Aug. 28, 2012 – In a ruling that could set the stage for another U.S. Supreme Court review of First Amendment restrictions on commercial speech by FDA, the U.S. Court of Appeals for the District of Columbia ruled Aug. 24 that the FDA did not adequately support its rules under the First Amendment nor bring forward “substantial evidence” required under the Administrative Procedure Act (APA) to show that mandatory graphic warning labels on cigarette packaging would reduce smoking.

The 2-1 decision upholds a Feb. 29 U.S. District Court for the District of Columbia ruling granting a motion for summary judgment in favor of five tobacco companies who called unconstitutional an FDA rule requiring that new, mandatory graphic images be added to specific textual warnings on cigarette packaging. However, the Aug. 24 ruling is not in accord with a March ruling by a federal appeals court in Cincinnati, which called the 2009 Family Smoking Prevention and Tobacco Control Act constitutional.

“Without denying the need of people to stop smoking, what is very clear from this decision is that the FDA must recognize the First Amendment and the APA when regulating speech,” said Coalition for Healthcare Communication Executive Director John Kamp. “FDA is in dangerous denial about its need to respect the First Amendment. If these tobacco rules are a violation of the First Amendment, how can the FDA possibly defend bans on drug sponsors sharing information with doctors and patients about the life-saving, off-label uses of their products?” he noted.

Specifically, the U.S. Court of Appeals for the District of Columbia weighed in on an FDA proposed rule calling for warning labels that combined graphic images with textual messages and a “1-800-QUIT-NOW” smoking cessation hotline. Citing the Supreme Court’s decision in Sorrell V. IMS Health Inc., the court asserted that even when the government finds expression “too persuasive” it does not have permission “to quiet the speech or to burden its messengers.”

Because the FDA failed to present any data to support the premise that enacting the proposed graphic warnings will accomplish the agency’s goal of reducing smoking rates, the court stated that the rule “cannot pass muster under Central Hudson.”

With this issue creating a disagreement among two appeals courts – D.C. and Cincinnati – it sets up a very likely appeal to the Supreme Court to decide the First Amendment issues raised. How that plays out will have repercussions regarding the FDA’s authority to limit commercial speech for tobacco and other products it regulates.

“Until recently, the FDA has

kept the off-label restriction cases out of the Supreme Court,” Kamp said after the Aug. 24 ruling. “If the Supreme Court rules against FDA on this one, that ‘luck’ is unlikely to last.”

The appeals court states that even if it can be assumed that the marketing efforts of the tobacco companies in this case can be “properly classified as commercial speech, and thus subject to less robust First Amendment protections, a thorny question remains: how much leeway should this Court grant the government when it seeks to compel a product’s manufacturer to convey the state’s subjective – and perhaps ideological – view that consumers should reject this otherwise legal, but disfavored product?”

The images and the hotline name proposed by the FDA “cannot rationally be viewed as pure attempts to convey information to consumers,” the ruling states. “They are unabashed attempts to evoke emotion … and browbeat consumers into quitting.”

The court also holds that the FDA “has not provided a shred of evidence – much less the ‘substantial evidence’ required by the APA – showing that the graphic warnings will ‘directly advance’ its interest in reducing the number of Americans who smoke.” Further, the court found the FDA’s reliance on data

from Canada “underwhelming.”