In the wake of publishing “FDA Communications Oversight in a Digital Era” in last week’s blog post, I have been asked some interesting questions. One of them sought to know whether there was a difference between the types of violations of non-digital (traditional) communications vehicles versus digital.
Again, the paper was based on a data base I compiled that tracks OPDP letters to pharma companies from the years 2004-2013, inclusive, covering nearly 1000 violations cited by FDA. For this study, I specifically examined the years 2008-2012 in order to capture the uptake of social media by both mainstream media as well as patients and industry. For the period, there were 173 letters covering 675 violations. Each violation was characterized as belonging to a non-digital communications vehicle (brochure, advertisement, spoken word, e.g.) or a digital property (website, banner ad, e.g.). There were 385 non-digital violations and 290 digital violations.
Here is a look at non-digital vehicles. You can see that 1 in 3 violations involve either the minimization of risk or the failure to include risk information. The second highest share of the violations goes to the overstatement of efficacy.
The breakdown shows a very different profile for the digital violations, where the failure to include risk information or minimization of risk had a much larger profile (56%) for digital properties rather than non-digital communications vehicles. Why?
Remember 2009 when OPDP (then DDMAC) issued 14 letters regarding 45 brands for online ads? That added a huge number of risk-related violations since the reason those ads were being cited is that the “one-click rule” that everyone thought existed, in fact, did not. That artificially inflated the number of violations related to risk.
When you remove those violations, the two are more similar, though there remains a slightly higher level of risk violations as well as a higher rate of overstatement of efficacy and promotion of an unapproved product. With respect to the unapproved products, these involved 3 oncology products; one involved a Webcast and the rest were Website content.