2021 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2021 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research (CBER), the Office of Product Evaluation and Quality (OPEQ) of the Center for Devices and Radiological Health (CDRH), and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA). OCBQ did not issue any advertising and promotion enforcement letters in 2021. We examined the 25 advertising and promotion letters issued by OPDP, OPEQ, and OMDRHO, and analyzed the most frequently cited allegations. This alert summarizes the letters and other enforcement trends.