March 5, 2012 – In a case that highlights First Amendment limits to FDA regulation of marketing, the U.S. District Court for the District of Columbia granted a motion for summary judgment Feb. 29 in favor of five tobacco companies who called unconstitutional an FDA rule requiring that new, mandatory graphic images be added to specific textual warnings included on cigarette packaging.

“The Court concludes that these mandatory graphic images violate the First Amendment by unconstitutionally compelling speech,” U.S. District Judge Richard J. Leon wrote in the court’s opinion (Civil Case No. 11-1482 (RJL)).

“If courts refuse to allow this sort of regulation of tobacco products, which cannot be used safely, it’s fair to assume that many other FDA regulations governing speech are at risk. The court’s decision reminds us that the bar for restricting speech is high,” said John Kamp, Executive Director, Coalition for Healthcare Communication.

“While the tobacco regulations were unprecedented, if the FDA can’t get tobacco restrictions past the courts, how can it possibly continue to restrict medicine companies from telling the truth about the off-label uses of their products?” Kamp continued.

The tobacco companies successfully argued that the congressionally mandated graphic warnings unconstitutionally compel speech, “and that such speech does not fit within the ‘commercial speech’ exception” allowing certain types of government-mandated, informational disclosures. In legal terms, the court decided that these mandated warnings had to be analyzed under the “strict scrutiny” test of First Amendment law and that the rules failed that standard.

Stating that the FDA rule’s graphic-image requirements are not the type of purely factual disclosures that are reviewable under a less-stringent standard, the court found that the FDA failed to satisfy the burden of demonstrating that its rule is narrowly tailored to achieve a compelling government interest and, thus, violated the First Amendment.

“While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for Government advocacy can be frustratingly blurry, here the line seems quite clear,” the opinion states.

In light of the court’s decision, “it’s fair to ask how the increasingly intrusive ‘fair balance’ disclosures would fare under the ‘compelled speech’ theory applied in this case,” Kamp said. “Even more importantly, it’s time for the industry to ask whether the compelled disclosures do more harm than good to the public health.”