FDA’s Office of Prescription Drug Promotion (OPDP) enforcement is intensifying, reshaping what pharma can say and show in promotional materials. A compliance analysis described a rapid expansion in OPDP letters compared with 2024, with particular focus on how tone, imagery, and risk presentation may be interpreted as misleading. The same analysis notes pharma companies may face a stricter compliance bar as FDA seeks additional statutory authority around fair balance and misbranding risk tied to DTC advertising. The enforcement posture is framed as part of broader FDA activity over the last few years. For marketing teams and medical affairs, this increases the operational burden of creative review and evidence consistency checks across campaigns.