The parameters governing pharma promotional speech in digital and social media have struggled to keep pace with the rapidly evolving healthcare communications landscape. How can FDA play catch-up in advancing an agenda more reflective of industry and patient needs?
There was a time not very long ago when the average patient received the bulk of information about his or her condition while sitting in the doctor’s office. There might have been pharmaceutical company brochures in the waiting area or charts on the wall. The patient may have read about a new treatment recently approved by FDA in a newspaper that appeared at the end of the driveway each morning, or they may have seen a medicine advertised while watching the evening news on television that would be brought up when seen by the doctor. Communication was largely one-dimensional. The bulk of the information exchange would occur in the exam room between the doctor and the patient. Those days are, of course, long gone.
With the advent of the internet came the familiar Dr. Google followed by social media platforms where news was delivered all day and all night from a huge variety of sources, including healthcare information. People could personalize their sources, share it, and even participate in commentary on it. The entire way we communicate changed, becoming not only multidimensional but highly personalized and curated. People transitioned from being passive recipients of healthcare information to more dynamic partners. The old days were left far behind. We changed. Unfortunately, FDA has not.
Early adopters of digital and social platforms were primarily the young—using Facebook, Twitter, and blogs to share personal information and activities at the time. It did not take long for the institutional use of these platforms to take root, especially as marketers realized the potential. With promotional speech highly regulated by FDA’s Division of Drug Marketing, Advertising, and Communications—known today as the Office of Prescription Drug Promotion (OPDP)—the industry was among the last to embrace social media. Some said they would never even attempt it. The participatory nature of social media, the space limitations, and a whole host of other issues begged new questions about the rules that required answers. Without answers, there was a perception of high risk associated with wading into this new space. Consequently, pharma was among the last of institutional users of these platforms.
At social media’s infancy, FDA’s approach to the regulation of digital and social media could be summed up in seven words: “It’s not the medium, it’s the message.” In other words, the agency, like many others, underestimated the potential of these platforms and saw no reason to offer new insights into the agency’s regulatory approach. Even in the regulatory void, the increasing migration by patients to digital left little choice but for the pharmaceutical industry to follow. Before long, some companies opened dozens of Facebook pages, Twitter feeds, and Instagram accounts, both branded and unbranded. Even FDA, itself, came late to the game and developed a wide range of social media assets, which was a tacit acknowledgment of the fact that health-seeking behaviors and communications had undergone a dramatic shift.
FDA’s enforcement over promotional speech in those days had been much more robust than by today’s standard. The agency issued a healthy number of warning and untitled letters each year. In 1998 alone, FDA issued more than 12 letters each month. By contrast, in 2021, the agency sent out only six letters for the entire year and was on track for an even smaller number in 2022.1
To add to the uncertainty of the regulatory environment, in April 2009, the agency engaged in an extraordinary enforcement action—issuing 14 untitled letters that covered 45 different brands for a violation on a digital platform over a single day.2 This seemed to be a repudiation of the earlier stated position that, “It was the message, not the medium.” The action was directed entirely at a specific medium: the banner advertisement.
Until that action, there had been a widespread understanding among the industry that risk information could be adequately conveyed by a reference where there was a limitation in space. In other words, presenting the name of a drug and its indication with a link that took an Internet user to a page that included risk information was within regulatory parameters. It was commonly referred to as the “one-click rule.”
The problem, of course, was that it wasn’t a rule at all. It was merely a common practice and, as such, was perceived as an accepted practice. In fact, it was (and is) one that FDA regarded as violative and acted to underscore the point, dramatically demonstrating the impact a lack of regulatory guidance can have. A few days later, The New York Times carried a story about the action with the headline “FDA Rules on Drug Ads Sow Confusion as Applied to the Web.”3
This spelled the need for clarity. Later in 2009, FDA signaled an openness to reconsider the dogma of the “it’s not the medium, it’s the message” perspective, announcing a two-day Part 15 meeting in Washington, D.C. to gain stakeholder input on the agency’s approach to regulating speech in digital and social media.4 The agency posed five questions as the basis for the discussion. It was presumed by many it would offer the framework for eventual guidance from the agency. The agenda covered the topics of (1) determining ultimate responsibility for communications within social media operations; (2) communications in venues where there are space limitations; (3) correcting misinformation posted by third parties; (4) the appropriate use of links; and (5) questions specific to adverse event reporting.
While there had been widespread hope that a single guidance document would shortly result, it was almost five years later that FDA issued two primary draft guidance documents. The first addressed communications in a venue where there are character space limitations, specifically on presenting risk and benefit information in that context. The second was on correcting third-party misinformation, which provided a great deal of clarity related to the issue of responsibility for communications.
Since that time, digital platforms have come and gone. The widespread use of smartphones has expanded access exponentially. The social media assets of all the stakeholders have proliferated, both branded and unbranded. At the same time, enforcement has plummeted. Health-seeking behaviors, particularly during the COVID-19 pandemic, highlight not only the need for information but the need for accurate information to counterbalance a stream of misinformation. In short, the role of the internet and social media has grown considerably while the traditional forms of communication have correspondingly diminished. By contrast, traditional platforms like commercial television, where direct-to-consumer (DTC) advertisements might have once been a primary source of information, diminish as increasing numbers of households have cut the cord and rely instead on select internet communications.
At the same time, new platforms continue to emerge. TikTok—a short-form video hosting platform—has become one of the latest means by which pharmaceutical companies engage with digital audiences. How do branded communications in that kind of environment work? What are the rules? What are the parameters?
In short, the dynamism of change in the communications environment demands a similarly balanced dynamism in providing the regulatory parameters in which the industry is operating. Without it, we return to the “one-click rule” days where there are norms operating without established guidance.
In developing social media guidance, the agency avoided discussion of specific platforms, sticking instead to enunciating agency principles in delivering fair balance—for example, where there are operational challenges. Does FDA need to provide insight into TikTok since it has emerged in prominence? Probably not. But it would seem desirable for the agency to develop a perspective of how the dynamics of that communications environment (i.e., short-form videos) might be treated by FDA. Given the rapid changes in the digital environment—where platforms have come and gone sometimes with astonishing speed—being platform-agnostic made sense. But it also leaves a good deal to interpretation.
Short-form videos aside, another pressing issue is in relation to the optimization of a website for mobile device viewing. For large swaths of people, access to information on the internet is not via computer but rather via a mobile device (i.e., a smartphone where the view of a website is a far different viewing experience than on one’s desktop screen).
The draft guidance document on operating under space limitation is insufficient on issues relating to the presentation of risk information for both short-form videos and website optimization. Rather, the agency appears to be relying on stakeholders in the industry to consider its past direction. As such, the industry is left to read the tea leaves.
Where might those be found? There are three primary means to discern FDA’s regulatory outlook. The first is obviously through the issuance of guidance documents. As mentioned, to date, there have been only two documents that, taken together, address the bulk but not the entirety of the questions posed as the framework of the Part 15 meeting discussion.5 There is still a lot that is lacking, particularly regarding the use of links.
The second means of providing the industry with direction is through enforcement patterns. But as noted, enforcement has not only slowed to a trickle, out of the over 350 letters issued by the agency since 2004, there has been only scant enforcement related to social media.6 There have been a few letters involving YouTube, three that were related to Facebook, and two regarding Instagram.6 There have been none involving Twitter. That said, within the past few years, there appears a slightly increased scrutiny of digital communications. Of the 10 letters issued in 2021 and 2022, FDA has twice cited banner ads, one sponsored link, and one Instagram post. In other words, enforcement has involved digital/social communications platforms 40% of the time.6 The fact that banner ads and sponsored links still appear the subject of regulatory action letters signals that the agency is unchanged regarding the incorporation of risk information by reference. That leaves the appropriate use of links question raised in the original Part 15 framework without further clarification.7
The third insight into regulatory intent is looking to subject matter that is the focus of OPDP’s research efforts. But very little of the research has been focused on outstanding social and digital questions. Rather, there continues to be a focus on DTC advertising. One exception was a 2017 analysis of how branded prescription drug promotion delivered risk and benefit information on mobile platforms.8 The study concluded that, while risk and benefit were being presented in the mobile presentation, the information was “not equally prominent and accessible.” An earlier study in 2016 examined the placement of risk information in DTC websites, without specifying mobile.9 That defines the issue but not the solution. What presentation of risk information in this setting is the most effective? How do people interpret what they see? How does what they see influence their perceptions? The current research underway does not appear designed to provide answers. In looking at planned research, there is little or nothing to indicate further illumination on digital or social communications generally or on the question of optimization for mobile specifically.
The information gleaned from the April 2009 Part 15 meeting is outdated. Since that time there has been an a huge increase in digital information-seeking behaviors and a proliferation of assets by medical stakeholders. Additionally, there has been a tidal wave of misinformation. The development of two guidance documents by FDA in the span of the near decade and a half since the Part 15 meeting is insufficient. The dynamic communications environment demands a much more robust system for evaluating the emergent needs and demands not only in the best interests of the pharmaceutical industry but in the best interest of the patients who rely upon them. Regulatory surprise packages in the form of enforcement, such as that in 2009, are insufficient. A research agenda that is not laser-focused on how and where people are talking about medicine does not advance the agenda in a meaningful way.
FDA needs support from a mechanism that could provide speedier input and responses to change, much like the agency already manages advisory committees to help provide input into the approval of new drugs, devices, and vaccines. A communications advisory committee could provide the agency with a nimbler means of addressing change and implementing regulatory policy changes in a rapidly evolving communications environment as well as inform OPDP’s research agenda.
In addition, FDA should consider holding another Part 15 meeting to gain a perspective that is more in touch with what is happening on the ground on the part of both the pharmaceutical industry and the patients who rely upon them.
Finally, the agency needs to implement a research agenda more reflective of the actual need. It has become clear with the growth of digital and social media, and the heavier reliance on these platforms for health-seeking behaviors, that the medium does matter. The nuances of language and practice in more traditional communications that reflect the current research agenda are important, but it is equally important to understand how fundamentally the world has changed. Without that sort of attention, pharmaceutical communicators are forced to return to the days of the “one-click rule” when the regulated industry must interpret for itself without guidance from the agency that is doing the regulating.
Mark S. Senak is the senior vice president and partner of FleishmanHillard and an author of the blog, Eye, on FDA.