Peruse the web site of any branded pharmaceutical or biotech company and you will likely find a section describing its pipeline. That section often summarizes investigational products, where they are in the developmental process, and provides summary results of the latest clinical trials. Communicating such information has value to both the scientific community as well as potential investors attempting to divine the company’s financial direction.
The federal regulations permit a company to engage in a full exchange of scientific information “including dissemination of scientific findings in scientific or lay media.” 21 CFR §312.7(a). A company is not, however, permitted to represent “in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation.” But when does a company cross the razor’s edge from factual communication to illegal promotion?
On June 30, 2011, the Division of Drug Marketing, Advertising, and Communications (DDMAC) issued an untitled letter to AOI Pharmaceuticals, Inc./Keryx Biopharmaceuticals, Inc. (“Keryx”) for crossing that line on its web site. DDMAC found that several of the comments in the “About Us” and “Product Pipeline” sections of the Keryx web site were “promotional,” contravening the federal regulation.
The offending claims identified by DDMAC could likely be found on dozens of other web sites. They included a representation that the compound “has demonstrated both safety and clinical efficacy.” They also reported that the “safety profile is distinctly different from that of most cytotoxic agents” and it “does not appear to cause” certain side effects common among the class. The web site summary further claimed that the trials “demonstrated that [the product] can be safely given to humans with a manageable toxicity profile” and “has been well tolerated …” A casual review of the offending website would lead one to believe that Keryx was attempting to couch these claims as clinical findings. They used words and phrases such as “demonstrated” and “does not appear” in an attempt to walk the line between communication and promotion.
Keryx also included standard disclaimer language stating that “This investigational drug product has not been approved by the US Food and Drug Administration for safety and effectiveness. This investigational drug product is still undergoing clinical study to verify its safety and effectiveness.” DDMAC determined that this disclaimer was insufficient “to mitigate the overwhelming misleading impression conveyed by claims on Keryx’s website.”
So how do you report on pipeline status and positive clinical trial results without crossing the line into illegal promotion? Keryx may have been able to avoid this untitled letter by more clearly noting that clinical trials to date had provided encouraging data on safety and efficacy while noting that additional research is required. Will your web site pass muster? Although there is no certainty, a working knowledge of untitled and warning letters will provide valuable guidance in ensuring your company’s promotional compliance.