WLF Warns FDA Against Overreach in “Crackdown” on Prescription Drug Advertising

“FDA’s aggressive enforcement risks chilling truthful commercial speech affecting public health, where information can save lives.”
—Cory Andrews, WLF General Counsel & Vice President of Litigation

Click here for WLF’s letter.

(Washington, DC)—Washington Legal Foundation (WLF) today sent a letter to the Food and Drug Administration (FDA) warning against overreach in the agency’s recent crackdown on direct-to-consumer (DTC) television advertising of prescription drugs. WLF contends that while FDA has authority to combat truly deceptive ads, its broad enforcement actions threaten legitimate commercial speech without clear evidence of widespread violations.

The letter responds to FDA’s September 9, 2025, announcement of approximately 100 cease-and-desist letters and thousands of warning letters to drugmakers, following President Trump’s memorandum directing stricter oversight of DTC ads that allegedly mislead viewers on drug risks and benefits. FDA also plans to revise the “adequate provision” standard, which allows manufacturer advertisements to direct consumers to websites for full risk information.

In its letter, WLF reminds FDA that its actions must respect First Amendment limits on commercial speech regulation, citing precedents like Sorrell v. IMS Health and WLF’s successful litigation enjoining FDA from restricting off-label information sharing. The Foundation urges FDA to prioritize evidence-based enforcement over vague standards that could deter informative advertising, harming patient awareness and access to treatment options. WLF also calls for balanced regulation that advances public health without suppressing protected speech.