A recent ruling on the First Amendment rights of drug companies may be a stimulus for future mass tort claims. On August 7, 2015, the U.S. District Court for the Southern District of New York granted Amarin an injunction against the FDA from criminally prosecuting the drug manufacturer for communicating truthful, non-misleading information about off-label use of drugs, holding that the First Amendment rights of the company protected it from such prosecution. Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015). This ruling may be a first step toward a new, more relaxed regime in regulation of drug marketing that ultimately spurs more mass tort litigation.
For those unfamiliar with the suit, Amarin sought the injunction in connection with its marketing of off-label uses for the drug Vascepa, a drug that lowers triglyceride levels. The indication in the drug’s original drug application was to lower triglyceride levels. Amarin sought to promote the drug for other indications that had not been reviewed for efficacy in the original application process, such as to lower triglyceride levels in patients with persistently high triglycerides (i.e., patients that haven’t had success with statin therapies) and to decrease the risk of adverse cardiovascular events. It was, by and large, undisputed that there was truth and scientific backing to these allegations though not proven to the degree required by the FDA drug approval process.
FDA regulations, in an effort of striking a balance between drug companies’ First Amendment rights and throttling the flow of information about off-label use, restricted drug companies from disseminating information about off-label use on an unsolicited basis, requiring doctors to first request such information from the drug company. The FDA’s main concern is that allowing drug companies to make truthful, non-misleading statements about off-label uses undermines the safety and efficacy objectives of the drug approval process by removing the incentive for companies to spend the time and money testing its drugs for new uses after initial approval.
The lawsuit challenged the Food, Drug and Cosmetic Act’s ability to criminalize truthful, non-misleading statements about off-label uses to physicians as “misbranding,” averring that such regulations are an unconstitutional prior restraint on commercial speech that is protected by the First Amendment.
Ultimately, the Court held that Amarin was likely to succeed on the merits and granted the preliminary injunction against the FDA because, among other things, communication of truthful, non-misleading information about off-label uses is protected commercial speech under the First Amendment, the FDCA and FDA regulations fail to demonstrate that they further their public purpose, and they were not narrowly tailored to be a minimally burdensome means of achieving the purpose.
With respect to the regulations serving a public purpose, the Court found that, despite the attendant safety risks of drugs being used for indications without a pre-approval process, off-label use is widely practiced and “penalizing truthful statements promoting off-label use paternalistically interferes with the ability of physicians and patients to receive potentially relevant treatment information.” Id. at 28 [citations and internal quotations omitted].
In addition, the court ruled that the unconstitutionality of the FDA’s categorical ban on communication of truthful, non-misleading information about off-label uses “applies no matter how obvious it was that the speaker’s motivation was to promote such off-label use.” Id. at 51. Indeed, the Court’s reasoning appears to provide a robust shield protecting the right of drug companies to promote off-label uses under the First Amendment.
Importantly, the Court—presumptively aware of (and concerned about) the potential for drug marketing efforts to run rampant absent the chilling effect of criminal liability—pointed out a number of caveats:
“First, the First Amendment does not protect false or misleading commercial speech. . . . Second, the First Amendment protects expression, not conduct. A manufacturer that engages in non-communicative activities to promote off-label use cannot use the First Amendment as a shield. . .
A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading . . . representations result. . .
[T]he dynamic nature of science and medicine is that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired. . . Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.”
Practically, the real battle in this case isn’t over the right to promote truthful content about off-label uses, but the more general goal of securing a baseline of access to physicians to engage in whatever dialogue drug companies see fit about off-label use under the guise of “truthful, non-misleading” information. The FDA has been defanged by this decision in a major way, losing one of its most powerful weapons in discouraging off-label promotion. Without question, this ruling will result in an uptick in the volume of information communicated by drug companies to doctors about off-label use, much of which will not have the backing of a clinical trial process meeting the standards of the FDA’s new drug application process. It will also lead to more prescriptions being written.
In all likelihood, there will be missteps in drug companies’ monitoring of the communications and conduct of their sales forces about off-label use, as well as episodes of tenuously justified information about off-label use being proven false after widespread distribution to physicians. Additionally, what is false or misleading is, by its very nature, a fact-specific inquiry, as is the question of whether certain methods of promotion constitute permissible expression or prohibited conduct. Consequently, this case very well may create a rising tide of future civil claims against drug companies that engage in such off-label promotion.
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