SOCAP International

The FDA's Social-Media Guidelines for the Pharmaceutical Industry

While the industry awaits the final rules, here are five best practices for using social media.

In June 2014, the U.S. Food and Drug Administration (FDA) released a much anticipated second set of social-media guidelines, in follow up to the initial set earlier in the year. Not to anyone’s surprise, the guidelines have already sparked questions and conversations concerning their impact on how pharmaceutical companies can use social media.

The FDA’s Role in Social Media

In fulfilling its primary goal of “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation,” the FDA recognizes that patient safety extends to include safe and effective communications. As such, it’s crucial for the FDA to recognize the full spectrum of communications for today’s consumers and healthcare providers and to fully understand social media and its role in the industry.

Today, social media offers pliant ways for healthcare providers to share information, for consumers to connect with providers and for all parties involved in healthcare to rally around a range of topics— from accountable care, personalized medicine, shared decision making, to emerging trends in diagnoses, treatments and models of care. The FDA appears to have factored these uses into its decision, instead of basing the guidelines on only one category of social-media uses.

However, the agency was and remains in a challenging position—on one hand adhering to its obligation to regulate promotion and marketing, while on the other ensuring patient safety and creating timely regulations and/or recommendations when new forms of communications or changes to social software emerge almost every day.

Pharma’s Opportunities in Social Media

In the past, traditional media followed a sequence as such: a message is delivered via mass communications, awareness is generated and conversations transpire “on the ground” (e.g. general consumer word-of-mouth, patient-physician visits, academic conversations, etc.).

Now consumers have access to technologies and media that give them publishing and interactions platforms to speak their mind and to express their opinions about products and brands. Consumers expect responsive communications from companies to address their needs, answer questions and resolve complaints. In recent years, companies across all industries have recognized this reality and, along their own timelines, have implemented customer-centric solutions to dovetail with their marketing efforts. Although the pharmaceutical industry has regulations that limit its ability to engage with consumers in exactly the same way as consumer goods, there is room for engagement and customer service. What’s required is a working-through or processes and logistics that demand enterprise-wide collaboration.

It’s important for companies to challenge themselves to think of these social media channels, for example Twitter, for uses beyond promotion. Rather than attempt to force-fit the traditional one-way marketing model into social media, pharmaceutical companies should examine existing programs and identify opportunities where the use of social media can extend the benefits of those programs to consumers and healthcare professionals.

Next Steps

The comment period for the guidelines closed mid- September 2014. Pharmaceutical groups have raised concerns that the draft social-media guidelines are not practical and would make them responsible for misinformation that is not directly posted by them and in turn discourage them from interacting with consumers via social media.

Although the FDA has affirmed that the industry should have the ability to correct misinformation, it’s an issue the agency feels very strongly about and it’s likely it will take the industry’s position seriously as it hammers out the final rules.

Best Practices (in the Meantime)

While the industry awaits the final rules, here are five best practices for pharmaceutical companies interested in using social media:

1. Identify clear and specific objectives that lend themselves to social-media outlets.

Activities such as education, customer service and disease-state support valuable conversation. Promotion, on the other hand, may not necessarily spur the most effective types of conversations.

2. Match the social-media platform to the brand’s specific objectives.

Determine how social media can enhance or augment traditional media objectives. Leverage the different characteristics of specific platforms—text versus image versus video.

3. Develop guidelines and workflows for interactions and engagement opportunities.

Structure is crucial for ensuring consistent, re- sponsive and high-quality communications with consumers, caregivers and healthcare professionals.

4. Ensure that qualified staff is on board for all of your social-media activities.

Have social-media specialists who can identify customer service opportunities and follow guidelines on the frontline of interactions. Have workflows that ensure smooth collaboration among all parties. And to avoid missing adverse events and product quality complaints, well-trained staff needs to be involved in the social-media process flow.

5. Work with appropriate vendors.

These vendors must understand customer care and know how to handle all aspects of social media, including adverse event identification, correction of misinformation and patient engagement within the unique parameters of each social-media platform.

Phil Baumann HeadshotPhil Baumann is the social media strategist for Telerx. He is a registered nurse who blogs, consults and speaks about the role of digital and social media in healthcare and pharma. He is also the first clinician to serve on the advisory board of Mayo Clinic Center for Social Media. Bauman is a top 150 Influencer on LinkedIn. You can follow him on Twitter: @PhilBaumann and @HealthIsSocial