FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle Management

In 2012, driven by an effort to address the undertreatment of common diseases and conditions within the United States, FDA embarked on a journey to create a regulatory framework to increase direct consumer access to drug products, such as some drug products that are currently available only by prescription including those that treat chronic diseases or conditions.
After a public hearing and multiple workshops, FDA proposed a rule in June 2022 to establish requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU) to broaden the types of drug products FDA could approve as nonprescription. In the U.S., there are only two classes of drugs - prescription and nonprescription. The rule does not propose to create a new class of drugs; however, as proposed, a nonprescription drug product with ACNU is distinct from other nonprescription drug products in that the consumer must complete some required “condition” prior to gaining or continuing access to the drug product. Further, a nonprescription drug product with an ACNU can be marketed at the same time as the identical prescription drug product.
The development of an ACNU may be initiated at any point in the drug product lifecycle. Because an ACNU may only be proposed when labeling is insufficient for consumers to self-select or use the drug product in the nonprescription setting, consumer studies must be conducted to justify the necessity of an ACNU. Additionally, consumer studies must demonstrate that consumers exhibit appropriate behavior without the involvement of a healthcare provider. For example, an ACNU may be implemented to conduct a self-assessment (e.g., similar to tele-health via a technology platform), to assist the consumer in determining appropriate diagnosis and conditions for use prior to gaining access to the drug product. As another example, the ACNU might be a mechanism to assess diagnostic results prior to receiving continued product refills. Essentially, when limitations of labeling present challenges for adequate communication of information, technology solutions could reduce barriers to consumer access and ongoing usage.

This session will provide an overview of the background and requirements of the proposed rule for a nonprescription drug product with an ACNU and discuss the regulatory and commercial implications that may enable greater consumer access. This novel proposal has significant implications for the development of lifecycle management opportunities.