Notably, physicians regularly prescribed Vascepa precisely to this wider group of patients. Furthermore, FDA-approved studies had demonstrated the safety and efficacy of this off-label use. The FDA nevertheless rejected Amarin's request, warning that Vascepa "may be considered to be misbranded" under the FDCA if marketed for this particular off-label use. After receiving the FDA's misbranding warning, Amarin preemptively filed suit against the FDA. Amarin argued that the FDA violated the company's First Amendment rights by prohibiting it "from making completely truthful and non-misleading statements about its product to sophisticated healthcare professionals." Amarin, 119 F. Supp. 3d at 212 (internal quotation marks omitted). The FDA asserted that the agency could use speech as evidence of the intent (mens rea) and the act (actus rea) of misbranding. Id. at 223.