President Trump signed a memorandum directing increased enforcement of prescription drug advertising regulations, prompting the FDA to issue thousands of warning letters and cease-and-desist orders to pharmaceutical companies.
President Trump signed a presidential memorandum titled "Addressing Misleading Direct-To-Consumer Prescription Drug Advertisements." The memorandum directs Secretary of Health and Human Services Robert F. Kennedy Jr. to take appropriate action to ensure transparency and accuracy in direct-to-consumer drug advertising, including increasing required risk disclosure information. The Commissioner of Food and Drugs received direction to enforce the Federal Food, Drug, and Cosmetic Act's prescription drug advertising provisions.
On the same day, the FDA issued a news release announcing it is sending thousands of warning letters to pharmaceutical companies to remove misleading advertisements and issuing approximately 100 cease-and-desist letters to companies with deceptive ads. The agency stated it intends to take "aggressive action" on advertising violations.
The FDA identified specific concerns it plans to address through aggressive enforcement:
The presidential memorandum notes that the FDA "has historically required manufacturers, packers, or distributors to provide consumers with materially complete information regarding the benefits and risks of the advertised drug."
The FDA stated it intends to take "aggressive action" on advertising violations and characterizes the targeted advertisements as "misleading" and "deceptive."
The focus on social media and influencer marketing addresses a regulatory gap that has allowed pharmaceutical companies to promote products through channels with less stringent disclosure requirements than traditional advertising. For healthcare organizations and patients, this could mean more transparent drug advertising with clearer risk information, potentially improving informed consent processes. The coordination between multiple federal agencies signals this will be a sustained enforcement priority rather than a one-time action.
These enforcement actions were taken alongside HHS's "Make Our Children Healthy Again" strategy report, which calls for increased oversight of direct-to-consumer drug advertising. The FDA, HHS, Federal Trade Commission, and Department of Justice will increase oversight and enforcement. Healthcare organizations should expect continued scrutiny of pharmaceutical advertising practices and more transparent drug risk communication.
The FDA enforces the Federal Food, Drug, and Cosmetic Act, which requires drug ads to present benefits and risks fairly.
Warning letters request voluntary compliance, while cease-and-desist letters demand immediate removal of violations.
Seniors may struggle with small print, fast audio disclosures, or complex medical terminology in ads.
Influencer promotions and user-generated content often blur the line between opinion and regulated advertising.
The FTC collaborates with the FDA to address deceptive marketing practices, especially on digital platforms.