FDA’s recently proposed ACNU rule aims to increase consumer access to effective nonprescription drugs by allowing Rx-OTC switches using tech-enabled approaches that go beyond the product label.  However, the rule has been received with controversy as it creates complex questions regarding safety, technology, IP and exclusivity, and is also likely to decrease economic opportunities for switch products.  This panel will unwrap the proposed ACNU rule with topics of discussion including:

• Understanding how this new proposed rule fits into the current regulatory landscape governing OTC drugs
  • Examining what kind of OTC approval system this will create for Rx-OTC switches
• How are consumers vs industry perceiving the rule from an ease of implementation standpoint?
  • What will the criteria be to establish additional conditions of use/safety?
  • Analyzing the potential introduction of a digital platform that consumers can use to establish if the product is right for them
  • Will AI play a role in the software potentially being used?
• Exploring the potential hurdles in ACNU’s implementation journey
• What specific complications may arise when a switch product becomes a generic?
• Contemplating the impact of the proposed rule on financial incentives and opportunities for OTC companies
• Analyzing industry’s comments on the rule and how these could impact the final piece of legislation