MDD Perspectives Contributing Writer

Editor's Note: Dr. Mark DeWyngaert, with Huron Consulting Group, provides operational, clinical, managerial, consulting and litigation services to various segments of the life sciences and healthcare industries. He specializes in assisting pharmaceutical manufacturers, biotechnology and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property. Huron's Life Sciences Advisory Practice assists medical device and biopharmaceutical firms with addressing compliance and business challenges associated with the use of social media.

Over the last several years, the amount of user-generated content on the Internet has increased dramatically – both in sheer quantity and in variety of available formats. Traditionally, material on the Internet was produced only by those entities with access to the necessary web design tools and services.

Today, it is simple and common for individuals to post pictures, videos, product reviews, and personal or political commentary on the Internet. This transition has been enabled by a number of new social media technologies and tools, and today roughly 60% of Americans engage in social media platforms, including sites such as Facebook, LinkedIn, YouTube and Twitter. Collectively, these and other technologies have promoted and enabled what is popularly known as Web 2.0.

Social media outlets present the opportunity to express thoughts, ideas and opinions; this opportunity is offered not just to individuals, but also to corporations. The presence of social media is visible in nearly every industry; public and private sector organizations alike commonly embrace and leverage at least one of many social media tools via blogs, Twitter, podcasts, video sharing or other means.

Applications within the medical device and biopharmaceutical industries
Many companies within the medical device, biotechnology and pharmaceutical industries have established a formal presence on various social media websites. These sites have been used to communicate information about new products, opinions on various government initiatives, and general disease state information.

In general, Web 2.0 social media technologies offer life sciences companies new and innovative methods to promote their products and interact with consumers.

While Web 2.0 offers many opportunities for life sciences companies to improve their relationships with consumers, the companies must act in accordance with all FDA, FTC and other relevant guidelines in order to ensure that any communications or other promotional messages are in compliance with state and federal legislation.

The current regulatory environment for social media sites
In 2009, the FDA warned 14 major pharmaceutical firms about brief Internet advertisements that could have misled patients because they did not include information about health risks related to the promoted drugs. However, the FDA has not yet issued specific guidance regarding medical device, biotechnology and pharmaceutical company usage of social media technologies.

A public hearing on this matter was held in 2009. At the hearing, representatives from medical device and biopharma companies – along with patients, concerned citizens and representatives from industry trade groups, periodicals and social media sites – discussed their usage of and concerns related to social media sites.

In general, participants agreed that increased guidance from the FDA was necessary; however, concrete guidance on this matter will undoubtedly not follow for months or years. Until the FDA has issued formal guidance, companies would be prudent to exercise the same level of caution in all content they publish via social media sites as they would with content published via traditional means.

Establishing a control system for company-initiated social media content
Life sciences companies may wish to develop social media content in order to garner greater patient collaboration, promote brand awareness among an informed audience and to provide a forum to further measure consumer attitudes and behaviors. Without engaging in open dialogue with the community, companies may risk the loss of public credibility, particularly in the face of competitors who have a coordinated focus with consumers on the Web. Although social media technology may offer the possibility of many benefits, the regulatory environment in which life sciences companies operate mandates that executives address serious concerns and challenges involved with social media.

In order to mitigate the risks associated with undertaking such an initiative, a company must first understand exactly what types of media are being produced (e.g., pictures, videos, tweets, etc.), what type of information is being discussed in each of these media, and who is producing the information (e.g., employees, patients, consultants, etc.). Companies should then identify, in light of FDA/FTC regulations and guidance, the specific liabilities associated with each type of content. In order to protect the image and best interests of the company when facing these risks, each company should consider proactively creating a common companywide policy surrounding the internal use of social media technology. Clear written guidelines must be developed which should consider the points provided above.

By developing a comprehensive set of policies and procedures related to company-initiated social media content, companies will be able to better control risk that might result from promotional activities through these media.

Risks and opportunities for life science companies
Web 2.0 and the associated explosion of user-generated content on the Internet present a variety of opportunities and risks for life sciences companies. These new methods for distributing information allow companies to educate the public, connect with consumers in the most up-to-date manner, and distribute promotional and disease-state information in "real-time."

With these opportunities come new risks: Companies must continually be vigilant for the posting of unauthorized material, material which has not been properly reviewed through the company's social media material review process, or material that could be considered off-label promotion or potentially requiring adverse event reporting. Companies also must address the potential volume of information shared on various social media sites with the ability to process that information in a continuous and timely manner for state, federal and international regulatory compliance purposes.

Ultimately, these risks must not be viewed as simply compliance risks, but also as business risks – as content posted by dissatisfied customers may reach millions of additional potential customers and sway their opinion of a company or product. Indeed, a search on Twitter for popular drug brand names will reveal posts from numerous users, and many posts contain adverse event information related to usage of that drug. The industry as a whole must consider how to respond to such information so that its reputation is not adversely affected.