The US Food and Drug Administration (FDA) is preparing to finalize a new rule that will create an entirely new pathway to market familiar Rx drugs without a doctor’s prescription by including “additional conditions for nonprescription use” (ACNU).
ACNU
Learn About Consumer Studies for Additional Conditions for Nonprescription Use
What are Additional Conditions for Nonprescription Use (“ACNU”)?
The US Food and Drug Administration (FDA) is preparing to finalize a new rule (targeted for Q2 2024) that will create an entirely new pathway to market familiar Rx drugs without a doctor’s prescription by including “additional conditions for nonprescription use” (ACNU).
An “additional condition” is a technology tool (such as a website, mobile app, kiosk, or automated telephone response system) that stands as an interface or intermediary between a nonprescription consumer and the product to help ensure:
- Appropriate self-selection and/or
- Appropriate actual use
without the supervision from a healthcare professional. For example, an ACNU could require a prospective user to:
- Respond to a set of questions on a self-selection test via a mobile application, or
- View labeling that describes how to appropriately use the nonprescription drug product and respond to question to confirm understanding.
What is the Purpose of ACNU?
This new marketing pathway is expected to allow drugs for chronic or more difficult-to-self-recognize conditions to be approved for nonprescription sale. This means pharma innovators and manufacturers will now have new ways to market their existing products or bring new products directly to an expanded audience of nonprescription users by way of ACNU.
According to the FDA, the ACNU pathway is intended to increase options for safe and effective nonprescription drug products and expand consumer access, which “could improve public health by broadening the types of nonprescription drug products available to consumers.”
Importantly, ACNU will only apply in cases where the FDA determines that labeling alone (in other words, the OTC Drug Facts Label) is insufficient to ensure appropriate self-selection and/or actual use by nonprescription consumers.
How Can PEGUS Help with Switching a Product from Rx to Nonprescription with ACNU?
PEGUS has already worked on multiple nonprescription candidates that rely on technology tools, including self-selection studies, human factors/usability studies to test the software user interface, and studies designed to evaluate consumer understanding of data capture screens.
We have extensive experience designing and testing OTC labels with required companion technology tools and we have built partnerships or collaborations with technology providers. We understand the needs of FDA’s Office of Nonprescription Drug Products (ONPD) and are skilled at designing and executing the self-selection and actual use research that will be needed to support your ACNU approval.
Interested in learning how ACNU could benefit your existing Rx product? Click here or call 801-990-6126 to talk with our PEGUS scientific consultants.
