OPDP Letters Remain on Decline

The Office of Prescription Drug Promotion (OPDP) is known for monitoring company communications about medical products and when it considers those communications to be outside of regulatory parameters, issuing a letter warning the company of such promotion. For relatively minor violations, OPDP issues an Untitled Letter; for more serious violations, OPDP will issue a Warning Letter.  As can be seen in the below graph, in the late 1990s, OPDP was issuing over 100 Warning and/or Untitled Letters annually. Since that time, there have been peaks and valleys when it comes to the number of Letters issued. Nothing compares to the recent years of 2014 through present, though. In 2014, OPDP issued ten Letters; in 2015, nine Letters; and in 2016, eleven Letters. For 2017, though, there have only been three letters issued: two Warning Letters and one Untitled Letter. Interestingly, last year followed a similar path up to this point. Very few Letters were issued through October 2016, and then during the last two months of the year, issued more Letters than it had all year. Therefore, it is hard to predict that we will see another year of single-digit Letters issued by OPDP, but it may be possible. This seeming lack of enforcement from OPDP is important to industry because the letters provide insight into the way the Food and Drug Administration (FDA) is currently thinking about developments in communication. This helps to fill in the gaps between guidances and can help when...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs