Marketing pros salivate at the idea of using Facebook, Twitter, Google Plus and similar tools to bolster brands and promote the gamut of medical devices and drugs. But enthusiasm is the last thing compliance officers feel when they survey this new frontier. From the standpoint of risk-management, after all, there is not much to “like” about the unknowns still associated with social-media use by pharmaceutical and medical-device companies. But should the industry simply desist from using social media to communicate with consumers and healthcare professionals? Certainly not. With respect to compliance, a few “bright lines” can be gleaned from FDA warning letters, draft documents and other resources. And when it comes to those problematic “shades of gray,” it is quite possible to chart a course that leverages the benefits of social media while minimizing the risks.
It helps to keep those risks in perspective. While enforcement has been inconsistent, the FDA has hardly launched an all-out attack on the use of social media by drug and device companies. One particular warning letter, which made headlines in 2010 after regulators ran across a “Facebook Share” widget on the U.S. site for the Novartis drug Tasigna, is often cited as grounds for concern. The widget in question enabled users to pass along company-generated content about the drug to their social-media pals. But space constraints meant the online message could not include the interminable risk information that is part and parcel of any drug ad. Regulators attacked the omission as misleading and said it created the false impression that Tasigna was better than other products. They accused Novartis of violating the Federal Food, Drug and Cosmetic Act, along with related regulations.
But the Novartis letter represents the exception, not the rule. One could argue that all has been (mostly) quiet on the social-media regulatory enforcement front. And yet, given the atmosphere of uncertainty in this area, it is understandable that drug and device companies continue to be circumspect about their use of social media. Even the FDA’s draft guidance relating to unsolicited, off-label claims has been criticized for its failure to address key issues, and the industry will not have a more comprehensive set of guidelines until the final guidance comes out in July 2014.
In spite of this regulatory limbo, some drug and device companies have made strides in adjusting to the realities of online media. AstraZeneca’s recommendations to FDA happen to double quite well as a description of the kinds of broad objectives that companies should keep in mind as they steer their social-media efforts. Here is a paraphrased summary:
1. Truth and accuracy: Any social-media content put forth by drug and device companies should be truthful, balanced and accurate, with no misleading omissions.
2. Respect of others’ interests: In such communications, the interests of patients, caregivers and healthcare professionals should be treated as sacrosanct—especially when it comes to matters of privacy and the relationship between doctors and patients.
3. Patient health: The goal of social-media communications should be to improve people’s access to quality information, which they can use with their doctor to improve their health.
4. Transparency: Any product-sponsored messages should be transparent, so that all who see them immediately understand the sponsor‘s role in the online discussion.
5. Respect of others’ opinions: Online forums can be hotbeds of hostility. In their social-media efforts, drug and device companies should respect the opinions of patients, caregivers, clinicians and others. Ultimately, trying to censor or limit other people’s views is counterproductive.
The priorities above were formulated by an internal team that AstraZeneca put together to tackle social media issues from A to Z. Companies that have not yet taken this step ought to consider doing so. The team can take a look at the growing number of resources available to the industry—not just FDA warning letters and draft guidance documents, but also “crowd-sourced” information drawn directly from peers. Recognized by the World Health Organization and top-tier universities alike, the website Webicina is one such example. This free resource is the brainchild of blogger, medical futurist and physician Dr. Bertalan Mesko. It seeks to give patients and medical professionals “a meaningful and secure use of the Internet” by highlighting innovative approaches to social media, and by culling information and perspectives on dozens of specific topics. Its “Open Access Social Media Guide for Pharma”—a free PDF file, with 2.0 now in the works—contains excellent advice on how drug companies should use Twitter, Facebook, Wikipedia, YouTube and blogs. It also offers specific “rules of engagement” for both pharma and physicians.
Also potentially instructive are the guidelines published by Britain’s Prescription Medicines Code of Practice Authority, which aim to help the U.K. industry use social media legally and responsibly, up to and including tips on handling product complaints and adverse events. Certainly, FDA’s forthcoming guidance will differ here and there from the U.K. document, but the latter’s recommendations on the likes of privacy, training, project management and oversight, proper declaration of company involvement and more are quite useful. The document highlights three broad categories of social media activities: “listening in” on social media conversations, “giving out” information via such channels and “engaging with” online audiences.
According to the U.K. guidance, British drug and device companies have an obligation to collect information and follow-up on adverse events and product complaints that emerge online, regardless of:
• The seriousness of the event
• Whether the reporter is identifiable
• Whether any adverse events are listed in the product’s formal description
• Whether a definite causal relationship or link to the product has been stated
• Whether the stakeholder or patient has already reported the event to the competent authority or claims to have reported it to the company.
Drug and device makers already maintain robust staffs of online monitors, and guidelines like these illustrate how the need for this will likely grow and expand. And because anyone, anywhere, can chime in via social media, it is critical that companies have a coherent policy that is thoroughly understood by drug reps, agents and employees at all levels. Precisely who can use social media on behalf of the company—and exactly the types of things that can and cannot be said—must not be left to chance. When it comes to social media, everyone in the company must be on the same webpage, so to speak.
But even for companies with best-in-class policies and procedures, vexing scenarios might emerge. These days, some of the most popular podcasts deal with health and medicine. Typically, podcasters are in constant dialog with their Facebook and Twitter followers, and they often have their own web forums as well. Some of the bigger podcasters might have hundreds of thousands of listeners and followers. Let’s say Joe Podcaster is on the air. “Even though Drug X is for colds, we gave it to our daughter because we heard it would help her eczema,” he says. “But now she had a terrible headache and feels nauseated. Has anyone else experienced this?”
In response, dozens of Joe Podcaster’s followers report their own anecdotal experiences with the drug—on Facebook, Twitter, his blog and possibly elsewhere. Some say the drug helped with eczema; others report various adverse effects. Now the company must decide what to do. And because podcasts “live forever”—each day, people download and listen to podcasts recorded months or years ago, posting comments about them as well—there is the potential for huge accumulations of adverse events and product complaints online. Based on what FDA has said thus far, it seems likely that in many cases this response information will have to be communicated privately, not by sales and marketing staffs but instead from the company’s version of “Marcus Welby.” Tools already exist to help with online monitoring—everything from pricey software to the likes of Google Tracking—but response compliance is a potentially unwieldy challenge. To be sure, company-authorized responders must be highly trained, with clarity and unity of message at all times. The good news is that, at least so far, true adverse events triggered by online conversations appear to be rare.
Despite the uncertainties and potential headaches involved, engaging with the public via social media is the right course of action for drug and device companies. Arguably, many companies could do more on this front. After all, doing so allows them to be proactive about the benefits and risks of their products. This can go a long way toward building trust with consumers. And while battling myths and misstatements in the wilds of the Internet is not easy, one could argue that the industry has no other choice. Twitter, Facebook and the like are now inseparable from our national conversation on public health. And that conversation, including its complex iterations online, is simply too important for the industry’s voice to be absent or drowned out by the opinions of the uninformed.
Patrick J. Hurd is a Veteran healthcare attorney and a Senior Counsel in the Norfolk, Va., and Washington D.C. offices of national law firm LeClairRyan. He can be contacted at:firstname.lastname@example.org