Amarin Pharma Inc. has filed a lawsuit that presents a constitutional challenge to U.S. Food and Drug Administration restrictions on off-label marketing. The suit will involve important questions for other False Claims Act (FCA) litigation, as well as issues relating to the criminal punishment of drugmakers. Also included will be issues relating to free speech rights and the FDA’s duty to set clear rules before putting the hammer down on officials. Jeff Overley wrote an article, appearing in Law360, that says there are four important issues to watch:
Caronia Clarity May Emerge
Amarin’s suit was filed in a New York federal court, which falls under the jurisdiction of the Second Circuit. As a result, this could help clarify the still-murky impact of the circuit’s 2012 ruling in U.S. v. Caronia, which found that a drug salesman was wrongly prosecuted for speech about off-label uses. Amarin is seeking a like ruling, arguing that current government policy “plainly contradicts” the Caronia ruling and that a court order protecting truthful and nonmisleading off-label promotion “falls squarely within Second Circuit precedent.” The complaint also is distinct from other recent cases, such as Solis v. Millennium, that involve off-label marketing but also are more amenable to being resolved without resorting to a First Amendment analysis. Unlike FCA suits where drugmakers can cite free speech as one of many defenses, Amarin’s requested relief is focused almost exclusively on constitutional remedies.
Big Themes May Produce Narrow Ruling
Amarin’s proposed remedies touch on broad themes. The company seeks recognition of a First Amendment right to limited off-label promotion, a declaration that FDA policies are so vague that they violate Fifth Amendment due process protections, and a conclusion that its proposed off-label speech wouldn’t breach the FCA. The American suit poses a threat to the FDA’s duty to prevent the indiscriminate dissemination of drugs that have not been adequately confirmed as safe and effective.
Speaker-Based Restrictions Are Key
One of the more powerful aspects of Amarin’s complaint asserts that the FDA is singling out drugmakers for disparate treatment — the sort of speaker-based restrictions that courts tend to eye skeptically. For example, the complaint notes that many dietary supplement makers are allowed by the FDA to claim that there is “supportive but not conclusive research” about the heart benefits of omega-3 fatty acids. Amarin wants to claim pretty much the same thing about its prescription-only fish oil drug Vascepa, and unlike supplement makers, it vows only to market to physicians, not consumers. The FDA reviewed Amarin’s clinical evidence and found insufficient support for an implicit claim of cardiovascular benefit associated with Vascepa. That review, and the deference afforded to agency prerogatives on public health, could mean that Amarin faces an uphill climb.
Confusing Rules Loom Large
A constant refrain of drugmakers in recent years has been that FDA policies on off-label promotion are too vague. Amarin’s complaint claimed the ambiguity an affront to due process.
The FDA has acknowledged that it needs to clear up the existing confusion. Last year, the agency approved citizen petitions seeking clarity on several issues related to off-label promotion. The FDA recently announced plans to hold a public meeting this summer to receive input on communications involving unapproved uses. Experts were split, however, on how Amarin’s case might be affected by the fact that regulators are currently updating policies. This case is in the U.S. District Court for the Southern District of New York.
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