Look Back at OPDP Enforcement in 2016 – Focus on Pre Approval Communications

It was another year of low-level enforcement by the FDA Office of Prescription Drug Promotion (OPDP). In fact, if you added the number of letters issued over the past three years it would be one less than the number of the letters sent out for all of 2011.

That said, the 11 letters posted this year are a slight uptick over 2014 and 2015 do offer some interesting insights. But first, a general overview. Of the 11 letters:

  • 3 were Warning Letters, 8 were Untitled
  • All involved only a single communications vehicle (brochure, website, etc)
  • All but 3 of the letters went to pharmaceutical companies that fall outside of the top 50 by sales volume
  • The communications vehicles involved were primarily digital over print, with video being predominent
    • 6 involved video
      • 3 YouTube videos
      • 2 DTC Advertisements
      • 1 video
    • Of those not involving video the vehicles included
      • Email
      • Exhibit Panel
      • Coupon
      • Web page (2)
  • There were 20 violations cited in the letters for this year
  • The letters involved drugs in multiple therapeutic categories.

In virtually every examination of the violations cited in letters, the number one violation is always the minimization or omission of risk information. This year was no exception, with 7 of the 20 violations being in that category. The real point of interest this year, however, was in the number of letters issued for the promotion of an unapproved drug.

There were 4 such letters, which does not sound like a large number in and of itself. The Eye on FDA database on warning and untitled letters tracks letters through 2004 and contains over 300 letters and spans more than 1000 violations. In all that time, the number of letters involving the promotion of an unapproved compound were only 13 (all involving very small companies). That means that nearly one-fourth of all the letters issued for unapproved drug promotion in the last 12 years were issued in 2016, perhaps a signal that this has been a watch area for OPDP or that the agency has intended to make a point about it.

The issues that FDA cited in the letters had to do with a combination of factors including use of a trade name, referring to an indication and use of conclusory language or tone with respect to the establishment of safety and efficacy. You can view the 3 letters here, here and here.

Note: A typo was corrected after the initial publication of this posting to reflect 4 letters for pre-approval promotion rather than 3.

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