Federal Judge’s Ruling Bars FDA From Restricting Off-Label Marketing

On Friday, a federal judge ruled that FDA cannot prevent Amarin Corporation from advertising off-label uses of its drug Vascepa, the Washington Post's "Wonkblog" reports (Johnson, "Wonkblog," Washington Post, 8/7).

Background

FDA approved Vascepa in 2012 for treating individuals with very high triglyceride levels but denied Amarin's request to approve the drug for use in individuals with "persistently" high levels. When FDA rejected the other use, it said it would consider taking legal action if Amarin promoted such use without FDA approval (Pollack, New York Times, 8/7). Amarin then sued FDA and asked the court to allow it to promote the off-label use of the drug (Wonkblog," Washington Post, 8/7).

According to the Wall Street Journal, FDA has held that drugmakers are violating the law if they try to market a drug for a use not approved by the agency. FDA in June 2014 said it would release guidance about new standards for promoting medical products, though it has yet to do so (Burton, Wall Street Journal, 8/7). According to the Times, FDA might have been waiting for the Amarin ruling before proceeding (New York Times, 8/7).

Meanwhile, physicians are allowed to prescribe drugs for uses not included on their labels ("Wonkblog," Washington Post, 8/7).

Ruling Details

U.S. District Judge Paul Engelmayer's ruling grants Amarin temporary relief and takes effect immediately. However, Amarin's suit against FDA will continue ("Wonkblog," Washington Post, 8/7).

In his ruling, Engelmayer said under the First Amendment, Amarin "may engage in truthful and non-misleading speech promoting the off-label use of Vascepa." He added that sharing such information cannot act as the basis for the government to charge the drugmaker and its salespeople (Wall Street Journal, 8/7).  

The ruling comes after a federal appeals court recently vacated a conviction of a pharmaceutical sales representative, Alfred Caronia, who had promoted off-label use of another drug. The court held that the speech was protected under the First Amendment, provided that it was truthful and not misleading.

FDA argued the Caronia case is not meant to serve as an overarching protection for off-label marketing. It called Amarin's move a "frontal assault" to the federal framework for drug regulations.

However, Engelmayer said the Caronia ruling applies generally, including to the Amarin case (New York Times, 8/7).

FDA has 60 days to appeal the ruling (Peronne, AP/Miami Herald, 8/7).

Implications

Jacob Sherkow, an associate professor at New York Law School, called the ruling "huge," adding, "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."

At the same time, Patricia Zettler, an associate professor at Georgia State University College of Law, noted that several qualifiers limit the case's scope. For example, the case is a single district court judge's decision, the underlying lawsuit is still pending and the company had evidence to support the use it hopes to promote. Nonetheless, Zettler said the case "could be a really big deal."

Harvard Medical School Professor Jerry Avorn called the decision "very troubling," adding, "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" ("Wonkblog," Washington Post, 8/7).

Alan Bennett, an attorney with the firm Ropes & Gray, said the decision "underscores the need for the FDA to rethink and make changes in how it regulates medical information. This is just the latest court decision that challenges the underlying policies of the regulatory oversight system" (Wall Street Journal, 8/7).