Evaluating promotional claims as false or misleading
David B. Brushwood, Caitlin A. Knox, Wei Liu, Kevin Ahmaad Jenkins · American Journal of Health-System Pharmacy · 2013
It is well established that a clinician’s choice to use a Food and Drug Administration (FDA)-approved medication outside what is described in the product labeling does not violate the Food, Drug, and Cosmetic Act (FDCA).1 Product labeling often fails to reflect the most up-to-date standard for patient care. Patients expect clinicians to use innovative practices when it is in the patient’s best interest to do so rather than adhering to a labeling document that often has not been modified for many years. Until recently, it has also been well established that a product manufacturer responsible for labeling a medication may not promote that medication for use in a way that has not been approved by FDA (i.e., off-label use).2 A recent case from the U.S. Court of Appeals for the Second Circuit calls into question this traditional thinking.3 This case currently serves as precedent only within the states covered by that circuit (New York, Connecticut, and Vermont) but could be followed by other circuits. The court ruled that promotional statements for FDA-approved medications are subject only to the requirement that they not be false or misleading. Since there are rarely established facts within clinical science, an occupation that necessarily and successfully deals with both knowns and unknowns, the court’s novel perspective raises the question: “What level of evidence should lead to the conclusion that an assertion promoting the use of a medication is false or misleading?” At a theoretical level, this analysis begins with the foundational question: “What is truth?” At a more operational level, the analysis will lead clinicians to ask: “How much evidence, and what quality of evidence, is sufficient to support a medication safety or efficacy claim as truthful and not misleading?”