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 today’s communications environment is fast pace and quickly-changing.
The trickle of visible enforcement raises questions as to why there has there been a drop in enforcement activity and whether the drop represents a shift in emphasis or new policy?
This year, Amherst Pharmaceuticals, LLC and Magna Pharmaceuticals, Inc., received a Warning Letter on November 14, 2017, regarding Zolpimist and the way it was advertised online and at an exhibit booth. OPDP took issue with false or misleading claims about the risks associated with, and the efficacy of, the drug. OPDP also noted that the materials were not submitted at either the time of initial dissemination or publication as is required under the Code of Federal Regulations.
Cipher Pharmaceuticals, Inc., received a Warning Letter for CONZIP in August 2017 for its professional detail aid being “false or misleading because it omits important risk information associated with the use of ConZip” within the FD&C Act.
Orexigen Therapeutics, Inc., received 2017s only Untitled Letter for CONTRAVE in May 2017 for a television ad that made false or misleading representations about the risks and side effects associated with Contrave.
It is possible that this drop in Letters shows that the FDA is shifting its focus in enforcement to areas where there is greater risk, as there have been several Letters issued about violations that leave some wondering what the element of risk involved is.