FDA has again made clear its interest in ensuring that “less traditional” forms of marketing of FDA-regulated products do not mislead consumers or otherwise pose a potential risk to public health. Back in November 2009, FDA held a public hearing and opened a docket on promotion of medical products using the Internet and social media tools, such as Google searches, Twitter, Facebook, and Wikipedia. This hearing alerted companies to increased FDA scrutiny of, among other things, company-sponsored websites and third-party websites that may be receiving manufacturer grants or other funding.
On April 21, 2010, FDA’s Division of Drug marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Novartis Pharmaceuticals Corporation concerning two disease awareness sites sponsored by Novartis, www.gistalliance.com and www.cmlalliance.com -- even though these websites nowhere mentioned the Novartis cancer drug by name, Gleevec®. FDA nonetheless considered these websites to be “branded promotional materials for Gleevec” that promoted the drug for an unapproved use, failed to disclose risk information, and made unsubstantiated dosing claims that could “put patients at higher risk of experiencing serious adverse events.”
FDA did some detective work in linking the two disease awareness sites to Gleevec. Among other alleged connections, FDA found that the two websites were:
- “perceptually similar” to the Novartis Gleevec product site” in that both included a “distinct orange” color scheme and similar design layouts, for example;
- registered to Novartis;
- contained numerous specific references to a set of clinical guidelines that recommend Gleevec exclusively for first-line treatment of the two cancers discussed in the websites, chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST);
- discussed the use of a certain class of anti-cancer drugs for first-line treatment of CML and GIST, often in conjunction with the Novartis name -- yet Gleevec is the only product in this drug class indicated for these uses and the only one made by Novartis for these uses, details that are “well known in the oncology community”; and
- presented data and corresponding literature references with titles that included the established name of the drug (imatinib), and at least one of these literature references described the pivotal clinical study submitted to FDA in support of the Gleevec approval.
These and other factors made FDA consider the websites “Gleevec-specific promotions” and thus subject to FDA regulation. FDA identified in these promotional sites a number of alleged violations, including promotion of an unapproved use for Gleevec and omission or minimization of risks associated with the drug.
FDA did further detective work in tracing back to Novartis a third website, www.bloodleveltesting.com, which was prominently displayed on the two main “Gleevec-branded” websites above and which included allegedly unsubstantiated dosing claims for Gleevec. A pop-up disclaimer for this third website -- you are “moving to an external website independently operated and not managed by the Novartis Pharmaceuticals Corporation” -- did nothing to dispel FDA’s belief that Novartis was responsible for its content. Among other links to Novartis, FDA found that the website was registered to Novartis, included repeated references to Novartis and hyperlinks to the two “Gleevec-branded” websites above, and identified no other pharmaceutical manufacturers or drugs in Gleevec’s drug class except Novartis and imatinib (Gleevec’s established drug name), respectively. That Novartis offered a Blood Level Testing Program at no cost to healthcare providers further suggested a link between the company and the site www.bloodleveltesting.com. Finding Novartis “at least partly responsible for the content of this website,” FDA faulted Novartis for the website’s unsubstantiated dosing claims, which FDA found “deeply troubl[ing]” from a public health perspective.
This Warning Letter confirms what the November 2009 public hearing, and an earlier batch of Untitled Letters concerning “sponsored-links” (issued on March 26, 2009 and posted in April 2009 here), already indicated: websites, even apparently “unbranded” websites, are under increasing FDA scrutiny. Companies should be careful about how connected they are to disease awareness and other informational sites. Too many connections -- even despite pop-up disclaimers and the like -- may cause FDA to consider the websites promotional materials and fault the company for any information therein that may be misleading or otherwise in violation of the Federal Food, Drug, and Cosmetic Act.
- Margaret Renner and Daniel Kracov
