Kellie B. Combs
October 29, 2010 (Vol. 19 No. 26)
In recent years, the promotion and marketing of pharmaceutical products has been affected not only by the advent of direct-to-consumer advertising, but also by the proliferation of social networking and other online media tools such as blog posts, message boards, chat rooms, Facebook, and Twitter. Pharmaceutical companies have never before had such a direct link to users and potential users of its products. Equally important, these consumers have the means to communicate with each other about their experiences. The U.S. Food and Drug Administration's ("FDA") advertising and promotion regulations barely scratch the surface of the issues implicated by these new forms of communication, and despite industry pleas, the Agency has yet to issue formal guidance in this area.
Nevertheless, FDA continues to regulate piecemeal by issuing letters to companies it concludes have violated the law by promoting their products through these avenues. This LEGAL OPINION LETTER discusses the letter FDA recently issued to Novartis regarding its use of a "Facebook Share" widget, the lessons that letter contains for other companies wishing to promote their products online, and the need for FDA to issue concrete guidelines.
On July 29, 2010, FDA's Division of Drug Marketing, Advertising, and Communication ("DDMAC") issued an "untitled letter" to Novartis regarding the company's promotion of Tasigna®. The drug, which is approved for second-line treatment of chronic or accelerated Philadelphia chromosome positive ("Ph+") chronic myelogenous leukemia ("CML"), is also associated with several serious risks, including QT prolongation and sudden deaths, severe myelosuppression, elevated serum lipase, liver function abnormalities, electrolyte abnormalities, and hepatic impairment. To mitigate these risks, Tasigna is subject both to a Boxed Warning and to a Risk Evaluation and Mitigation Strategy ("REMS"), which requires the education of physicians and patients with regard to drug risks and proper dosing strategies.
In the letter, DDMAC took issue with a feature on the Tasigna website--a Facebook Share widget that allowed website visitors to post Tasigna information on their Facebook profiles and to share that information with fellow Facebook users. Specifically, the widget displayed Novartis-created Tasigna content such as graphics, website links, and short descriptions of the linked sites, known collectively as "shared content." According to DDMAC, the widget misbranded Tasigna by:
-- Omitting risk information. The shared content did not explicitly disclose risk information for Tasigna and instead directed users to click on links to Tasigna websites that contained the full risk profile for the product. DDMAC asserted that the hyperlinking was insufficient and that, to be truthful and non-misleading, promotional materials must contain risk information in each part to offset claims about the drug--especially where, as here, the product was subject to a Boxed Warning and REMS.
-- Broadening the indication. The shared content referred to "Ph+ CML" and affected patients, which DDMAC interpreted as applying to all patients with the disease. DDMAC emphasized that the product's indication at the time was limited to patients with chronic or accelerated cases and was approved for second-line treatment only. Additionally, the letter stated that the widget should have included information about other limitations to Tasigna's use, such as a statement that its effectiveness was based on hematological and cytogenic response rates and that clinical data showed no improvement of symptoms or survival benefit.
-- Making an unsubstantiated superiority claim. The shared content classified Tasigna as a "next generation" treatment even though no clinical data existed to demonstrate its superiority over other products in the class.
Importantly, the Novartis letter indicates that despite FDA's failure to issue Internet and social networking guidance, it will not refrain from penalizing companies for what it determines to be inappropriate promotion using these forms of media. The three issues cited in the letter--omission of risk information, broadening of indication, and unsubstantiated superiority claims--are consistent with the truthful, non-misleading, and fair balanced tenets of drug advertising and promotion and are not, of course, specific to promotion on the Internet and through social networking. What is unique here are the limitations on the media form itself. The Facebook Share widget is, by design, limited to website links and brief descriptions. If, as FDA implies in the Novartis letter, risk information and caveats with regard to a product's effectiveness must accompany each product claim in side-by-side fashion, the use of widgets for drug promotion will be foreclosed altogether. The same is true for other space-limited social media tools; Twitter, for example, with its 140-character limit, would certainly not be conducive to the detailed communication of safety and risk information FDA demands. Because it has regulated by letter rather than rules or guidance, however, the implications of DDMAC's statements are not entirely clear. Would, for example, DDMAC apply the same level of scrutiny to the promotion of a drug that was not subject to a Boxed Warning or REMS? Or would it allow some form of abbreviated risk information with a reference to the complete prescribing information? Only time will tell.
The industry has been waiting for Internet-specific FDA guidance or regulations for years. Indeed, FDA held its first public meeting on the subject in 1996, yet never formally addressed the concerns raised at the meeting. Similarly, while many believed it was long overdue, FDA held its first public meeting regarding social networking tools just last year. These forms of media, unlike traditional drug advertising and labeling, pose a host of complicated problems in addition to the Facebook Share issues discussed above, including the anonymous, "public" nature of comments in chat rooms and message boards; the different characteristics of sites and tools (e.g., Wikipedia, Facebook, Twitter, YouTube); the difficulty of monitoring real-time communication; the sheer volume of possible communication outlets and third-party posts; and the global nature of sites and tools. Therefore, even if it were possible to glean straightforward rules from the Novartis letter, those principles may not translate to other forms of media. Even if they did, they still would not be comprehensive enough to guide companies in their design of promotional strategies and attempts to comply with the law. Promotion on the Internet and through social networking tools represents a valuable opportunity for companies to share information about their products and for consumers to connect with each other to learn about actual treatment experiences. FDA should issue guidance in this area not only to provide companies with certainty as they develop their advertising strategies, but also to ensure that the information available to consumers is truthful, non-misleading, and fairly balanced, regardless of the form of media used to convey the message.
Kellie B. Combs is an associate in the Washington, D.C. office of Ropes & Gray, where she is a member of the firm's Life Sciences Practice Group.