432 - With reference to PAAB Code section 6.6 (vii), what is the difference between class and category? Would an unbranded patient piece that mentions "treatment" without any specifics be exempt from PAAB preclearance? For further context, the disease state that the piece focuses on can be managed in various ways, including watch and wait.
Jennifer Carroll last edited by
"Class" refers to pharmacological classification (e.g. ACEI, Beta-Blocker, Calcium Channel Blocker). "Category" refers to a higher level in the hierarchy (e.g. "antihypertensive treatment", "blood pressure meds", "drug treatment for blood pressure". I say "higher level" simply in the sense that there can be more than one class in a category. You’ve touched on an interesting property relating to the term "treatment". Although it often refers to drug treatment (especially in the context of APS generated by pharmaceutical companies), it is possible that it refers solely to lifestyle adjustments, medical devices…etc (i.e. completely exclusive of drug therapy). Context is important in cutting through that ambiguity. Generally, the executions I’ve seen don’t stop at the fact that management includes watch and wait. They usually go on to say "…and drugs… to help reduce the risks of heart attacks and death and help improve quality of life". That may or may not be an infraction for the therapeutic area at hand. That’s why the content would be reviewable under section 7.5 of the PAAB code (i.e. so you can find out and adjust accordingly as needed). The point is to ensure that the manner in which medications (even on the conceptual level) are represented vis-à-vis the disease is accurate, balanced, and evidence based.