In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled Letters and only one was a Warning Letter. As demonstrated in the below chart, this was a record low for the total number of enforcement letters issued by OPDP in a year.

Although the total number of promotion and marketing-related enforcement letters has been decreasing steadily over the last five years, 2014 represented a significant drop with less than half of the letters issued in 2013. One possible explanation for the unusually light year of OPDP enforcement was that OPDP diverted resources typically devoted to surveillance and enforcement actions to the development of guidance documents and other activities. OPDP was involved in the issuance of five draft guidances in 2014 plus a sixth draft guidance in late 2013, an unusually high number. An OPDP representative was also reported earlier this month as indicating that the Office may have devoted increased time last year to core launch promotional compliance reviews as well. Although only time will tell, it is also possible that the slowed pace of enforcement letters may reflect, in part, the continued scrutiny on OPDP’s regulation of drug promotion post-U.S. v Caronia.