In Op-Ed, WLF Advisory Board Member Questions FDA “Crackdown” on Pharma Ads
In a December 9, 2025 Washington Examiner op-ed, WLF Legal Policy Advisory Board member and former Food & Drug Administration (FDA) Chief Counsel, Dan Troy, criticized federal regulators’ approach to direct-to-consumer (DTC) advertising of prescription drugs.
The Department of Health and Human Services announced this self-styled crackdown on September 9, 2025, sending nearly 100 warning letters to advertisers. Many of those letters addressed DTC ads and complained about video or audio elements that purportedly distract consumers from the required risk information. WLF criticized the agency’s scattershot approach in a September 29, 2025 letter to FDA’s lead drug regulator, reminding the agency that it must obey the First Amendment.
More recently, WLF published a paper by our Senior Litigation Counsel, Zac Morgan, explaining how the First Amendment would constrain HHS efforts to expand TV-ad disclosure requirements and additional mandates.
It was the threat of First Amendment litigation, Dan’s op-ed explains, that nudged FDA toward a more realistic approach on companies’ communication of major risks in advertisements. He writes:
That compromise was successful: consumers were notified, the courts were happy, and communication took flight.
Oddly, now the FDA labels the “adequate provision” a “loophole.” It was and is no such thing. It is a necessary accommodation to allow consumers to receive truthful, non-misleading, scientifically substantiated information about medical products that could save their lives.
Extreme disclosure requirements would “render[ ] communication impossible,” Dan writes, an outcome that not only is “presumptively unconstitutional,” but also one that disserves the very consumers HHS claims to protect:
A truthful drug advertisement, which identifies benefits, states possible risks, and directs viewers where to go for more information, is not just marketing. It is part of a broad public debate about health, innovation, and people’s individual empowerment.
Dan’s colleagues at Berkeley Research Group, Ceren Canal Arouba, and Professor Putnam Keller of Dartmouth College, conveyed a similar concern in a December 4 Law360 commentary:
Today’s patient is an active participant in their health decision-making, armed with informed choices and collaborating with doctors on treatment plans. Some studies indicate DTC promotion can prompt action, particularly searches for more information and increased use of online resources among consumers.
Some point to DTC advertisements’ ability to educate consumers about diseases and treatment options they might not otherwise know about. Studies also indicate DTC advertisements can serve as reminders to take prescribed drugs.
Thus, less or no DTC prescription drug advertising could result in limiting or removing an accessible information source available to consumers, affecting their health decision-making and medication compliance.