September 3, 2015, Trial News
FDA cannot prohibit the promotion of truthful, off-label uses
Rose Catherine Hernandez
A federal district court in New York ruled that the FDA cannot stop a drugmaker from promoting its products for off-label use if those claims are truthful. Plaintiff attorneys are concerned about what this ruling means for consumer safety.
A federal district court in New York ruled that the FDA cannot stop a drugmaker from promoting its products for off-label use if those claims are truthful. (Amarin Pharma Inc. v. U.S. Food & Drug Admin., 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). Plaintiff attorneys are concerned about what this ruling means for consumer safety.
In 2012, Amarin Pharma Inc. received FDA approval to market its drug Vascepa for treating patients with very high triglyceride levels. The next year, Amarin sought approval to market Vascepa for patients with elevated, but lower levels of triglycerides. The FDA refused to approve the promotion of Vascepa for that use. Amarin appealed the decision through three successive levels of FDA review in 2014 and 2015, but the agency ultimately denied approval.
In April, the FDA warned Amarin that it could be subject to a misbranding action if it marketed Vascepa for treating patients with elevated, but lower levels of triglycerides. Amarin sued the agency, alleging that its ban on promoting an approved drug’s truthful off-label use violates the First Amendment.
Amarin sought a preliminary injunction requesting that the court quash the FDA’s prohibition of Amarin’s proposed off-label promotion—provided it was both truthful and non-misleading speech—as unconstitutional. Both parties raised questions about the scope of United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). There, the Second Circuit vacated the conviction of Alfred Caronia, a pharmaceutical company sales representative who was caught on tape promoting an off-label use of the narcolepsy drug Xyrem. The court found that as long as Caronia’s speech was truthful and not misleading, it was protected by the First Amendment.
At trial, Amarin asserted that under Caronia, it had a First Amendment right to provide doctors with accurate information about its drug, especially because the FDA already allows competitors to market similar products to the same patients. The drugmaker also argued that the FDA had less latitude after Caronia to bring misbranding actions based on truthful statements promoting the off-label use of FDA-approved drugs.
The FDA argued that efforts to expand the Second Circuit’s decision undermine the federal framework for regulating drugs. In addition, the agency asserted that Caronia relied on the very narrow facts of that case and was not meant to be a blanket protection for off-label marketing. The FDA also argued that it could still protect patients, even under Caronia, as long as it had denied a product’s approval for off-label use, because marketing statements can demonstrate a manufacturer’s intent to misbrand a drug.
The court acknowledged that the case raises an essential question: Can the FDA bring an action for misbranding based only on “truthful and non-misleading speech promoting an off-label use of an approved drug?” The court began by reviewing the elements required for granting a preliminary injunction. Closely analyzing Caronia, the court found that where protected speech is at issue, if that speech is both truthful and non-misleading in encouraging the off-label use of an already FDA-approved drug, it cannot be the issue of a misbranding action. Though the FDA argued that protecting a drug company’s truthful speech aimed at promoting off-label use had the potential to eviscerate FDA approval mechanisms, the court noted that drug-approval framework predates modern, First Amendment legal protections of commercial speech.
The FDA had urged the court to limit Caronia to protect only certain types of truthful and non-misleading statements by manufacturers regarding off-label use. The agency argued that it disfavors certain communications over others—such as those made by sales representatives directly to doctors—because those types of statements are more likely to reflect a manufacturer’s intent to promote off-label uses. The court found that the speech protected in Caronia did not hinge on the intent element of misbranding but on the criminal act requirement. Finally, the court emphasized that Caronia applied across the board to all truthful and non-misleading commercial speech.
The court noted that Caronia does not give drug companies free reign for off-label marketing because the First Amendment does not protect false or misleading speech and because it protects expressions, not conduct. Therefore, the FDA can still bring misbranding cases when marketing representatives share misleading or untruthful information or when drug companies promote off-brand uses by illegal means.
“There are lots of potential downsides for consumers of pharmaceuticals,” said Louis Bograd, chief litigation counsel for the Center for Constitutional Litigation in Washington, D.C. “Most significantly, this ruling will encourage drug companies to be far more aggressive about promoting their products for off-label uses. Because these uses have not been reviewed or approved by the FDA, they may not prove to be safe and effective treatments, which opens the door to a lot of consumer injuries,” Bograd said.
“On the other hand, if drug companies have a First Amendment right to provide truthful information about their products, they may also have an obligation to provide truthful information about the risks or side effects of those drugs,” Bograd said. “That could potentially expose them to more liability for failing to provide warning information where they might otherwise have been able to assert a preemption defense based on FDA regulatory requirements.”