WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation (WLF) says FDA’s recent “crackdown” on direct-to-consumer television advertising runs counter to First Amendment protections for commercial speech that is truthful and non-misleading. A 9/29 letter to the agency cautions that challenges to the agency’s “thousands” of Warning Letters and about 100 cease and desist letters, many addressing DTC promotions, would likely succeed because the enforcement actions “fail constitutional scrutiny.”

WLF says the agency’s enforcement letters criticize elements in TV ads like lifestyle montages, use of subscales from validated scales, and visual or audio elements that, in the agency’s view, distract from risk information, “in many cases without showing that the ads are misleading, much less deceptive.”

The letter also argues that FDA’s reliance on outdated data from 2012 to 2015 to justify its crackdown undermines the agency’s claims.

While preventing deceptive or misleading ads is a substantial interest of the government, WLF says, FDA’s actions do not advance it effectively. “Scattershot letters to all NDA and ANDA holders without specifying responsibility for violations, sweep too broadly,” the advocacy group says. “This approach can impose burdens on companies that had no role in the advertising…. FDA’s approach, amid recent staff reductions in the Office of Prescription Drug Promotion, risks arbitrary enforcement that chills protected commercial speech.”

WLF asks the agency to “reaffirm drug manufacturers’ First Amendment right to speak truthfully about their products in appropriate settings, including DTC ads, without fear that these statements will expose them to regulatory harassment or civil and criminal liability.” It suggests that the agency focus on manufacturer statements either on the drug label itself or on immediately accompanying material, and less on statements in widely circulated marketing materials. “In all events,” it concludes, “FDA must abide by First Amendment restrictions on FDA authority recognized in binding First Amendment case law. In fact, FDA should undertake a systematic review of its rules, policies, and procedures to ensure that they do not exceed the agency’s constitutional and statutory reach.”