Tick Tock re Tik Tok and FDA’s OPDP

Tik Tok was first released in 2016. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. While historically, a lot of Tik Tok use has been comprised of individuals releasing videos of them showing off dance moves and physique, the time for embracing the platform by institutional users appears has arrived. This is a familiar pattern, echoing back to the time when bloggers, Facebook and Twitter were dominated by people talking about what they had for lunch, who they were dating and where they were standing. Then commercial interests moved in changing the complexion and makeup of those platforms entirely, with pharma taking up the rear. The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern.

But while FDA’s Office of Prescription Drug Promotion (OPDP), the office responsible for a FDA’s regulatory approach to promotional speech by the pharmaceutical industry, has recently announced research that is aimed at uncovering more about the role and impact of influence of endorsers, that research is covering more mainstream channels , namely television. Earlier research, the agency says, shows that different types of endorsers have different levels of influence, with physicians coming in highest and celebrities coming in lowest. In the newly announced research, the agency will compare reactions among different subsets of viewers by age and education level. What that research will not tell us is, with its extremely high level of viewership, what might the impact of endorsers be on TikTok?

FDA’s OPDP began considering an approach to regulating social media long before Tik Tok came into being. The agency has always maintained that the principles underlying its approach to addressing promotional speech was somewhat platform agnostic – that a video that plays as a commercial on broadcast television is guided by the same principles as those on YouTube. Communicators and marketers would love black and white answers about concrete platforms. But OPDP speaks not in black and white, but gray. And they believe that the principles laid out to date cover pretty much any communications platform.

But in fact, that is not the case as evidenced by the fact that the agency has different approaches for print than broadcast, indicating the medium does, in fact, matter. And FDA made tacit acknowledgement of the fact when it held a public Part 15 meeting in April 2009 to put forth a framework for the discussion of regulating social and digital media, with the aim of developing a guidance related to the unique challenges offered up by new media shortly thereafter. That did not happen and in fact, it was many years before any draft guidance documents emerged and then there were principally two of them that addressed some of what was discussed in the 2009 framework – on Character Space Limitation and on Correcting Third Party Misinformation.

In fact, the medium does matter. In general, social and digital media have begged new and emergent questions related to regulatory oversight than exist within the confines of traditional print and broadcast. For example, the fact that the very basis of social media is sharing content and providing comment on it make it different in terms of impact and perception. More specifically with regard to Tik Tok presenting a myriad of videos varying greatly in subject matter, quality and taste, it is not an unusual for a user to scroll through videos quickly. It is a process that can often result in partial viewing. Many users get just the intro past the viewer before – whoosh – they are gone. So if on a branded Tik Tok risk information is at the end of the vid, how many people will never see it? Once you get the benefit – why stick around for the risk. What is the impact of that? Does FDA know? Should they? How does the medium impact the goal of fair balance, a key principle for FDA’s OPDP.

Another factor in play is that TikTok is content is most likely delivered to individuals, particularly younger people, on mobile devices. Small screens. So what I’m viewing in the way of benefits – and the impact – may be very different from the presentation of voluminous risk information.

Tik Tok aside, the issue of risk presentation somewhat related to the long-outstanding issue of optimizing websites for mobile, about which FDA has said nothing. Yet for many, mobile is the primary access means for Internet use – and therefore health information-seeking behavior. That means the use of links and in particular, their use in optimizing a web site is taking on increasing relevance in relation to mobile sites or video. And yet use of links has never been addressed fully addressed by the agency, even though it was one of the five principle questions posed by the agency in the 2009 public meeting – the only meeting held on the topic of digital and social approaches. FDA spends a good deal of effort in research aimed at how different communications mechanisms impact perception of risk and benefit, where the research is lacking is telling us whether or not the fact there are varied perceptions of risk and benefit actually matters. Given that there is a learned intermediary – a prescriber – between the patient and the product, what is the real issue at hand when communications about the product may result in varied understandings of risk?

As noted in a recent posting, FDA research has been largely focused on traditional media platforms. But the eyeballs have moved on, it is perhaps time OPDP does as well. OPDP has not produced any draft guidance documents in recent months that are relevant to these issues nor has there been much available in the way of enforcement (only four letters issued so far in 2022) to illuminate the many dark areas. The problem is, it is within those areas in which increasing numbers of us reside and consume our information.

To that end, FDA should consider:

  1. Holding another public information gathering meeting on Social and Digital media such as the one held in 2009 to gain further insights into patterns of use and gain a re-focus on the regulatory agenda that results, particularly given the migration of audiences and emergence of new platforms;
  2. Directing more research to discover the important nuances thereto, such as how the ability to scroll before the end of a branded video (where risk information might be) impact perceptions of different types of consumers (FDA is conducting research now into how adolescents perceive risk and benefit) and whether or not impacts on those perception actually presents any greater risk;
  3. Direct attention to the development of additional draft guidance in the 2023 guidance agenda for CDER – it is noticeable that there were no Advertising/Promotional guidance potential guidance documents in the 2022 agenda. Along with the lack of enforcement, this leaves a big gap.

That is a start. We are a long way from knowing how Tik Tok influences health behaviors. But one thing is for sure. Studying DTC on broadcast television isn’t going to get us there and an approach to regulating promotional speech in social media is increasingly not platform agnostic. Just wait till be get to the metaverse. If OPDP is going to stay relevant to its underlying principles and purpose, the agenda needs to move more quickly. Tick. Tock…..

Photo by Solen Feyissa on Unsplash

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