The FDA has issued a proposed rule (here) to expand certain new conditions of use for OTC products.  When an OTC product is approved through an NDA, it should have all of the necessary information in the Drug Facts section of the label so the consumer can properly select whether the product is appropriate for them (self-selection) or can de-select themselves if they should not use the product for whatever reason.

FDA has decided to propose this regulation to make something like a mini-REMS available to patients to help them select or de-select themselves.  In this proposed rule, the “FDA is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU), which is a 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.” Labeling is sometimes limiting on an OTC product and this rule (if and when it is finalized) “is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.”

The rule would establish:

  • Additional application requirements;
  • Labeling requirements; and
  • Additional postmarketing reporting requirements for the additional condition of nonprescription use (ACNU) for both NDA holders and ANDA holders.

NDA holders would be required to submit a separate application for the ACNU. “Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select or appropriately actually use, or both, a drug product correctly in a nonprescription setting, an applicant may submit an application proposing an ACNU that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU.”  Or as I like to call it, a mini-REMS.

To gain approval, these ACNU products will likely be required to perform “[C]onsumer studies [which] can help demonstrate that the requirement for adequate directions for use is met. These studies may include label comprehension studies, self-selection studies, actual-use studies, and other human factors studies.”

FDA discusses the background of this rule making as it relates to the public meeting it held and inquiries from other interested parties. The rule would apply to only approved drug products that are marketed as prescription drug products, and as noted above, a separate NDA would be required; however, FDA indicates that it would accept a right of reference to its previously approved NDA product and would therefore it would limit the potential work to establishing appropriate labeling, as well as the information to support the ACNU. In certain instances, the FDA explains a 505(b)(2) application may be used (read this section of the rule carefully).  The Rx product and the ACNU product can be both marketed, in which case there are likely other indications for the product that can only be marketed with the Rx indications.

The rule discusses NDA and ANDA requirements and describes how “alternatives to the way the ACNU is operationalized in the previous example, which involves administration of a questionnaire using a website, might include: (1) administering the questionnaire using a display screen at a pharmacy kiosk, (2) administering the questionnaire using a mobile application, and (3) administering the questionnaire using an automated telephone response system.”  As you can see, there is a step that the consumer must take to receive the OTC product with an ACNU.  There may be a number of ways this can happen, and the Agency describes a few, but notes that the operationalization of the elements for an NDA and ANDA product do not have to be the same.

Please read the proposed rule in full and make comments.  The impact on the pharmacy or retail location that stocks the products will likely be a big issue.  The use of in-store kiosks or other options may impact floor space considerations.  This is likely going to be a complicated process to implement so follow the comments and dialogue as best you can.   Great idea, theoretically, but the devil as always, is in the details.