Health Law Advisor

On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer (DTC) advertisements in violation of the federal Food, Drug, and Cosmetic Act (FDCA). The warning letters issued largely from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The FDA also released nearly 40 untitled letters sent to specific drug manufacturers from its Office of Prescription Drug Promotion on September 9 and 23, similarly informing them that one or more direct-to-consumer TV ads misbrands a specific drug.

These actions follow the September 9th announcement that the U.S. Department of Health and Human Services (HHS) and the FDA would be targeting “misleading” DTC pharmaceutical advertisements—the same day that a presidential memorandum directed HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin A. Makary to act.

The letters also reflect a broader shift in the FDA’s oversight of pharmaceutical advertising, particularly in DTC channels. With regulators taking a more aggressive posture across both broadcast and social media platforms, companies should be prepared for shifting regulatory requirements and heightened enforcement risk.

Reports in the last week stated that the computer manufacturer Lenovo had preloaded software onto various lines of computers which critically compromised cybersecurity. The software in question is a product called Superfish Visual Discovery, a program generally designed to replace advertisements seen while browsing the Internet with ads provided by Superfish. However, the method of implementation opens up a universe of potential problems.

What Does Superfish Do?

Superfish is designed to replace Internet advertisements with advertisements provided by their sponsors. In ...

On November 13, 2014, the Food and Drug Administration ("FDA") announced a proposed study on spousal influence on consumer understanding and responses to direct-to-consumer prescription drug advertisements.  FDA notes that consumers are often thought of as individual targets for prescription drug advertisements, without considering the social contexts in which many treatment decisions are made.  For example, FDA notes that when spouses view an ad together a spouse "may influence their partner by expressing concern about risk and sides effects that might occur ...