New Warning Letter Reflects Recent Shifts in FDA Enforcement of Drug Promotion

On August 4, 2023, the FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter targeting a sales aid for a drug approved for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).1 FDA published the letter on August 15, 2023.

The letter reflects several recent developments in FDA enforcement regarding prescription drug promotion, including a general increase in such enforcement and a sustained focus on communications “consistent with” approved labeling (CFL).