High Court Decision Affects Off-label Promotion: Attorneys
A U.S. Supreme Court decision last June involving First Amendment arguments in a case about township sign codes has certain implications for how FDA regulates off-label promotion, according to Reed and Smith attorneys. Writing in a recent Washington Legal Foundation Legal Backgrounder, they say the decision “significantly affects the regulation of truthful and non-misleading speech generally, in both commercial and non-commercial contexts.”
The backgrounder discusses how previous content-based restrictions on commercial speech have traditionally undergone an intermediate level of scrutiny per the four-prong test of Central Hudson. “Courts, however, are beginning to apply heightened scrutiny to some commercial-speech restrictions,” the attorneys write. “Heightened scrutiny ‘is something short of a least-restrictive-means standard that the government must meet under strict judicial scrutiny’ and requires ‘a fit that is not necessarily perfect, but reasonable; that represents not necessarily the single best disposition but one whose scope is in proportion to the interest served; that employs not necessarily the least restrictive means but ... a means narrowly tailored to achieve the desired objective.’”
The case at hand, Reed v. Town of Gilbert, AZ, concerned a township sign code that prohibited display of certain outdoor signs without a permit. “Prior to Reed, such an ordinance would have been subject to strict scrutiny only if designed to suppress speech with which the government did not agree,” the backgrounder notes. “Therefore, the Ninth Circuit applied a lower level of scrutiny, concluding that the sign code did not violate the First Amendment, because it was ‘content-neutral.’” The Supreme Court overturned that ruling and concluded that strict scrutiny should apply more broadly. “The majority held that any law that discriminates based on a topic must overcome strict scrutiny, irrespective of the legislative motive behind the law,” the attorneys say.
Reed was not a commercial-speech case, the backgrounder notes, and it demonstrates that the high court is eroding the distinction between the levels of scrutiny that previously applied to commercial and non-commercial speech. FDA’s regulation of off-label speech is topic based — “meaning speech is prohibited if on one topic (off-label uses) but permitted if on another (on-label uses),” the backgrounder says. “It is also speaker based, in that anyone other than a regulated manufacturer is free to make the same statements about a product’s off-label uses that would subject the manufacturer to an FDA enforcement action. As a result, Reed’s holding has the potential to impact FDA regulation of off-label promotion. Consistent with Reed, FDA’s regulation of truthful, non-misleading speech about the off-label use of pharmaceutical products or medical devices would not be subject to the usual intermediate scrutiny via the commercial-speech doctrine of Central Hudson, but rather at least to the ‘heightened’ scrutiny of Sorrell.”
In conclusion, the attorneys say Reed suggests that FDA’s current off-label promotion regime cannot satisfy strict scrutiny. “The direct impact of Reed, however, is not entirely clear,” they say. “Lower courts are only beginning to consider its holding in commercial-speech cases. However, by citing to Sorrell (commercial speech) to support its position that a church sign ordinance (non-commercial speech) is unconstitutional, the majority opinion suggests that the court is no longer concerned with maintaining a strict division between commercial and non-commercial speech, at least in the context of content- or speaker-based discrimination. Should Reed ultimately be applied to off-label promotion, one potential positive result in the pharmaceutical context will likely be more truthful, non-misleading information flowing from manufacturers to physicians, who can then make informed decisions about proper treatment for patients, using their training and expertise.”