## Facts

- Amarin Pharma, Inc. marketed Vascepa (icosapent ethyl), a triglyceride-lowering prescription drug.
- FDA approved Vascepa in 2012 only for adults with very high triglycerides (≥ 500 mg/dL).
- Amarin ran the ANCHOR Phase III trial in patients with persistently high triglycerides (200–499 mg/dL) on statins; endpoints showed triglyceride reduction without raising LDL.
- Amarin sought a labeling expansion for that population; FDA denied approval in 2015, citing uncertainty that triglyceride reduction would reduce cardiovascular events.
- FDA warned that marketing Vascepa with information about the ANCHOR results or the unapproved indication could support enforcement for “misbranding” under the FDCA.
- Amarin proposed to communicate to physicians: accurate ANCHOR summaries; qualified statements about supportive but not conclusive research; and disclosures that FDA had not approved the indication and that an outcomes trial was underway.
- Amarin sued for declaratory and injunctive relief and moved for a preliminary injunction to prevent FDA from bringing a misbranding action based solely on its proposed truthful, non-misleading speech.

## Issues

1. Whether the First Amendment permits FDA to base an FDCA misbranding prosecution solely on a manufacturer’s truthful, non-misleading promotional speech about off-label use of an approved drug.
2. Whether Amarin’s proposed statements to physicians, with court-required revisions and disclosures, were truthful and non-misleading such that they could not be used as the sole basis for misbranding enforcement.

## Decision

- The court granted Amarin’s motion for a preliminary injunction.
- The court declared that, consistent with controlling circuit precedent, truthful and non-misleading off-label promotional speech may not, by itself, form the basis of a misbranding prosecution.
- After reviewing and modifying Amarin’s proposed communications and requiring qualifying disclosures, the court found the resulting statements truthful and non-misleading based on the information then available.
- The court found likelihood of success on the merits, irreparable harm from chilled speech, a balance of hardships favoring Amarin, and that the public interest supported allowing accurate, appropriately qualified information to reach physicians.
- The court emphasized limits: FDA may proceed against false or misleading promotion and may use speech as evidence of intent where other misbranding elements exist; the ruling addressed only the vetted set of statements and disclosures.

## Legal Principles

- Commercial speech that is truthful and non-misleading receives First Amendment protection; government restrictions are subject to heightened scrutiny under commercial speech doctrine.
- FDCA misbranding provisions cannot constitutionally be applied so that truthful, non-misleading off-label promotion is treated as the offense itself.
- FDA may regulate and enforce against false, misleading, or inadequately qualified drug promotion and may consider promotional speech as evidence of intent in an otherwise valid enforcement theory.
- Whether off-label communications are protected depends on a fact-specific assessment of accuracy, context, and the adequacy of disclosures about approval status and limits of the evidence.
- Threatened enforcement that deters protected speech constitutes irreparable First Amendment harm supporting preliminary injunctive relief.

## Conclusion

The court preliminarily barred FDA from pursuing misbranding enforcement based solely on Amarin’s vetted, truthful, non-misleading off-label communications and held that, with required disclosures and revisions, the proposed statements could be disseminated to physicians without serving as the sole basis for misbranding prosecution.


Amarin Pharma, Inc. v. U.S. Food & Drug Admin., 119 F. Supp. 3d 196 (S.D.N.Y. 2015)