In a warning letter dated April 21, 2010, the Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising and Communications (DDMAC) cited a pharmaceutical company for improperly promoting its cancer drug in violation of the Federal Food, Drug, and Cosmetic Act (FDC Act).1 The agency concluded that the company’s sponsorship of two informational websites on gastrointestinal stromal tumors (GIST) and chronic myeloid leukemia (CML) was a veiled attempt to promote the use of its drug product for the treatment of these diseases. After deciding that the websites were product- specific promotional materials, the agency found that the websites were also false and misleading because they promoted an unapproved use for the drug, failed to disclose the associated risks and made unsubstantiated dosing claims that placed patients at increased risk for serious adverse events.
Although the websites were supposedly designed to provide disease-state information on GIST and CML and neither website specifically referred to a particular drug product, the agency considered a combination of factors to conclude that the websites were violative promotional materials for the drug. The DDMAC focused on the websites’ content, which discussed the use of tyrosine kinase inhibitors (TKIs) for the treatment of GIST and CML, “often in conjunction with the [company] name.” Specifically, the agency observed that the drug product is the only TKI indicated for first-line treatment of both diseases, as well as the only TKI made by the pharmaceutical company indicated for the treatment of both diseases. The DDMAC noted that such product details would be well-known in the oncology community.
The DDMAC also linked the websites to the particular product because they contained the company logos, direct links to the specific’s product website, and “perceptual” similarities in design in comparison to the product website (i.e., similar color scheme using of a distinct shade of orange, design layouts and other presentation elements). In addition, both websites expressly discussed sponsorship by the drug company, were registered to the company and presented clinical study data and literature references that provided the drug’s established name.
Citing concerns about the websites’ content from a “public health perspective,” the DDMAC also found that the websites misleadingly promoted an unintended use of the drug. Several claims in the sections directed at healthcare professionals stated the product could be effective when used “before surgical resection of GIST tumors, a use for which [DDMAC noted] the drug is not indicated” (emphasis in original). Similarly, portions of the websites directed at consumers contained statements suggesting that the drug could potentially reduce the size of GIST tumors prior to surgical removal. Despite making such prominent claims regarding the product’s effectiveness, the DDMAC noted that the websites also “failed to adequately described the risks associated with” the product, i.e., lack of fair balance, and completely omitted material information about serious risks of the drug.
The DDMAC highlighted that the websites included several unsubstantiated dosing-related claims that could increase the risk for serious adverse events and presented these misleading claims without any discussion of potential dose-related side effects. For example, the websites encouraged physicians to provide plasma level monitoring to facilitate increasing the dosage because “suboptimal” levels of the drug could limit the drug’s efficacy. The agency then noted that the drug’s prescribing information contained no provision related to plasma monitoring and, in fact, included for “very specific dosing guidelines […] with guidelines for monitoring adverse events and specific instructions for dose reduction or discontinuation,” as opposed to dose increases (emphasis in original). Both websites also heavily promoted a “CML & GIST Alliance™ Blood Level Testing Program” and recommended the services of Avantix Laboratories, another website registered to the drug company, which also contained similar unsubstantiated claims about the product, logos and links to the CML and GIST Alliances, and repeated references to the pharmaceutical company.
By issuing the warning letter, the DDMAC has demonstrated its willingness to investigate “unbranded” websites more thoroughly to determine whether they are veiled attempts intended to promote the use of a particular drug and avoid the FDA’s promotional requirements, including the provision of fair balance information about the product’s risks and limitations. The agency’s action in citing the drug company for these purported disease-state websites suggests the pharmaceutical industry cannot hide behind claims that a specific drug product is not expressly mentioned or discussed on a company-sponsored website, as an excuse from taking responsibility for compliance with the FDA’s rules.