Dosage safe for one patient class may not be implied safe/effective for another

Rule

In prescription drug advertising subject to 21 CFR 202.1, a dosage properly recommended as safe and effective for one class of patients or disease condition may not be represented or suggested as safe and effective for a different class of patients or disease condition when that is not the case. FDA applies this same standard, as its own extension of the provision rather than the direct reach of 21 CFR 202.1 (which by its terms governs advertisements), to promotional labeling such as brochures, detailing aids, and sales aids.

Check

In prescription drug advertising subject to 21 CFR 202.1 — and, under FDA's applied standard, in promotional labeling such as brochures, detailing aids, and sales aids — identify any dosage claim made for a patient class or disease condition and compare it against the approved labeling, which is the benchmark for what dosing has been demonstrated safe and effective. A violation exists where the material represents or suggests that a dosage properly recommended for one class of patients or disease condition is safe and effective for another class of patients or disease condition when such is not the case, i.e., when the approved labeling does not support that extension.

Escalate when

Escalate when it is unclear from context whether the material implies (rather than explicitly states) that the dosage extends safely/effectively to a different patient class or disease condition not supported by the approved labeling, or when it is unclear whether the piece functions as advertising versus promotional labeling for purposes of applying this standard.