In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription pharmaceutical products. Of the five letters, three were Warning Letters and two were Untitled Letters. The number of letters last year represents a record low for the total number of enforcement letters issued by OPDP related to pharmaceutical advertising and promotion.

Risk Presentation Was the Focus of Four of the Five Letters -

The focus of OPDP’s 2017 enforcement letters was generally similar to recent years, with a majority of the letters focusing on presentation of risk information. FDA cited four of the five companies for false or misleading presentation of risk information.