3-Factor Approach for Product Communications: FDA

FDA has outlined a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent with the product’s agency-required labeling. The factors come on the heels of a related guidance entitled Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers Guidance for Industry.

Speaking at a Food and Drug Law Institute advertising and promotion conference in Washington, DC 10/16, CDER Office of Prescription Drug Promotion policy analyst Elizabeth Pepinsky highlighted the three factors that must be satisfied to be considered acceptable and consistent with FDA-required labeling (CFL). They are:

Factor 1 — How does the information in the product communication compare to information about the conditions of use in the product’s required labeling?

Factor 2 — Does the information in the product communication increase the potential for harm to health relative to the information in the product’s required labeling?

Factor 3 — Do the directions for use in the required labeling enable the product to be safely and effectively used under the conditions suggested in the product communication?

Factor 1 gets the most scrutiny, according to Pepinsky, and includes four principles that product communications must meet in order to be considered CFL. All of the principles need to be answered “no” to be considered CFL, she told the conference. They are:

Principle 1 — Do the representations/suggestions in the communication relate to a different indication than the one(s) in the required labeling?

Principle 2 — Is the patient population represented/suggested in the communication outside of the approved patient population in the required labeling?

Principle 3 — Do the representations/suggestions in the communication conflict with the use limitations or directions for handling, preparing, and/or using the product reflected in the required labeling?

Principle 4 — Do the representations/suggestions about the product conflict with the recommended dosage or use regimen, route of administration, or strength(s) (if applicable) set forth in the required labeling?

Examining Factor 2 on whether the product communication increases the potential for harm to health, Pepinsky said the agency analyzes whether use of the product “in accordance with the product communication would reasonably be expected to introduce new risks or materially increase the rate of occurrence or severity of existing risks included in the FDA-required labeling,” If so, the product communication is not CFL, she said, and this includes potential for harm from abuse or misuse, or the potential for harm to the health of humans from certain animal drug uses, or the potential for harm to health from secondary exposure to certain medical products.

With Factor 3 and whether the directions for use in the labeling enable the product to be safely and effectively used, Pepinsky said the agency evaluates if required labeling includes sufficient information about potential or expected risks and effects of using the product as presented in the communication. Also, it looks at whether the required labeling includes appropriate context for unique considerations associated with using the product as suggested by the communication.