Pharmaceutical Social Media Marketing: Risks and Regulatory Issues

The pharmaceutical industry is very interested in using social media to promote products, services and issues important to it.1 However, many drug firm executives are uncertain about how to tackle the legal and regulatory issues associated with social media communications. TNS Media Intelligence/Cymfony and its legal (Seyfarth Shaw, LLP) and strategic marketing (Envision Solutions, LLC) partners have developed this white paper to help the industry:
- Recognize why social media is influencing patients and healthcare providers and how this affects drug firms.
- Comprehend how the FDA currently regulates pharmaceutical marketing. - Understand how drug firms are communicating with patients and providers online in the absence of firm FDA guidance.
- Develop a strategic framework that will help executives understand and manage the regulatory risks associated with social media communications.

The thesis of this paper is that, based on existing principles and precedents in the regulation of direct-to-consumer advertising, marketing, legal and regulatory compliance professionals can have a productive collaboration in helping their companies incorporate emerging social media forms into their promotional mix. Why do we feel this paper is important? According to the Pew Internet & American Life Project, the Internet is transforming healthcare in the United States. Pew reports that nearly 113 million Americans have searched online for health-related information.

To date, pharmaceutical companies have engaged in little social media marketing activity for two reasons:
1. Lack of knowledge. Many drug firm executives are still unaware that healthcare blogs, discussion boards and other patient created content are becoming trusted sources of information for physicians, patients and others.
2. Uncertainty. The Internet has been a major force in healthcare for more than 10 years and the Food and Drug Administration (FDA) has not developed detailed guidance for drug firms seeking to market to patients and physicians on Web sites, in e-mail and in search advertising.

We understand that by publishing this white paper we are stepping into uncharted territory:
- We cannot anticipate how the FDA will regulate the industry’s social media marketing activities. However, we hope the broad principles we present help you successfully handle unfamiliar situations.
- Every pharmaceutical company has its own regulatory culture and may interpret FDA regulations conservatively or liberally. Marketers can build a productive relationship with their internal legal and regulatory colleagues to design social media programs.
- This white paper is not exhaustive. You will very likely encounter situations that fall outside of the scope of this paper. However, we hope the framework we propose helps you successfully handle unfamiliar situations.

But, as the industry’s experience with Internet marketing shows, drug firms can incorporate emerging media into their marketing plans with careful consideration of key factors. While this paper cannot substitute for FDA guidance, it can give marketing, legal and compliance professionals a common understanding of the regulatory environment, examples of how pharmaceutical companies are moving ahead with social media initiatives and a framework for discussing the elements of their own company’s social media programs.

Part I: Social Media, Healthcare and the Pharmaceutical Industry
With 113 million Americans relying on the Internet to find health information, it is clear that Dr. Google and Nurse Yahoo! have become critical components of the nation’s healthcare system.4 Consumers are going online to find information about the latest health scare, their children’s sniffles or chronic disease management. Physicians are relying on search engines to help them diagnose rare illnesses. Also, clinical researchers are using online patient communities to recruit patients for clinical trials. However, some are concerned that the Internet is doing more harm than good. For example, in 2006, the Pew Internet & American Life Project reported that most Americans are not practicing due diligence when they are searching for health information on the Web. 5 Pew found that “most Americans start at a general search engine when researching health and medical advice online.”