FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising.  This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”

The HHS news release outlines the FDA’s intention to double down on its enforcement against misleading drug advertising, asserting that the FDA will “no longer tolerate” misleading pharmaceutical ads, and will instead “aggressively deploy its available enforcement tools.” Per the release, this aggressive deployment includes the following:

Issuance of Warning Letters: In tandem with the news release, the FDA sent thousands of warning letters to pharmaceutical companies. The news release links to a generic warning letter outlining the Agency’s concerns about deceptive pharmaceutical advertising, and directing the recipient to “remove any noncompliant advertising and bring all promotional communications into compliance.” The letter does not specify a time frame for compliance.

Issuance of Cease-and-Desist Letters: The release further states that the FDA has issued approximately 100 cease-and-desist letters to companies with advertising it considers deceptive.

Closing the “Adequate Provision” Loophole: The FDA states that it has initiated rulemaking to close the 1997 “adequate provision” loophole. This regulatory framework permitted pharmaceutical companies to provide only a major risk statement for drug products in advertising, while omitting more comprehensive safety information by instead directing viewers to a separate source, such as a website or phone number, for full prescribing information.

HHS released a fact sheet with further information about how it intends to close the loophole, which it says would include “return[ing] to the status quo policy pre-1997.” That policy, according to HHS, required pharmaceutical ads “to report full contraindications, boxed warnings, and common precautions in advertisement,” which made pharmaceutical broadcast ads “rare” due to “the time it would take to read safety information.”

Implementation of Technological Monitoring Tools: The Agency states that it has implemented AI and other tech-enabled tools to surveil and review drug advertisements.

This enforcement activity is part of a wave of mounting scrutiny on pharmaceutical advertising, including the FDA’s 2024 enactment of stringent rules amending advertising regulations for prescription drugs. While the long-term impact of this new era of enforcement is uncertain, pharmaceutical companies should act now to avoid being caught in the enforcement upsurge. Important steps include proactively reassessing direct-to-consumer advertising materials, with an emphasis on the adequacy of their existing major risk statements, reviewing internal processes to ensure uniform compliance across all platforms, and analyzing any agreements that could impact advertising promotions. For more information, please reach out to our Crowell & Moring team.