Prescription Drug Advertising Under Scrutiny: New FDA and HHS Enforcement Actions

Last month, President Trump signed a presidential memorandum, “Addressing Misleading Direct-To-Consumer Prescription Drug Advertisements.” The memorandum invokes the U.S. Food and Drug Administration’s (FDA) authority to regulate prescription drug advertising, noting that the agency has historically required manufacturers, packers, or distributors to provide consumers with materially complete information regarding the benefits and risks of the advertised drug.

In the memorandum, Trump directs Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. to take “appropriate action” to ensure transparency and accuracy in direct-to-consumer drug advertising, including increasing the amount of information that must be disclosed regarding the risks associated with the drug. The Commissioner of Food and Drugs is also directed to take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions.

New Federal Oversight of Direct-to-Consumer Drug Advertising

On the same day, the FDA issued a news release announcing that it is sending thousands of letters warning pharmaceutical companies to remove what the FDA characterizes as misleading advertisements and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.

The letter lists the following concerns the FDA states that it intends to take “aggressive action” on:

• Patients are not seeing a fair balance of information regarding drug products, such as when serious risks are not clearly presented or are too difficult for seniors to read or hear
• Reliance on digital and social media channels, including undisclosed influencer promotions, blurring the lines among editorial content, user-generated media, and pharmaceutical advertising
• Citing a journal review article that purportedly found that while “100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms” and that 88% of advertisements for top-selling drugs failed to adhere to the FDA’s “fair balance” guidelines

What Comes Next for Pharmaceutical Advertising Regulation

These actions were taken in conjunction with HHS’s Strategy Report, “Make Our Children Healthy Again,” which contains an array of initiatives. Relevant here, the report calls out direct-to-consumer drug advertising, highlighting social media influencers and DTC telehealth companies. The report states that the FDA, HHS, Federal Trade Commission, and Department of Justice will increase oversight and enforcement. Further actions that could be taken by federal regulators remain to be seen.

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