Webinar
Flipping the switch: Entering a new Rx-to-OTC switch era in the United States

Rx to OTC switch remains one of the most strategically important growth levers in consumer health—but the rules of engagement are evolving. As consumer self care behaviours accelerate and healthcare system pressures intensify, the FDA’s Additional Condition for Nonprescription Use (ACNU) framework is redefining how prescription products can transition to OTC access.

In this on demand webinar, IQVIA Consumer Health and industry experts from Idea Evolver explore how ACNU is reshaping Rx to OTC regulatory strategy in the United States—enabling more ambitious switch candidates, expanding consumer access, and setting new expectations for evidence generation, digital enablement, and commercial execution. Discover how leading organisations are navigating this new switch environment to unlock sustainable growth and maximise the value of their portfolios.

Key discussions you won’t want to miss:

  • How to unlock scalable growth with next generation Rx to OTC switch
    shifting from one off transitions to sustainable, behaviour driven access models
  • Why ACNU opens new pathways for more ambitious switch candidates
    enabling access where traditional labelling alone would not be sufficient
  • What landmark U.S. switches reveal about accelerating access
    and how evolving FDA thinking is creating new commercial opportunities
  • How to build the evidence regulators require
    demonstrating safe, effective use through real world consumer behaviour and robust data
  • How digital tools and AI enable safe, scalable consumer access
    supporting self selection, adherence, and engagement in real world settings

Entering a New RX to OTC Switch Era
in the United States

See key webinar timecodes below:

  • 05:56 — The evolving Rx‑to‑OTC switch landscape
    Why switch is shifting from convenience to a strategic, behaviour‑driven growth lever
  • 09:55 — Landmark U.S. switches and what they signal
    What naloxone and oral contraception approvals reveal about FDA priorities and access
  • 12:20 — Introducing ACNU: a new regulatory pathway
    How additional conditions are expanding what’s possible for OTC access
  • 17:13 — How ACNU is reshaping the switch model
    Moving beyond labelling alone to real‑world delivery and execution
  • 24:10 — The behavioural evidence regulators expect
    The critical questions sponsors must answer to demonstrate safe use
  • 29:03 — ACNU in practice: the role of digital and software
    Why intuitive consumer journeys rely on robust, highly controlled systems
  • 37:28 — Identifying high‑potential switch opportunities
    Where future ACNU‑enabled growth is most likely to emerge
  • 46:30 — Key takeaways for sponsors
    What this new switch era means for strategy, capability, and execution

Ready to accelerate Rx‑to‑OTC switch success in the U.S.?
Connect with our experts to understand how ACNU can unlock new regulatory pathways, expand access, and drive growth.

Rx to OTC switch in the U.S. has changed. Most strategies haven’t.
The U.S. Rx-to-OTC switch landscape is evolving—but success now depends on designing for real world consumer behaviour, not labelling alone. With the introduction of ACNU, organisations must rethink how evidence is generated, how digital tools are applied, and how access is enabled at scale to meet new FDA expectations and unlock growth.
Rx to OTC switch: From strategy to approval

 

Delivering a successful Rx to OTC switch requires an integrated approach across regulatory strategy, evidence generation, and real world implementation. Explore how IQVIA supports programmes end to end—from concept and study design through to approval—combining real world evidence, digital health solutions, and global expertise to drive successful outcomes.

Planning an Rx-to-OTC switch?

IQVIA Consumer Health helps brands navigate every stage of the switch journey—from strategy and evidence generation to label optimisation, self-selection and launch readiness.

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