Key Takeaways:
- On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced an effort to crack down on deceptive advertising. An accompanying Presidential Memorandum directs the HHS Secretary and FDA Commissioner to take action on prescription drug advertising.
- The HHS and FDA press release states that FDA is closing loopholes and stepping up enforcement regarding deceptive advertising. The press release mentions that the agency proposes to change FDA’s “adequate provision” regulation.
- Neither the press release nor the related FDA letter mentions specific regulations, policies, or FDA guidance documents that will be used to assess what constitutes deceptive advertising, but the press release specifically calls out sponsored social media posts with inadequate disclaimers regarding paid promotion.
HHS Secretary Robert F. Kennedy, Jr. and FDA Commissioner Marty Makary released a joint press release on September 9, 2025 announcing “sweeping reforms” related to direct-to-consumer (DTC) pharmaceutical advertising. The press release follows a Presidential Memo (also issued September 9, 2025) that orders the HHS Secretary to “take appropriate action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising”. The Memo calls for increased risk information to be included in DTC advertising and directs the FDA Commissioner to take “appropriate action” to enforce the Federal Food, Drug, and Cosmetic Act. In response, FDA sent “thousands” of
letters to pharmaceutical companies on September 9, 2025, and intimated that it would be sending “approximately 100” cease-and-desist letters to companies with ads that the agency is characterizing as deceptive. But how and to whom these cease-and-desist letters would be sent remains questionable. Notably, Secretary Kennedy has long been critical of DTC prescription drug advertising and has proposed banning such advertising in the past despite its protection under the First Amendment.
The press release states that FDA will initiate rulemaking to “close the ‘adequate provision’ loophole” that the agency says allows drug manufacturers to conceal safety risks. The adequate provision section of 21 CFR 202.1(e) allows manufacturers to provide methods for an audience to easily obtain a product’s FDA-approved label without needing to include a “brief summary” of all risks. Amending the “brief summary” and “adequate provision” regulations could potentially require longer advertisements or other measures that could make DTC advertisements prohibitively long, expensive, or both. The “adequate provision” section of 202.1(e) does not affect the “major statement” of risk information. FDA revised the “major statement” requirement through the Clear, Conspicuous, and Neutral (CCN) Final Rule that went into effect in 2024.
The press release mentions that social media promotion, including paid influencer promotion, may contribute to patient confusion. FDA and FTC have previously sought enforcement actions against companies for inadequate disclosures related to paid promotion; FDA has issued numerous Warning and Untitled Letters related to paid influencer advertising that did not meet the agency’s “fair balance” requirements for prescription drug advertising. The press release notes that FDA warning letter issuance in the promotional space has waned in recent years, though some of that may be attributed to successful legal challenges to previous enforcement actions and proposed agency regulations and policies. The press release is not clear about whether the step up in enforcement actions will predate the proposed changes to the “adequate provision” regulation or if FDA plans to prioritize some enforcement related to social media and paid promotion in the short term and more general enforcement in the long term.
The press release goes on to state that FDA is using AI and other tech-enabled tools to surveil and review prescription drug advertising. FDA has long used different methodologies to surveil prescription drug advertising and many manufacturers prospectively submit DTC prescription drug advertisements to FDA using Form FDA-2253 as required under FDA regulations. The press release does not mention specific artificial intelligence prompts or methods, nor does it discuss how the new tools differ from existing monitoring activities.
FDA's plans to use AI to help it monitor and crackdown on deceptive and misleading ads follow other efforts where the agency has used AI to account for a decreased work force. Since many long-serving OPDP personnel are no longer with the agency, FDA may seek to employ AI in the development of policies and regulations called for in the Presidential Memo and press release. Therefore, industry will need to carefully review any proposed regulations, policies and guidance documents related to DTC prescription drug advertising for factual accuracy and to ensure that FDA’s efforts do not exceed the agency’s statutory authority in any regard, including actions that may run afoul of the First Amendment or contradict previously issued regulations.
