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New FDA Guidance on OTC Products

Innovative Thinkers: FDA wants YOU

FDA just released a very brief (barely three pages of actual text) guidance promoting innovation in new drug applications (NDAs) involving nonprescription (aka over-the-counter, OTC) drug products.

In the guidance, “Innovative Approaches for Nonprescription Drug Products, Guidance for Industry’ (CDER July 2018) FDA describes “…two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting.”

The guidance specifically mentions the 505(b)(2) regulatory pathway as suitable for this creative approach: “These innovative approaches may be useful for applicants intending to develop and seek approval of certain nonprescription drug products through the submission of a new drug application, including an application submitted pursuant to section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. (FD&C Act) (21 USC 355)” FDA also notes that this approach may be useful for combination products.

Nonprescription Drug Products and Innovative Thinking

The key message of the guidance is that an NDA can be approved for a nonprescription product under circumstances where more than the format and content requirements for an OTC product are needed for safe and effective use of the product. The guidance points out that “Nonprescription drug products must comply with applicable labeling requirements for OTC drug products under 21 CFR part 201, including, but not limited to...” these requirements. (emphasis added) Specifically, the guidance points to 21 CFR 201.66, which requires the DFL. The guidance states “In instances where the DFL alone would not be sufficient, an applicant may consider proposing innovative approaches, in addition to the DFL, to ensure that the drug product is safe and effective for use as a nonprescription product.” FDA states that it believes that the innovative approaches it describes could lead to the approval of a wider range of nonprescription drug products.

So, what are these two innovative approaches?

  • Labeling in addition to the DFL for a nonprescription drug; for example:
  • Information leaflets or similar documents in the product carton or container
  • Text or images on a video display, including interactive displays
  • Website information
  • Statements or questions in a mobile application
  • Additional conditions for safe and effective use; this approach emphasizes some type of self-selection process, for example:
  • Before purchasing the product, the consumer must respond to a set of questions on a self-selection test in a mobile application
  • Before purchasing the product, the consumer is required to view and affirm viewing of text or video images describing the appropriate, correct use of the nonprescription product

Strategy for Innovative Nonprescription Drug Products

These descriptions and examples present a multitude of opportunities for creative approaches to approvals for nonprescription products which otherwise would likely not obtain nonprescription status. Predictably, the guidance encourages potential applicants interested in applying such innovative approaches to discuss their development plan with FDA.

Contact Premier Consulting to learn how we can be of help aid you in developing your nonprescription product.


William Stoltman, JD
Senior Director of Quality Assurance / Compliance