Drugs

FDA Draft Guide on Medical Product Communications

David McFarland

— 2 min read
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FDA has posted a new draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” dealing with how the agency evaluates firms’ medical product communications that present information that is not contained in, but may still be consistent with, the FDA-required labeling. The document says FDA determines whether the representations or suggestions in a communication are consistent with a product’s FDA-required labeling by considering the following three factors, which all must be met:

Factor 1: How the information in the communication compares to the information about those conditions of use in the FDA-required labeling identified in the bullets below (if the answer to any of the following questions is yes, then the communication is not consistent with the FDA-required labeling): 

  • Indication – Do the representations/suggestions about the product relate to a different indication than the one(s) reflected in the product’s FDA-required labeling?
  • Patient Population – Is the patient population represented or suggested in the communication outside the approved/cleared patient population reflected in the FDA-required labeling?
  • Limitations and Directions for Handling/Use – 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 FDA-required labeling?
  • Dosing/Administration – 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 FDA-required labeling?

Factor 2: Whether the representations/suggestions in the communication increase the potential for harm to health relative to information reflected in the required labeling. “If a communication alters the benefit-risk profile of a product in a way that may result in increased harm to health, this indicates that the communication is not consistent with the FDA-required labeling,” the agency says.

Factor 3: Whether the directions for use in the FDA-required labeling enable the product to be safely and effectively used under the conditions represented/suggested in the communication. If the answer is no, then the communication is not consistent with the FDA-required labeling, the guidance says.

The guidance also includes examples of some general types of information that could be consistent with the FDA-required labeling. However, the document includes a caveat that if the representations or suggestions in a firm’s communication are false or misleading, the communication would misbrand the product and could subject the firm to enforcement action regardless of whether the communication is consistent with the required labeling. Examples include: 

  • Information based on a head-to-head comparison study of a medical product for its approved/cleared indication to another medical product approved/cleared for the same indication.
  • Information that provides additional context about adverse reactions (e.g., the FDA-required labeling for a product identifies nausea as a potential adverse reaction and further indicates the product can be taken with or without food. A firm’s communication about the product provides information about how taking a product with food might reduce nausea).
  • Information about the onset of action of the product for its approved/cleared indication and dosing/use regimen (e.g., the FDA-required labeling for a product approved/cleared to treat major depressive disorder does not contain information about onset of action prior to the point in time designated as the study’s endpoint, and a firm’s communication provides information indicating that the product shows an effect relative to the control at two weeks).
  • Information about the long-term safety and/or efficacy of products that are approved/cleared for chronic use (e.g., a firm provides postmarketing information for its product, which was approved/cleared for chronic use based on 24-week study data, regarding persistent safety and/or efficacy over 18 months).

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