Our Website Uses Cookies 


We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.


For more information, please contact us or consult our Privacy Notice.

Your binder contains too many pages, the maximum is 40.

We are unable to add this page to your binder, please try again later.

This page has been added to your binder.

2019 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

February 24, 2020, Covington Alert

This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 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) at 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 2019. We examined the 17 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.

Share this article: