The FDA OPDP issued enforcement letters have been on a steep decline since 2010. This article examines the numbers of OPDP letters issued, they were issued for, and what it may mean for the compliance industry.
Tom Abrams, FDA’s Director of the Office of Prescription Drug Promotion (“OPDP”), has long been a featured speaker at major industry compliance conferences and meetings. Every year he outlines the efforts of OPDP to keep the pharmaceutical industry compliant with FDA’s advertising and promotion rules. However, in conjunction with recent setbacks with off-label promotion and commercial free speech litigation, Agency watchers have noticed a precipitous decline in enforcement letters issued by OPDP. In fact, for 2016, OPDP has issued only 4 letters, of which 1 is a Warning Letter. This is down from 9 letters in 2015 and an all-time high of 52 in 2010.
Read Full Article in the November 2016 Issue of Life Science Compliance Update