September 16 2015 | Contributed by Sidley Austin LLP
On August 7 2015, in a widely anticipated ruling in the ongoing Amarin litigation against the US Food and Drug Administration (FDA),(1) Judge Engelmayer granted Amarin’s general and specific requests for relief. This ruling forcefully rejected the government’s assertion that the Second Circuit’s decision in United States v Caronia(2) does not preclude a misbranding action “where the acts to promote off-label use consist solely of truthful and non-misleading speech”.
Reading the warning labels on a medicine package. Studio isolated on a white background.
“The Court’s considered and firm view,” it held, “is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.” Amarin thus rejects the limited interpretation of Caronia that the government has been advancing for nearly three years – but the decision is more than just the ‘son of Caronia‘.
Court rejects FDA’s argument
Of major significance for FDA-regulated manufacturers, to an even greater extent than the Caronia decision itself, Amarin addresses – and rejects – the FDA’s frequently articulated rationale that it must be allowed to regulate truthful, non-misleading off-label speech about drugs in order to protect the integrity of the drug approval process and thereby safeguard public health. The court acknowledged the FDA’s contention that permitting truthful off-label speech constitutes a “frontal assault… on the framework for new drug approval that Congress created in 1962”, but explained that the 1962 legislation creating the existing drug-approval scheme simply “predates modern First Amendment law respecting commercial speech”. The court emphasised that the Federal Food, Drug and Cosmetic Act’s misbranding provisions “must be considered, and to the extent ambiguous construed, in light of contemporary First Amendment law, under which truthful and non-misleading commercial speech is constitutionally protected”. Moreover, the court twice pointed to the government’s own failure to seek further review of the Caronia holding, through rehearing or certiorari, as evidence that the government’s rhetoric about the impact of that decision was overblown.
Court adopts disclaimer approach
Both thematically and in effect, the court’s decision makes clear that the Federal Food, Drug and Cosmetic Act’s new-drug approval requirements and the First Amendment can be reconciled under a disclaimer-based regime that reflects the notion that patient care is advanced, rather than undermined, by accurate off-label information. In granting Amarin’s motion, the court declared that:

  • Amarin could promote its drug Vascepa (icosapent ethyl) for the off-label indication of treating patients with persistently high triglycerides, without that speech forming the basis of a misbranding prosecution; and
  • Amarin’s specific proposed statements (with accompanying contextual information as modified by the court) were truthful and non-misleading.

Notably, the court authorised Amarin’s proposed use of a qualified coronary heart disease risk-reduction statement, which the FDA had concluded that Amarin could not make for Vascepa based on the FDA’s conclusion that such a statement would be potentially misleading. The court rejected the FDA’s position and rationale, concluding instead that the statement (accompanied with a disclaimer) is “undisputedly an accurate account of the current state of scientific research”. The court also permitted Amarin’s proposed summary of a clinical trial designed to test the effectiveness of Vascepa in treating persistently high triglyceride levels, describing Amarin’s dissemination of the study and its results “as neither false nor misleading”.
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