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. 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 that the true speech is misleading…given the epistemic value of truth and our aversion to paternalism, especially as a motivation for speech regulation.”Īs 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. 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.Ĭommercial 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. 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. 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.
#Boston legal torrent torrent
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.
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