The FDA has recently issued an untitled letter addressing the direct-to-consumer advertising of Bristol Myers Squibb’s Cobenfy, highlighting ongoing scrutiny of pharmaceutical marketing practices. This action is part of a broader trend where the FDA has been actively monitoring and responding to promotional materials that may not comply with regulatory standards. The agency’s increasing vigilance underscores its commitment to ensuring that advertising is not misleading and provides accurate information about drug safety and efficacy.
This latest letter reflects the FDA’s intensified focus on the pharmaceutical industry’s advertising strategies, particularly in the context of direct consumer engagement. For B2B professionals in regulatory, QA/QC, and marketing roles, this serves as a critical reminder of the importance of adhering to compliance guidelines in promotional efforts. Failure to do so could result in significant repercussions, including reputational damage and potential financial penalties.
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