DTC and OPDP

It is a different era of enforcement. So far the first quarter of 2017 has not yielded a single regulatory action letter from the Office of Prescription Drug Promotion (OPDP). That said, in December of 2016 OPDP put out more letters in the month of December than had been issued for the preceding eleven months combined. So low enforcement does not mean no enforcement. It may come in lurches.

Next week I am speaking at the DTC Perspectives Conference in Boston providing some thoughts on how research being undertaken by FDA might impact DTC advertising. It seemed like a starting point for having that discussion would be to provide some context with respect to enforcement vis a vis DTC.

You could argue that all promotional speech is DTC.  In my database of warning and untitled letters put out by OPDP over the past several years, you can see a lot of different communications vehicles. This includes the obvious things like websites, broadcast ads, journal ads and then the not so obvious items like a puzzle, a belly band, or even a bathroom stall cling. They are all carrying a communication about a prescription drug product and all have been included as the subject matter of letters from the Office of Prescription Drug Promotion.

But for these purposes, I am looking solely at those promotional communications via traditional paid vehicles in various media – specifically, consumer print and professional journal ads, broadcast radio and television, and web-based banner advertisements.

Let’s first look at how violations in DTC compare to the violations that occur overall. This represents a look-back at all of the letters in the database going back through 2004 to present and compares the top violation categories – Risk Information (either omitted or insufficient), Superiority Claim, Unsubstantiated Claim, Broadening of Indication, Promotion of an Unapproved Use or Promotion of an Unapproved Drug. What you see is that in DTC there is a much larger proportional representation for the omission or minimization of risk information (represented in blue) and for making a superiority claim (represented in orange).

When looking solely to DTC itself, where have the violations occurred?

Interestingly the majority have been in print (combined 56 percent for print ads and journal ads) while only about a combined one-fourth have been in broadcast television or radio. Meanwhile digital has been only about one-fifth as well, despite the fact that by FDA’s own research in assessing 2253 submissions, the trends show that digital promotional pieces are on the rise while non-Internet promotions have been on an even plateau. Since the database goes back through 2004 and social media and internet ascendancy occurred during the latter part of that, one could argue that only later years should be examined. But if you look at enforcement from 2010-2016 vis a vis DTC, the contrast is even more stark. In fact, there appear to be no letters issued involving print ads, journal ads and broadcast television ads.

From this one would have to come to one of three conclusions. (1) Internet/Social Media DTC is done more compliantly than any other form of DTC; (2) After the great issuance of letters involving banner ads in 2009, there is no DTC in Internet/social media; or (3) FDA’s enforcement is not focused in the same place its research points.

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