The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective medications and offers a unique market opportunity. Here’s why ACNU matters—and how your organization can lead the way.

What is ACNU?

ACNU is a new pathway that bridges the gap between prescription and over-the-counter (OTC) products involving an additional layer of protection (condition) to ensure safe and proper product use by the consumer. It allows certain drugs, such as those for chronic conditions, to be available without a prescription if additional measures are implemented to ensure proper use without healthcare-provider supervision, such as a self-selection test or instructional video to confirm understanding of the product’s correct use. ACNU is justified when nonprescription labeling alone, supported by behavioral studies, is insufficient for self-selection or correct use of a product. While ACNU safeguards may incorporate digital tools, it is important to strategically consider overreliance on technology to prevent unintended access barriers. The ACNU should promote health equity by making the process as accessible as possible, supported by robust documentation to meet FDA regulatory expectations.

The Role of Real-World Data

ACNU also creates opportunities to use and generate real-world data (RWD) and evidence (RWE) to inform regulatory decisions, including new indications, labeling updates, and expanded marketing opportunities. For example, data from an ACNU could provide insights into consumer behavior, safety, and effectiveness, helping drive further regulatory innovation.

A Real-World Use Case: Statins for Cardiovascular Health

A study in the Journal of the American College of Cardiology shows how ACNU could transform access to statins for cardiovascular risk (A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication). Less than half of eligible patients receive statin treatment due to barriers such as limited provider access or hesitance to seek care. By making low-dose statins nonprescription, with digital risk assessments to ensure proper self-selection, ACNU could help millions of consumers prevent heart disease while maintaining rigorous safety standards.

How ACNU Benefits Consumers and Companies

For Consumers:

  • Accessibility: Reduce reliance on healthcare visits and provides more affordable options for OTC products with ACNU.
  • Health Equity: Offer a novel strategy to address unmet healthcare needs.
  • Safety and Efficacy: Ensure proper use with safeguards.

For Companies:

  • Expanded Market Reach: Transition certain prescription drugs to ACNU.
  • Thought Leadership: Develop consumer-friendly, ACNU-compliant tools to build trust and ensure safe use. Potential for cross-cutting applications, including REMS.
  • Streamlined Pathways: Align with global self-care trends, accelerating market entry and differentiation.
  • RWD/RWE: Contribute to improved public health outcomes.

ACNU: More than Just a Final Rule

ACNU is a transformative framework that could reshape how consumers access medications and how companies innovate. Lachman’s expertise can help guide your organization through ACNU strategy, regulatory considerations, tool development, and compliance. Contact us at LCS@LachmanConsultants.com to learn more.