On September 9, 2025, the U.S. Food and Drug Administration (FDA) announced it is launching a targeted initiative to combat deceptive drug advertising. According to the announcement, the FDA sent thousands of letters warning pharmaceutical companies to remove alleged misleading ads, in addition to issuing approximately 100 cease-and-desist letters to companies with alleged deceptive ads. This initiative will also involve rulemaking to address the "adequate provision" loophole that the FDA believes has enabled some companies to exploit digital platforms without full risk disclosures. This latest effort underscores the agencies' concern that patients are not seeing a fair balance of information about drug products.
Notably, the announcement emphasizes that the agency will aggressively deploy its available enforcement tools, and is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.
Manufacturers should undertake a review of all forms of advertising strategies, advertising media, and all related materials to ensure alignment with FDA requirements, including the clear presentation of risks and benefits.
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