DTC and Regulatory Enforcement

FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising.  Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been guidance available for both print and broadcast.

From time to time, I have used this space to look at different communications platforms to look at OPDP enforcement patterns consulting the Warning/Untitled Letter database that I have put together.  As a reminder the database spans the years 2004-2014, inclusive. There are 294 letters covering over 1000 violations over that period and among other items tracked are the company involved, the product name, the treatment area, the type of communications vehicle and of course the violations, among others. I have pulled together an overview of those letters involving direct-to-consumer advertising.  Here are a few of the factoids:

  • Of the 294 letters in the database issued since 2004, 58 (19.7 percent) of them involved DTC communications vehicles making it the largest category of communications vehicles involving a letter, followed by Webpages/sites – 56 (19.1 percent) and then Sales Aids – 30 (10.2 percent);
  • Of the 58 letters regarding DTC advertising, 22 were Warning Letters (38 percent) which is slightly higher than the ratio of Warning versus Untitled Letters for all letters issued in this time frame (33 percent);
  • There were 18 letters involving Broadcast (either radio or TV) while there were 40 letters involving print ads (including Journal Ads);
  • The 18 letters for Broadcast DTC had a total of 46 violations (2.5 violations on average) while the 40 letters involving print ads had a total of 107 violations (2.7 violations on average).

The most common violation cited in Warning or Untitled letters is Risk Omission or Minimization.  Here is a profile comparison of  proportions for each:

One can see that Risk Minimization or Omission was the primary violation for DTC as well as all letters, but that the second highest  number of violations in DTC were superiority claims while the second highest for all letters was Overstatement of Efficacy, which may lead one to consider that DTC ads as a communications vehicle may be particularly susceptible to a presentation that implies superiority more readily than most other promotional communications vehicles.

Next time I do a comparison, I’ll look at Websites, the second most common communications vehicle involved in a violation that triggers a Warning or Untitled letter.

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