The Food and Drug Administration’s (FDA) Division of Drug Marketing, Advertising, and Communications (DDMAC) recently issued an Untitled Letter1 to a drug company regarding statements on the company’s website about its investigational cancer therapy product. DDMAC found that the statements “suggest that the drug is safe and/or effective for the purposes for which it is being investigated,” in violation of 21 C.F.R. § 312.7(a).
FDA regulations prohibit companies from making promotional statements representing that a drug product under investigation is safe or effective prior to its approval.2 DDMAC identified statements that referred to the product’s safety and clinical efficacy and asserted that trials had shown that the drug product “can be safely given to humans with a manageable toxicity profile.” The agency took issue with statements that the drug “has generally been well tolerated when used as a low daily dose in combination with these approved agents” and that its “safety profile is distinctly different from that of most cytotoxic agents.” DDMAC said the website claims suggested the investigational drug “was safe and/or effective for the treatment of various kinds of tumors, both as a single agent and in combination with other therapies, when it has not been approved for these uses.”
Although 21 C.F.R. § 312.7(a) specifically notes that the prohibition “is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media,” DDMAC found the website’s statements to be promotional, rather than educational. The company’s website included a disclaimer that the drug was investigational and still undergoing clinical studies to evaluate safety and effectiveness, but the agency noted that this disclaimer was “not sufficient to mitigate the overwhelming misleading impression” that the product is safe and effective.
The letter serves as a reminder that companies must exercise caution when discussing investigational products prior to FDA approval. Statements discussing a drug product’s unique properties or composition may be interpreted as implying a proven clinical benefit. DDMAC continues to attend medical meetings and review company websites for unlawful promotional materials. In addition, DDMAC has strengthened its enforcement efforts through the “Bad Ad” Program, which encourages healthcare professionals to notify the agency of potential unlawful promotional conduct. Therefore, companies must remember that DDMAC is watching for statements made concerning all drug products, whether approved or in development.