By Kate Greenwood
Cross-Posted at Health Reform Watch
At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements. The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information.
Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]” Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach. In a Tweet commenting on Gaffney’s article, Patricia Zettler–a Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges.
Commercial speech is only protected under the First Amendment if it is not false or–perhaps more relevant in the context of direct-to-consumer advertising–misleading. In Christopher Robertson’s recent essay in the Boston University Law Review, he argues that when the truth about a claim is known, as it likely the case with an on-label direct-to-consumer advertisement, it is sensible to put the burden on the government to “prov[e] that the true speech is misleading…given the epistemic value of truth and our aversion to paternalism, especially as a motivation for speech regulation.”
As I discussed previously here, courts called upon to decide whether an advertisement or form of advertising is true, false, or misleading are permitted “to look to the facts to determine ‘the actual effect speech will have.'” In Florida Bar v. Went for It, for example, the Supreme Court relied on the government’s “106-page summary of its 2-year study of lawyer advertising and solicitation to the District Court,” as well as an “anecdotal record . . . noteworthy for its breadth and detail” in upholding a thirty-day moratorium on direct-mail solicitation of accident victims and their families by personal injury lawyers. In Bronco Wine Company v. Jolly, a California appeals court held that a legislative finding that the descriptor “Napa” was inherently misleading was adequately supported by “the regulatory history of brand names of geographic significance,” hearing testimony, and a survey. By contrast, in Edenfield v. Fane, the Supreme Court invalidated a ban on in-person solicitation by accountants on the grounds that the Board of Accountancy failed to “validate [its] suppositions[.]”
Commercial speech doctrine does not precisely specify the level of deception, or the form or degree of proof, necessary to justify speech-restrictive regulations like those that limit direct-to-consumer prescription drug advertising. The government might have to show that such advertising is more often deceptive than not. Or, as in Lanham Act false advertising cases, it might have to show that a substantial percentage (typically fifteen to twenty percent) of a company’s customers is misled by it. Or, a significant risk of deception might be sufficient. Notwithstanding this uncertainty, FDA is wise to prepare to defend (and even fend off) future First Amendment challenges to the laws and regulations governing direct-to consumer prescription drug advertising by building up the evidence base underlying them.
Thanks for flagging this important and interesting issue, Kate. And for picking up my BULR article. I’m afraid that my writing in the segment you quoted may have been unclear. So I’d like to clarify. Here’s the full paragraph from p25 of the current version of the paper on SSRN, with clarifying inserts:
“It is important to distinguish these cases [where truth is unknown] from ones where the claim is concededly truthful but arguably misleading. In the domain of commercial speech, for such cases [of alleged misleading true speech], the Supreme Court has held that the Government bears the burden of proving that the true speech is misleading. That approach is sensible, given the epistemic value of truth and our aversion to paternalism, especially as a motivation for speech regulation. Here, however, the present question is distinct ‐‐ who should have the burden when the truthfulness is unknown? That question is unsettled.”
I then go on to argue that the Government should have the burden of proving truth.
Thanks to you, Chris, for commenting. I really enjoyed your article.
As to your point about the shifting burdens, clearly (ha!) it was my summary not your writing that was unclear. I was assuming that a defendant manufacturer would be able to prove that the–presumably on-label–claims in an advertisement targeting consumers were true. That was probably too broad an assumption, see, e.g., the study by Faerber and Kreling that was published in the Journal of General Internal Medicine earlier this year that found that 10% of the most-emphasized claims in the television advertisements they reviewed were false or unsubstantiated.
Thanks to you, Chris, for commenting. I really enjoyed your article.
As to your point about the shifting burdens, clearly (ha!) it was my summary not your writing that was unclear. I was assuming that a defendant manufacturer would be able to prove that the–presumably on-label–claims in an advertisement targeting consumers were true. That was probably too broad an assumption, see, e.g., the study by Faerber and Kreling that was published in the Journal of General Internal Medicine earlier this year that found that 10% of the most-emphasized claims in the television advertisements they reviewed were false or unsubstantiated.