On June 2022, the FDA introduced a new regulation aimed at establishing criteria for over-the-counter drugs that carry an Additional Condition for Nonprescription Use (ACNU). This initiative seeks to expand the range of drugs that the FDA could authorize for over-the-counter use.
In anticipation of an innovative proposal, the FDA suggests offering a greater diversity of over-the-counter drugs by introducing the context and prerequisites of the suggested regulation regarding an over-the-counter drug with ACNU.
Through this substantial diversity, it creates opportunities related to product lifecycle management and the development of new products and exploring the regulatory and commercial implications that could expand consumer access.
- ACNU is drug product that could be marketed without a prescription if an applicant implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner
- The access to medicine defined by individual’s characteristics:
- No HCP = non-prescription, but different from an OTC
- “Condition” must be necessary.
- Appropriate for a subset of consumers appropriate to self-treat.
- Intended to increase access to medications for undertreated diseases and conditions.
- ACNU can co-exist with an Rx NDA (unlike an OTC).
- May be considered at any point in a product lifecycle.
- Potential for Waxman Hatch Protection.
- Current Non-prescription drug products are intended to provide temporary relief rather than chronic diseases.
- Need More Information: Drug Facts Labeling alone is not enough, for certain drug products, limitations of labeling present challenges for adequate communication of information needed for consumers to appropriately self-select or use the drug product without the supervision of a healthcare practitioner.
- Need for behavioral studies to demonstrate appropriate selection and use in non-prescription setting.
FDA: ANDA X NDA
- Safety and effectiveness demonstrations continue to apply.
- Additional requirements are added: Application requirements, labeling requirements, and post-marketing reporting requirements.
- NDA and ANDA applicants would be required to submit a report with information concerning any incident of failure in the implementation of an ACNU, such as a consumer gaining access to the drug product without fulfilling the ACNU.
- NDA applicants would also be required to describe the ACNU and submit information to support the ACNU.
- Separate application for the approval of a nonprescription drug product with an ACNU, rather than a supplement to an application approved as a prescription drug product.
ACNU can address patient barriers how:
- enable novel patient access solutions.
- Solutions envisaged to enable.
- selection, potential innovation areas (Self-Directed, Chronic conditions, Diagnostic testing, Medication refills, Use instructions)
Requirements for working with ACNU
Understand barriers to use – Common barriers:
- To address the barriers to use, an applicant must implement to ensure consumers’ appropriate self-selection or appropriate actual use, or both, of the nonprescription drug product without the supervision of a healthcare practitioner.
Address Barriers to use – Possible Approaches:
- An applicant could propose an ACNU that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a mobile application (“app”) or an automated telephone response system to purchase the nonprescription drug product.
- Could be, that the ACNU could serve as a mechanism for evaluating diagnostic outcomes before authorizing further product refills. Essentially, when the limitations of product labeling pose difficulties in effectively conveying information, technological solutions have the potential to eliminate obstacles and improve consumer access during continuous usage.
- The development of ACNU may be initiated at any point in the drug product lifecycle.
- 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.
- Consumer studies must demonstrate that consumers exhibit appropriate behavior without the involvement of a healthcare provider.
FDA targets completion of the rule in April 2024
- New regulatory pathway for direct patient engagement & access
- Can co-exsit with an existing Rx NDA
- Non-prescription but an additional “condition” must be necessary.
- “Condition” may address selection, use, or both.
- Clinical studies required to demonstrate appropriate patient understanding/behavior.
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