119 F. Supp. 3d 196
S.D.N.Y.2015Background
- Amarin Pharma sought to promote Vascepa for an off‑label use (patients with triglycerides 200–499 mg/dL on statins). FDA had approved Vascepa only for very high triglycerides (>500 mg/dL).
- Amarin’s off‑label claims principally relied on the FDA‑approved ANCHOR study showing triglyceride and related biomarker reductions; FDA denied the supplemental indication in a Complete Response Letter (CRL) citing uncertainty whether triglyceride lowering reduces cardiovascular events.
- The CRL warned that marketing Vascepa for the unapproved use could render the product misbranded, creating a credible threat of misbranding enforcement against Amarin for off‑label promotion.
- Amarin sued under the First Amendment and sought preliminary relief to permit truthful, non‑misleading communications with physicians about Vascepa’s off‑label effects; it proposed specific statements, study summaries, reprints, and disclosures it would provide.
- The FDA relied on United States v. Caronia but argued Caronia is fact‑bound and that the government may still prosecute when truthful speech is used as evidence of intent to promote an unapproved use; FDA offered conditional safe‑harbor language (Woodcock Letter) which Amarin declined in full.
- The district court applied the Central Hudson commercial‑speech framework, followed Caronia, held Amarin had standing and irreparable harm, and granted preliminary relief: truthful, non‑misleading off‑label promotion cannot by itself support a misbranding prosecution, and the court approved a modified package of Amarin’s statements/disclosures.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether there is a live case/controversy and standing for a pre‑enforcement First Amendment challenge | Amarin: CRL and enforcement history create a credible, imminent threat chilling speech | FDA: Woodcock Letter largely moots dispute if Amarin accepts conditions; otherwise speculative | Court: Amarin has standing; Woodcock Letter narrowed but did not eliminate the credible threat |
| Whether Caronia precludes misbranding prosecutions based solely on truthful, non‑misleading promotional speech | Amarin: Under Caronia, FDCA misbranding provisions must be construed not to reach truthful off‑label promotion | FDA: Caronia is fact‑bound; government may still prosecute where speech is evidence of intent or where contextual promotional acts exist | Court: Caronia applies broadly — truthful, non‑misleading speech alone cannot be the actus reus for misbranding |
| Whether Amarin’s specific proposed statements, summaries, reprints, and disclosures are truthful and non‑misleading | Amarin: Proposed materials are drawn from the ANCHOR study and FDA materials and thus are accurate; proposed disclosure edits improve balance | FDA: Some disclosures or a dietary‑supplement CHD claim could be potentially misleading and need contextual qualifiers or restrictions on manner of dissemination | Court: Most materials (13 reprints, ANCHOR summary, Statements #2–3, most disclosures) are truthful; approved a modified combined disclosure #2 and a modified FDA disclosure #3; approved the CHD statement with an added caution about diet/statins |
| Scope of relief (proactive promotion and manner of dissemination) | Amarin: Seeks ability to initiate dialogues and proactively promote to physicians without being limited to FDA‑prescribed formats | FDA: Distinguishes unsolicited/public requests vs. proactive marketing and sales rep outreach; seeks to preserve ability to treat context/method as evidence of intent | Court: Under Caronia, the manner (proactive vs. responsive) does not change protection — truthful, non‑misleading promotional speech cannot by itself trigger a misbranding prosecution; FDA may act against false/misleading speech or non‑communicative promotional conduct |
Key Cases Cited
- United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (Second Circuit held FDCA misbranding provisions cannot criminalize truthful, non‑misleading off‑label promotion)
- Central Hudson Gas & Elec. v. Pub. Serv. Comm’n, 447 U.S. 557 (1980) (four‑part test for restrictions on commercial speech)
- Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (pharmaceutical marketing constitutes protected commercial speech)
- Winter v. Nat. Res. Def. Council, 555 U.S. 7 (2008) (standards for preliminary injunction including likelihood of success and irreparable harm)