FDA Enforcement of Digital Communications – An Update

In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object of the exercise was to (1) examine whether or not there had been an increase in regulatory action letters aimed at digital communications platforms given the enormous increase in the use of the Internet for health seeking behaviors by consumers/patients and the use of digital and social media platforms by pharmaceutical and biotech companies, and (2) to assess if there was a different in the patterns of enforcement versus more traditional means of communications.

The analysis of letters that (1) the letters aimed at digital/social platforms were lower in proportion to traditional communications (56 percent of the letters aimed at traditional, 44 percent at digital). And (2) when you looked at the more serious type of letter – Warning Letters – nearly 3 out of 4 (73 percent) involved traditional communications vehicles and only one-fourth were among social/digital. Finally (3), the rate per year did not show an increase year over year in the proportion of letters aimed at digital/social.

The analysis looked at letters from the years 2008-2012 to capture the ascendency of social media. I thought enough time had passed to do a little update to see if there had been any change in the patters since 2012.

Since then there have only been a total of 38 letters issued 2013-today, inclusive. Those letters represented 40 different communications vehicles. Of the 38 letters, only 14 involved a digital/social communications vehicle.

So, even though the output from OPDP has been extremely low, from what little experience there is with the issuance of regulatory action letters by the agency there has been no increase in attention to digital media over traditional media since 2012. In fact, if anything, enforcement vis a vis digital media is a diminished focus.

What does it mean? That the EyeonFDA Warning Letter database cannot tell us. Does it mean that digital media is safer than traditional? Probably not. Does it mean that more communications occurs in traditional than in digital? We don’t know, but what I do know from a separate data base that tracks social media activity among pharmaceutical companies, as well as the information supplied on patient use of the Internet in seeking health information and huge number of Websites that exist – it is hard to imagine that digital media around healthcare is dwarfed by traditional. Does it mean that FDA doesn’t care as much about digital and social media as traditional? Again, probably not though some might reasonably think, given the track record on guidance in this area, that it might not be a priority.

Finally, does it mean that industry does not need to exercise as much caution when communicating through digital and social means? Definitely not. In the end, what it may mean is that even as new means of communications come (and go) in digital media (See “Live Streaming – Game Changer at Medical Meetings and Beyond“) FDA is still coming to grips with how to regulate the 21st Century from the 20th.

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