Facebook widgets are being blamed for computer viruses, personal data theft and now health dangers. The Food & Drug Administration told Novartis in an August 2010 letter that its widget for the leukemia drug Tasigna violated FDA advertising rules in part because the widget lacked information about potential health dangers. In response, the drug maker pulled the widget, which allowed Facebook users to share their experiences with the drug.
At first blush, it appears that terrestrial rules do apply to the virtual world, no matter what new media marketing gurus say. At the most basic level, the FDA said in its letter that Novartis ran afoul of agency rules:
The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products.
At a higher level, the FDA said that the widget needed to be approved, though that raises several questions. While Novartis might resolve issues regarding risks and claims with proper disclaimer language embedded in the widget, it would be more difficult, given the unstructured nature of social media, to control comments that run off its pages. Again, the FDA letter:
FDA regulations require companies to submit specimens of any labeling or advertising devised for promotion of a drug product approved under Subpart H regulations at least 30 days prior to the intended time of initial dissemination per 21 CFR 314.550. Moreover, FDA regulations require companies to submit specimens of any labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product.
At the highest level, how could Novartis submit in its application user comments — not yet written — that might be construed as testimonials? The drug maker could control comments on its Facebook page for Tasigna, but how would the company remove violations that appear on users’ pages as a result of a widget? And what can Novartis do about the community page for Tasigna, whose creator is unknown?
The FDA is struggling with the same questions and will likely continue to do so as long as innovations in communications outpace efforts to control speech about products. For now, the only answer may be to hire a lawyer who understands how old-world rules and new-world anarchy can be made to co-exist.
