With only 2 warnings in 2017, pharma's ad police hits historic low

As the end of the year nears, the pharma industry can usually look back at FDA enforcement letters for insight into the agency's thinking and guidance on marketing communications. But this year, there’s not much to review.

The Office of Prescription Drug Promotion (OPDP) has issued only two letters so far in 2017. Last year at this same time, OPDP had issued five letters, with six more to come in December for a total of 11 warnings or untitled letters to drugmakers.

The number of letters sent by OPDP to pharma marketers has been in general decline for years. From a high of 156 letters in 1998, OPDP letters have dwindled since 2000. In 2015, the OPDP sent just nine letters to pharma companies for marketing violations, down from 10 in 2014 and 24 in 2013.

The two so far this year have been an untitled letter to Orexigen charging that its TV ad for weight-loss drug Contrave downplayed risks and a warning letter (PDF) to Cipher Pharmaceuticals over a professional detail aid for its opioid antagonist ConZip.