District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

Wilson Sonsini Goodrich & Rosati

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin1 opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved drugs constitutes protected First Amendment speech.


For years, the FDA has taken the position that a drug or medical device manufacturer who proactively promotes an approved product for an unapproved (off-label, or unlabeled) use violates the Federal Food, Drug, and Cosmetic Act (FDCA). According to the agency, such off-label promotion misbrands2 the product. A misbranding conviction can result in up to one year of imprisonment and a fine of up to $1,000 per occurrence.3 If the misbranding is done with an intent to defraud or mislead, the term of imprisonment can be up to three years, and a fine of up to $10,000 is authorized.4

Under the law, a product is misbranded if it does not contain adequate directions for use,5 e.g., directions "under which [a] lay [person] can safely use a [product] for the purposes for which it is intended."6 Intended use, in turn, can be demonstrated by "oral or written statements by [companies] or their representatives . . ."7 which can include promotional labeling and advertisements and statements by the company or its representatives. Off-label statements and promotion may constitute evidence of intended use of a product that the FDA has not approved. Until the FDA approves a new use (e.g., for a new condition or indication, a new dosage, or dosing schedule), the FDA generally takes the position that a manufacturer may not proactively promote the product for the non-approved use.8

Off-label promotion can carry significant consequences under other laws, including the False Claims Act:

  • In 2012, GlaxoSmithKline plead guilty to introducing two misbranded drugs (Paxil and Wellbutrin) into interstate commerce and paid a $1 billion fine and forfeiture.
  • In 2012, Abbott Laboratories plead guilty to misbranding the drug Depakote and paid a $500 million fine.
  • In 2010, Allergan plead guilty to misbranding Botox and paid a $375 million fine.

Thus, the consequences for misbranding can be criminally and financially significant.


Amarin sought to proactively promote off label its FDA-approved drug Vascepa9 for lowering triglycerides (TGs) in patients having TG levels between 200 and 499 mg/dL of blood and who are already on statin therapy—an unapproved and off-label use.10 Vasecpa's ability to safely lower triglycerides in this patient population was undisputed and confirmed by the FDA.11 However, after reviewing Amarin's New Drug Application, or NDA, and the clinical trial data to support approval for this new indication, the FDA determined that there was substantial uncertainty regarding whether reducing triglyceride levels in this patient population would significantly reduce the risk of cardiovascular events in these patients. Consequently, the FDA rejected Amarin's NDA for this new indication. In its complete response letter, the FDA affirmatively warned Amarin that Vascepa "may be considered to be misbranded . . . if it is marketed [for this indication] without approval of [a] supplemental application."12

Amarin sued the FDA in district court, requesting preliminary relief on First Amendment grounds: Amarin wished to proactively make truthful non-misleading statements to doctors regarding Vascepa but was inhibited from doing so by FDA's threat to bring a misbranding action based on the off-label promotion.13 Amarin asked the district court to recognize that "FDA's prohibition on 'off-label' promotion, as applied to the truthful and non-misleading speech Amarin wished to make, were unconstitutional under the First Amendment, and that Amarin may engage in truthful and non-misleading speech to doctors about Vascepa free from the risk of criminal prosecution even if such speech constitutes off-label promotion."14 Amarin's complaint noted that its request fell within earlier precedent, where a federal appeals court held, among other things, that to avoid infringing the First Amendment, the misbranding provisions of the FDCA must be construed as "not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs" where the off-label use itself is lawful.15,16

In response, the FDA attempted to compromise proposing to allow Amarin to engage in some off-label promotion, while still reserving the right to pursue charges on any Amarin off-label promotion falling outside of the compromise. The agency also asserted that the earlier federal appeals court precedent in Caronia was fact constrained and to be narrowly construed.

In rejecting the FDA's position on all counts, the district court held that its "considered and firm view is that [under Caronia], the FDA may not bring [a misbranding] action based on truthful promotional speech alone, consistent with the First Amendment."17 The district court noted that a "fair reading of that decision refutes the FDA's view that the [Appellate Court's] ruling was limited to the facts of [the] particular case."18 "This Court therefore rejects the FDA's reading of Caronia as a mere artifact of that case's particular facts and circumstances."19,20

The court held that "Amarin's proposed communications, as modified herein, are presently truthful and non-misleading."21 However, the district court cautioned that a "statement that is fair and balanced today may become otherwise misleading in the future as new studies are done and new data is acquired."22 The district court also noted that "Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading."23 The district court therefore granted Amarin's application for preliminary relief, declared that Amarin "may engage in truthful and non-misleading speech promoting the off-label use of Vascepa," and that Amarin's proposed communications, with some court required modifications, are "truthful and non-misleading."24

Important Questions Still Remain

In the wake of Amarin, several questions remain. First, will the FDA appeal the Amarin decision? If it does so, it appears (based on the analysis in Amarin and Caronia) that FDA has a significant chance of losing on appeal.25 Second, will the agency issue new guidance comporting with these holdings? Third, what is the overall impact of these decisions—which apply to truthful and non-misleading off-label promotion of lawfully approved drugs and medical devices? The FDA can still pursue false or misleading off-label promotion without apparent encumbrance by the holdings of these cases. Also, going forward, drug and device makers must still try to determine what constitutes truthful and non-misleading speech, especially in light of the Amarin court's warning that this could change over time and with new facts. Additionally, what are the impacts of these decisions on the False Claims Act? Finally, the question remains to what extent drug and device manufacturers will change their promotional strategies, and the degree to which the FDA will be willing to work with the regulated industry to ensure promotional practices are truthful and not misleading.26

Off-label promotion is an evolving area of law fraught with opportunities and pitfalls, including substantial fines and criminal sanctions.


1 Amarin Pharma, Inc. v. U.S. Food and Drug Administration, 1:15-cv-03588-PAE (SDNY 2015).

2 See 21 U.S.C. § 333(a)(1).

3 Id.

4 See 21 U.S.C. § 333(a)(2)

5 See 21 U.S.C. § 352(f).

6 21 C.F.R. § 201.5.

7 21 C.F.R. § 201.128.

8 See 21 C.F.R. § 314.70.

9 Vascepa contains pure eicosapentaenoic acid (EPA), an omega-3 fatty acid found in fish oil.

10 Amarin at pg. 20.

11 Id.

12 Id. at page 26 (external citation omitted).

13 Id.

14 Id. at pg. 28.

15 United States v. Caronia, 703 F.3d 149, 168 (2d Cir. 2012). Hereinafter Caronia.

16 Amarin also submitted to the court specific statements and article reprints it intended to use to ensure its off-label promotion was truthful and non-misleading.

17 Amarin at pg. 45.

18 Id.

19 Id. at Pg. 48.

20 The district court also noted that FDA failed to appeal the Caronia decision, so it is law.

21 Amarin at pg. 66.

22 Id.

23 Id.

24 Id. at pg. 69.

25 The authors caution that appeals courts other than the Second Circuit may hold differently than the Caronia court when faced with similar facts.

26 The authors note that off-label promotional speech also applies to medical devices.


Written by:

Wilson Sonsini Goodrich & Rosati

Wilson Sonsini Goodrich & Rosati on:

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