For much of 2016, FDA seemed on pace to issue a record-low number of citations for Rx advertising, but in an end-of-year flurry, the agency issued six enforcement letters, bringing the tally to 11 – two more than the agency’s Office of Prescription Drug Promotion issued in 2015. That figure was a record low, which FDA retroactively matched for 2014 when it withdrew a letter to Pacira Pharmaceuticals Inc. regarding the promotion of Exparel (bupivacaine liposome injectable suspension).
The agency withdrew the Pacira letter in settling a lawsuit over FDA’s interpretation of Exparel labeling. (Also see "FDA...
