President Donald J. Trump just signed a memorandum aimed at addressing misleading direct-to-consumer (DTC) prescription drug advertisements.
The action aligns with Health and Human Services Secretary Robert F. Kennedy Jr.’s long-standing criticism of DTC drug ads, which he argues contribute to overmedicalization and mislead consumers. Kennedy has stated, “Pharmaceutical ads hooked this country on prescription drugs,” emphasizing the need for transparency to break this cycle.
The U.S. and New Zealand are the only countries allowing broad DTC pharmaceutical advertising. Despite widespread violations, the FDA has been increasingly lax and reactive in its enforcement approach over the last few decades. The FDA used to send more than a hundred warning letters each year, and misleading ads were rare. But over time, enforcement waned and the number of warning letters sent to pharmaceutical companies dropped to one in 2023 and zero in 2024.
On the same day as the Presidential memorandum, the FDA announced it is sending approximately 100 cease-and-desist letters and thousands of warning letters to pharmaceutical companies and online pharmacies for deceptive ads. The FDA said that it will no longer tolerate such deceptive practices. Going forward, the agency will aggressively deploy its available enforcement tools. The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.
A 2024 review in the Journal of Pharmaceutical Health Services Research reveals that while 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms. Moreover, 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.
The Pharmaceutical Research and Manufacturers of America (PhRMA) defended DTC advertising, citing First Amendment protections and its role in patient awareness, but expressed willingness to engage with the policy changes.
DTC advertising is a multi-billion-dollar industry, with $10.8 billion spent in 2024, including $5.15 billion on TV ads. Stricter regulations could reduce ad revenue for drugmakers and media networks, particularly if longer disclosures make TV ads less feasible.
The action stops short of a full ban on DTC ads, which Kennedy had previously advocated for, likely to avoid legal challenges on First Amendment grounds, as seen in a 2019 court ruling that blocked Trump’s attempt to require price disclosures in TV ads. Past efforts to regulate DTC ads have faced court challenges, and the current action may encounter similar resistance, especially given the Supreme Court’s 2025 ruling overturning the Chevron doctrine, which limits executive regulatory authority.
The memorandum directs the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to enhance transparency and accuracy in DTC pharmaceutical advertising, particularly by increasing disclosures of drug risks and side effects. It seeks to ensure ads provide a fair balance of benefits and risks, as mandated by existing regulations under the Federal Food, Drug, and Cosmetic Act (FDCA).
The action targets both traditional media (e.g., TV) and digital platforms, including social media, where ads often lack proper disclosures. It addresses issues like undisclosed influencer promotions and online pharmacies flouting rules that larger pharmaceutical companies follow.
The administration is also closing a 1997 FDA “adequate provision” loophole, which allowed companies to provide abbreviated side effect information in ads by directing consumers to external sources (e.g., websites). This change may require longer, more detailed disclosures, potentially impacting ad formats.