A federal judge barred the Food and Drug Administration from blocking a drug company’s efforts to promote an unapproved use for pills derived from fish oil, saying the firm’s claims are protected by the First Amendment.
U.S. District Judge Paul Engelmayer granted Amarin Corp. preliminary relief, allowing the company to “engage in truthful and non-misleading speech promoting the off-label use” of the drug, called Vascepa.
Amarin’s suit against the FDA will continue, but the company will be allowed to begin marketing the off-label use immediately, under the judge’s decision.
“This is huge,” said Jacob Sherkow, an associate professor at New York Law School. “There have been other instances a court has held that off-label marketing is protected by the First Amendment, but . . . this is the first time, I think, that any federal court — that any court — has held in such a clear, full-throated way that off-label marketing is protected by the First Amendment, period, full stop.”
The suit is narrow in many ways; it involves the company’s right to promote one drug as a treatment for people with high triglycerides, which can be a factor in heart disease. But the case has been closely watched because it could affect the FDA’s ability to restrict the off-label promotion of all drugs.
Although doctors can prescribe approved drugs for uses that are not included in their labels, companies are restricted from marketing the drugs for other conditions if they have not received FDA approval for them.
“This lawsuit is based on the principle that better-informed physicians will make better treatment decisions for their patients,” John F. Thero, Amarin's chief executive officer, said in a statement. “Amarin will now be able to communicate efficacy data... and other relevant study results to these physicians and to others in the medical community in the context of appropriate disclaimers.”
Jeff Ventura, a spokesman for the FDA said that the agency would not comment on ongoing litigation. The FDA has said it plans to hold a meeting this summer on whether restrictions on the promotion of off-label uses violates free-speech protections.
The judge's decision does require that the off-label promotion of a drug not be misleading. For example, when promoting the drug, Amarin will also have to disclose to doctors that the drug has not been approved to treat coronary heart disease and its effect on the risk of death hasn't been determined.
Floyd Abrams, a leading First Amendment attorney from the firm of Cahill Gordon & Reindel represents Amarin in the case.
“It is . . . a very important opinion in the area of the promotion of off-label uses of pharmaceutical products, and also a very important First Amendment opinion in terms of the impact of the First Amendment in this area,” Abrams said.
Patricia Zettler, an associate professor at Georgia State University College of Law, said that there are qualifiers on the decision that make it more limited in scope: This is one district court judge’s decision; it is preliminary relief, which means the litigation is not over, and it is an unusual case in which the company had evidence supporting the use it wants to promote. That said, it “could be a really big deal,” she said.
“If other federal judges are persuaded by these kinds of arguments, it could really have wide-reaching impacts on how FDA regulates drugs,” Zettler said. “FDA would have less authority, and I think FDA’s ability to regulate approved drugs, regulate how approved drugs are used, would be more limited than it would be now.”
It also opens up the question of who adjudicates whether unapproved uses of a drug are truthful.
“That is a huge concern, with this opinion and with the marketing of an off-label use generally,” Sherkow said. “Who gets to decide whether a statement is truthful and not misleading? It’s absolutely unclear. It seems, from this opinion, it is federal courts.”
Harvard Medical School professor Jerry Avorn said it was a sad irony that the decision came on the day FDA scientist Frances Oldham Kelsey died, at age 101. Kelsey helped keep thalidomide off the U.S. market in the early 1960s and helped give the agency greater regulatory authority over drugs.
“I find the decision very troubling. It’s a big push off on to a very slippery slope, a very steep slippery slope toward removing the government’s authority to limit the claims that drug companies can make about the effectiveness of their products,” Avorn said. “There’s an enormous amount, enormous numbers of statements that drug companies could make about their products that are not overtly fraudulent, but are not the same as a comprehensive review of all the good and bad evidence, that the FDA undertakes when it reviews a drug.”
In a letter sent to Amarin in June, Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, appeared to give the company an out, saying that "you could make such a claim in connection with the distribution of your product if you were to repackage and relabel it as a dietary supplement."