Legal and regulatory risk associated with Web 2.0 adoption by pharmaceutical companies

Web 2.0 applications and tools include blogs, podcasts, wikis and social networking communities. These tools, especially blogs and wikis, have been rapidly adopted by internet-savvy patients as a source of information and discourse about medical conditions and treatment options. Information via these applications has had an impact on patients' choices about their healthcare. In response, opportunities with Web 2.0 have been explored by pharmaceutical companies and medical institutions. These companies believe that Web 2.0 and Patient 2.0 tools offer an innovative way to connect with physicians and patients. Additionally, Web 2.0 can be a new method for marketing to consumers in an era where the return on investment is falling with more traditional channels. Neither the Food and Drug Administration nor Federal Trade Commission (FTC), however, has released firm guidance for Web 2.0 communications. Therefore, pharmaceutical companies are reticent regarding adoption of Web 2.0 for fear of a poor risk-benefit ratio and a lack of documented success with these tools. There are two primary concerns voiced when marketing via Web 2.0: off-label promotion and adverse event reporting. This paper provides an overview of Web 2.0, details associated regulatory risks and illustrates select strategies to help navigate these largely unexplored, but potentially powerful mechanisms to reach prescribers and patients.