FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

by Reed Smith

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, the FDA filed a copy of a letter it had sent to Amarin outlining its position about the statements Amarin wants to make about its FDA-approved prescription drug, Vascepa.

Most recently, on June 23, 2015, the FDA filed its brief in response to Amarin’s Motion for Preliminary Injunction, along with declarations from several officials: Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration; Ellen London, Assistant U.S. Attorney for the Southern District of New York; and Curtis Rosebraugh, Director of the Office of Drug Evaluation II, Office of New Drugs, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration.

The FDA’s brief calls the lawsuit “a frontal assault by Plaintiffs on the framework for new drug approval,” rather than a narrow, as-applied constitutional challenge.  In the FDA’s view, because Amarin seeks an order allowing it to distribute Vascepa “under circumstances which could establish that Amarin intends an unapproved new use for Vascepa,” its success “has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

Consistent with its letter, the FDA’s brief also states that the “FDA does not object to most of Amarin’s proposed communications” and suggests that the issue before the court is quite limited:  whether the Agency could consider it to be evidence that the company intends a new unapproved use for Vascepa if Amarin does “distribute Vascepa for use by patients with ‘high’ (as opposed to ‘very high’) triglyceride levels who either have or are at risk of coronary heart disease and are already being treated with statins.”

In recounting the statutory and regulatory background, FDA explains that it could consider such evidence to violate federal statutes or regulations in three ways:

First, “if the claim is made in ‘labeling’ and establishes a new intended use, Vascepa would be considered an unapproved new drug with respect to that intended use, and distribution of Vascepa for that unapproved new use would therefore be prohibited. 21 U.S.C. §§ 331(d), 355(a), 321(g), (m) & (p).”

Second, evidence of a new intended use “may also establish a violation of the FDCA’s misbranding provisions” because a drug is misbranded if “it lacks adequate directions for all intended uses, and the interstate distribution of misbranded products is illegal.  See 21 U.S.C. §§ 331(a), (b), (c), (g) & (k).”

Third, “to the extent any of Amarin’s communications, when taken in context, are misleading,” they might constitute “‘false or misleading’ labeling, rendering Vascepa misbranded” under 21 U.S.C. § 352(a), and its distribution in interstate commerce prohibited, 21 U.S.C. §§ 331(a), or might “constitute advertising that is ‘false, lacking in fair balance, or otherwise misleading,’” and thus misbranded under 21 C.F.R. § 202.1(e)(6), 21 U.S.C. § 352(n), and 21 U.S.C. § 321(n).

Perhaps highlighting why manufacturers like Amarin feel the need to seek preemptive court guidance about what they can and cannot say, the FDA’s brief states at the same time that:

The FDCA’s reach does not extend to all communications by drug manufacturers about uses that have not been approved. The dissemination of information about an unapproved use would not, by itself, cause a violation of the FDCA when such information is neither false nor misleading, and is not relevant, or sufficient, to infer a new intended use.

Amarin’s lawsuit raises these First Amendment free speech issues in a uniquely interesting context, because the FDA’s position is that Amarin cannot make a heart disease claim for Vascepa as a drug (namely, that “[s]upportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease”), it could make this same heart disease claim for Vascepa if marketed as a nutritional supplement.  The FDA attributes this disparate treatment to the fact that “drugs present markedly different considerations from dietary supplements,” but it remains to be seen whether the court will find this distinction problematic from a constitutional standpoint.

More developments are sure to come.  Stay tuned.

Written by:

Reed Smith

Reed Smith on:

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