The drought in enforcement by the Office of Prescription Drug Promotion (OPDP) continued in 2015, as OPDP issued a total of only nine enforcement letters. Two of the nine letters were Warning Letters and seven were Untitled Letters. As demonstrated in the chart below, this was a record low for the total number of enforcement letters issued by OPDP in a year.

The primary driver of this decline in OPDP enforcement activity is unclear, but there are a number of potential explanations. FDA is likely still gauging the ramifications of recent First Amendment cases against the Agency, including by Amarin and Pacira in 2015, as well as the potential impact of any additional challenges. Given the current landscape, it would not be surprising if FDA were more careful and deliberate in determining which letters to issue, as well as requiring multiple layers of review for each enforcement letter.