Cross-posted at on WLF contributor site.

Through a 2007 amendment of the Federal Food, Drug and Cosmetic Act , Congress empowered FDA to “require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement.” The agency has issued a proposed guidance document to implement the amendment, Guidance for Industry: Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program.

A May 25 Washington Legal Foundation Legal Opinion Letter, Ready For Primetime?: FDA’s Proposed Guidance On Pre-Screening Of DTC TV Drug Ads, provides an overview of the proposed guidance. Authored pro bono for WLF by three McDermott Will & Emery attorneys led by former AstraZeneca general counsel Glenn Engelmann, the paper notes that even though the guidance is “non-binding,” companies should be prepared to share their TV ads with FDA before they hit the air.

If this sounds like a prior restraint on speech, that’s because, in WLF’s opinion, it is. Advertising is commercial speech, which happens to be FDA’s least favorite type of speech. The agency has long encouraged companies to submit their drug ads for FDA review, and a drug industry trade association code of conduct also encourages its members to do so. But the 2007 congressional amendment, and FDA’s implementing guidelines, are an entirely different thing.

The Supreme Court has routinely held that government demands to review speech before it is uttered publicly are highly suspect under the First Amendment. This is particularly the case when government provides little or no standards to limit its discretion. The FDA’s DTC guidance offers no such standards. The document sweeps in just about every imaginable drug ad and just in case one doesn’t fit neatly into one of its five prescribed categories, FDA offers a sixth category: “Any TV advertisement that is otherwise identified by FDA as subject to the pre-dissemination review provision” (emphasis added). This means, in other words, “any ad that we (FDA) think requires review, because we’re FDA, and we know.”

FDA’s guidelines are neither narrowly tailored to meet the government’s health objective, nor can they be justified with actual evidence, as Supreme Court commercial speech jurisprudence requires. Comments by the Pharmaceutical Research and Manufacturers of America (PhRMA) effectively question the need for such extreme measures, which goes to the “narrow tailoring” point, by noting that there is an intermediary between the consumer and the advertised drug – a physician:

Indeed, it is the physician, not the patient, who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient. Consequently, the need for a pre-dissemination review to protect the public health is suspect in this context because any potential misperceptions communicated by a DTC television advertisement, of necessity, will be quickly corrected prior to use through an intervening consultation with the patient’s treating physician.”

FDA adds insult to First Amendment injury by issuing these requirements through a guidance document rather than formal rulemaking. Does FDA seriously believe that regulated entities will embrace the guidance’s statement that it “does not operate to bind FDA or the public”? Once finalized, the guidance will be treated as binding and as such, companies deserve the protections that the Administrative Procedures Act provides.

FDA should withdraw its guidance and proceed through formal notice-and-comment rulemaking. Whether FDA can craft a rule that will withstand constitutional scrutiny is open to serious doubt. WLF believes that the 2007 amendment empowering FDA to pre-screen ads is unconstitutional, as would be any FDA effort to implement the law. PhRMA’s comments should send a message to FDA that it or its members might be willing to sue FDA over the new rules. Given its record in court lately, that is an outcome FDA should not encourage.