Dale Cooke, Digitas Health

Fig. 1. Pfizer’s decision tree for handling online comments. Credit: Pfizer

		The regulatory challenges associated with using social media by the makers of prescription products have received ample discussion. In 2009, FDA held two days of hearings on using the Internet and social media, and since then speculation about guidance from the FDA has been frequent. Lost in this discussion, however, is that most of the regulatory issues are well understood. Making claims about a product’s benefits requires providing appropriate risk information to ensure that the claim is balanced regardless of where the claim is made—be it on Twitter, YouTube, a television commercial, or a print ad. Using the brand name requires the use of the generic name with no intervening matter, regardless of how long the brand name or generic names are or how space-limited the context. There certainly are issues that additional FDA guidance could address, but no further FDA guidance is likely to change these and other basic parameters.

		Instead of spending time debating these requirements, responsible marketers of prescription products need to move on to the other challenges associated with social media: the operational issues. Though frequently conflated with the regulatory issues, these separate obstacles force marketers to sit down and determine how to make a social media plan into a marketing communications reality.

		What are the operational challenges of social media? Three lead the list:

		Adverse event reporting has long been a source of concern for marketers using social media. Some feared that venturing into social media would uncover a large number of previously unknown AEs, and that instead of actively supporting a brand, social media efforts would turn into nothing more than AE reporting efforts. A few high-profile studies by marketing firms claimed to demonstrate that these fears were overwrought. One such study claimed that fewer than one percent of social media posts mentioning a product constituted a reportable AE.

		The actual experience of marketers engaged in social media has been somewhere in the middle. The incidence of AEs in social media has been far greater than some social media marketing firms predicted, but companies actively engaged in social media have not been overwhelmed. No company has yet withdrawn a social media initiative because of an excessive volume of adverse event reports, and the lessons they have learned can benefit anyone launching a new social media effort.

		When initially developing a social media initiative, AE reporting has to be brought into the mix early. First, make sure the AE reporting team and the call center are aware of the new efforts before they go live. No one in that important operation should be blind-sided by unexpected reports from an unknown venue. Second, review the current AE reporting procedures in light of the new initiative and examine what changes (if any) are needed. For example, does the form for submitting an AE report include a field for URL where a Tweet, Facebook post, or other mention can be found? Is there a process in place for following up with people who are known only by their Twitter handle or other online alias? By addressing these questions while designing the social media initiative, the eventual rollout will go much smoother.

		The second and the third issues are closely connected. Expectations in social media are not set primarily by the makers of prescription products. The expectations for how any company regardless of industry will engage socially are being set by Comcast, Delta, General Motors, American Express, and other highly social enterprises. A consumer who mentions a delayed flight on their Twitter feed has become accustomed to receiving a response from the airline in minutes, and consumers expect the same from companies that make pharmaceuticals and other prescription products.

		That level of responsiveness can be difficult, and the idea of generating a custom response to a social media post can seem daunting. Just getting the response through the medical-legal-regulatory promotional materials review process can take several days (or weeks), and when a product is discussed, the response has to be sent to the FDA before use.

		But marketers already know how to deal with these challenges in their non-social media activity. Many of those interactions are scripted with a variety of appropriate responses approved and submitted to FDA well in advance. The first step is to develop a decision tree for the particular social media effort. Fig. 1 is an image of the decision tree that Pfizer developed, based on one originally created by the Air Force for determining how to react to bloggers.

		To make an effective decision tree, marketers have to think through the most likely scenarios. Did the social media post from another person mention a product? What was the tone of the response? Is the post from a known person? The specific possibilities and possible outcomes will vary depending on the initiative, but the broad pathways are fairly easy to identify.

		Some possible pathways have to be included in any social media decision tree:

		2. What if an adverse event is reported?

		3. What if a post concerns off-label information?

		4. What if incorrect information is posted?

		5. What if the post is not addressed by an existing response?

		For each path, the person using the tree has to be provided criteria for determining what action to take. The primary decision is whether to respond at all. If a response is warranted, then several responses should be developed in advance. It is important to develop multiple variations in the same vein to allow the responders to use the one that fits the situation with the appropriate tone. For example, in response to incorrect information, the appropriate response might be something along the lines of, “The correct prescribing information for Brand X (Generic Name Y) is available at link.com” or “The complete directions for correct use of Brand X (Generic Name Y) are available here: link.com.” Responses along those lines can be written well in advance, and that assists in tackling the issue of FDA filing requirements.

		Responses that include a product mention have to be submitted to FDA prior to use; however, once submitted the responses can be reused repeatedly without requiring a new FDA filing for each use. That makes it possible to create and submit multiple responses for any given situation to the FDA before the initiative launches.

		Regarding the issue of responding to requests for off-label information, FDA has already provided guidance on the procedure it recommends, and sponsor companies can review that guidance in developing that response pathway.

		When developing a social media forum (such as a Facebook page owned and maintained by the sponsor company), instead of participating in pre-existing forums, there is an additional consideration: setting the ground rules for appropriate interactions. Here again, it’s possible to learn from those who have gone first.

		Boehringer Ingelheim’s Facebook page* presents a very good example of an effective description of the limitations for discussions. Among other things, BI’s Facebook page makes it clear that this setting is not appropriate for product discussions. Establishing that up front makes users more receptive when one of their comments is deleted or is taken off-line because it addresses a product.

		The terms for a forum also provide an opportunity to set the expectation that in some cases it might take more time to respond. Having a response available for the important fifth category mentioned above (when a post is not addressed by existing responses) is extremely important. The message can be simple, along the lines of, “Thank you for your post. We will need time to respond appropriately and will reach out when your response is available.”

		By thinking through the pathways in advance, the need for this response can be minimized, though probably not eliminated. And, of course, each time this response is used, it presents an opportunity to revisit the pathways in the decision tree. Is this instance genuinely a one-off occasion or is this likely to happen again? If it is likely to happen again, then the decision tree should be revised to include this possibility and the response that was used should be made available for the future.

		Making use of these techniques enables marketers to overcome the operational barriers to social media usage. Social media involves an ongoing commitment to engage with people in the media they prefer. Doing so compliantly means tackling the operational as well as the regulatory challenges, and there are techniques for addressing those operational challenges.

		Dale Cooke is the head of Regulatory for Digitas Health (www.DigitasHealth.com), a healthcare marketing firm purpose-built to connect today’s healthcare brands with 21st century healthcare consumers and professionals.

Dale Cooke, Digitas Health

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