Just this week, I blogged about the FDA’s letter and opposition in response to Amarin Pharma, Inc.’s complaint challenging regulations that prohibit the distribution of “off-label” information.  See June 30 Blog.  On Tuesday, the pharmaceutical company filed a reply in response, attacking the FDA’s actions, claiming that the FDA’s June 5th letter and opposition are all too “familiar to students of its prior behavior,” which Amarin claims is to “escape [] First Amendment-centered judicial review[.]”  Specifically, Amarin states that “[n]othing in the FDA’s June 5 letter to Amarin or in its brief…recognizes the company’s First Amendment right to do or say any of [the] things” it sought to do in its Complaint.  Although acknowledging the “inherent tension between the FDA’s interest in protecting patients” while at the same time “ensuring that drugs meet FDA’s ‘gold standard[,]’” Amarin argues that such tension is “not a basis for limiting First Amendment-protected free speech.”

Although the FDA claimed in its opposition that the majority of the issues alleged are no longer viable in light of its recent letter, Amarin argues that the issues involved are “far more” than the FDA asserts and do, in fact, present a live controversy.  In doing so, Amarin relies on the FDA’s recent “Complete Response Letter,” which informed Amarin that it could face prosecution under the FDCA’s “misbranding” provisions if Vascepa is marketed for off-label use.  Furthermore, Amarin emphasizes that even the FDA’s June 5th letter “reasserted” the FDA’s authority to pursue “misbranding prosecutions for off-label promotion.”  Moreover, Amarin asserts that the only thing the June 5th letter made clear was that Amarin can only “safely” engage in its proposed conduct on the FDA’s terms, which is “inconsistent with the First Amendment.”

Amarin argues it is entitled to a preliminary injunction because the FDA regulations threaten the company’s speech, which cannot survive First Amendment scrutiny.  Specifically, Amarin asserts that the FDA’s defense of “speech-as evidence” only – claiming that the regulations do not actually prohibit speech – is “on its face, a charade.”  Critically, Amarin explains that the FDA acknowledges that the conduct to which off label promotion is directed – the actual use of an off-label drug – is lawful and in fact, “truly medically necessary.”  Thus, Amarin argues that the “illegal” conduct for which speech is used as “evidence” is clearly “nothing but the speech itself.”  In fact, Amarin goes so far as to state that the “most obvious way to address the FDA’s concern about off-label drug use would be….to do so ‘directly’ by simply banning such use” (but obviously emphasizing that Amarin “hardly favors” such a ban).

Amarin further argues that its qualified health claim – that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” is “commercial speech protected by the First Amendment if presented in a way that is not deceptive.”  Critically, the FDA claims that Amarin’s statement would, in fact, be truthful and non-misleading if Vascepa were marketed as a dietary supplement versus a drug.  But, Amarin stresses that its claim is “far less likely to mislead” when made to “sophisticated doctors,” especially where the statement would only be made with the disclosure that the FDA has not specifically approved the drug for such use.

With respect to Amarin’s argument that the FDA’s regulations are unconstitutionally vague, Amarin emphasizes that the FDA has still “not made at all clear” what promotional activities are acceptable with respect to off-label use that would not subject manufacturers to potential criminal sanctions.  Amarin urges that such “uncertainty, coupled with credible threats” is “constitutionally unacceptable.”  Lastly, with respect to the False Claims Act, Amarin reiterates that protected speech cannot be used as a basis for civil liability.  Notably, the company emphasizes that the Government has already obtained “billions of dollars from drug companies by bringing claims under the False Claims Act for alleged off-label promotion.”  The company urges that such a ruling “would be devastating to a small company like Amarin.”