OPDP Makes a Point on Risk Info and DTC (Updated)

The Office of Prescription Drug Promotion (OPDP) has been particularly low-key this year when it comes to visible enforcement actions expressed through the issuance of Warning or Untitled letters. Up until this week, the office had issued only 5 letters so far this year. That represents a dramatic drop-off in enforcement over the years. In fact, if no more letters are issued this month, this year will represent the least amount of Warning/Untitled letter action in two decades.

That said, this week OPDP decided that it would make a point about the presentation of risk information in broadcast Direct-to-Consumer advertising (DTC) when it posted two letters issued December 12. You can see the letters here and here.

For some time now, the agency has been engaged in research to assess how risk information comprehension is perceived by audiences in DTC advertisements. Recent efforts have focused on evaluating the use of animation in these ads, but earlier the agency was collecting information on the impact of distractions during the viewing of such ads. The agency has also been looking at the impact of ad exposure frequency in processing risk and benefit information.

The letters this week would appear to be a by-product of that research. While some might think that it would be logical for the agency to issue a written guidance that reflected the results of such studies and thereby better inform industry as to regulatory guardrails.  In 2009, a draft guidance did lay out principles for presenting risk information in DTC ads.

It would appear that OPDP is using the letters to make a point, perhaps to reflect the study in which the agency has been engaged. Both of the letters involved  the same communications vehicle – DTC ads – and both cited a single violation – characterized as false or misleading risk presentation.

It is noteworthy that most risk violations in past letters have been the omission or minimization of risk information. Also most letters cover more than a single violation.

In these letters the single violation for each had to do with the conveyance of risk information and both were under similar circumstances. The letters stated that during the “major statement” – or the portion of the ads that convey the risk disclosures – there were distractions such as loud music and attention grabbing visuals that were unrelated to the risk subject matter. OPDP is making the point that the conveyance of risk information in DTC should not be clouded by visual or aural circumstances that are not related to the subject of risk.

Apart from the fact that enforcement has been so inactive, this week’s regulatory action letters were not only interesting from a few other the perspectives.  For example, the past few years the overwhelming majority of letters have been directed at smaller pharmaceutical companies – not ones appearing in the top 50 by sales volume. However these two letters were both directed at larger companies both within the top 25, as might be expected given this involved DTC broadcast television vehicles and therefore break with the pattern.

We’ll be on the look out for any updates to this year’s regulatory enforcement and provide an overview of 2016 in the new year.

Note:  This posting has been updated as of December 16, 9:24 AM. The original version did not reference the 2009 draft guidance document on presenting risk information and suggested that the letters were issued as a result of the research prior to guidance. A reader pointed out the error and the posting has been corrected to reflect the fact that there has in fact been prior guidance on this subject that outlined the principles addressed in the letters.