenberg, to provide you with actionable and inspirational insights on how we can improve healthcare cost, care and accessibility for all.
Hosted by:
Michael Navin & Dr. Randy Vogenberg
Michael's LinkedIn
https://www.linkedin.com/in/michael-navin-7411388/
Randy's LinkedIn
https://www.linkedin.com/in/randyvogenberg/
Sponsored by:
Only Healthcare is sponsored by Peek and the Institute for Integrated Health.
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):
Healthcare benefits, insurance coverage regulations, and business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provide strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning, and advisory on market trends and U.S. healthcare market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. Learn more by visiting https://iih-online.com/.
Music by:
Hanu Dixit, https://www.youtube.com/hanudixit
Disclaimer:
© 2025 Only Healthcare Podcast. All rights reserved.
This podcast and its content, including but not limited to audio recordings, images, and text, are the property of the Only Healthcare Podcast and are protected by international copyright laws. We appreciate all distribution and content sharing. Contact us at onlyhealthcarepodcast@gmail.com to access our media kits, provide feedback or inquire about guest participation. Thank you for listening.
ONLY HEALTHCARE
Ep 34 | ACNU Explained: How FDA’s New Nonprescription Pathway Could Expand Access and Improve Adherence
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 context
01:27 ACNU vs telepharmacy and DTC models
02:48 Simultaneous marketing and provider oversight
03:33 Introduction to compliance and consumer engagement
04:18 Why traditional Rx compliance programs fall short
05:46 Payer and manufacturer cost dynamics
07:05 ACNU as a leadership opportunity for consumer health
07:51 Coverage, payers, and outcomes expectations
08:34 FSAs, HRAs, and MSAs in the ACNU ecosystem
09:57 Pricing stability and consumer affordability
10:45 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/.
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