Amarin settlement paves way for “off-label” promotion of omega-3 product.

• The pharmaceutical industry has been awaiting the resolution of the groundbreaking Amarin case.  At the heart of the case is Amarin’s marketing of Vascepa, an omega-3 drug product, as effective in treating patients with “persistently high” triglyceride levels, as compared to the “very high” level specified in FDA’s approval.  FDA took the position that such marketing practices constituted impermissible “off-label” promotion, but a New York federal judge ruled last year that the company had a First Amendment right to provide doctors with truthful and non-misleading information about the drug’s efficacy.

• On March 8, Amarin and FDA reached a settlement to close the case, under which Amarin will be permitted to engage in truthful and non-misleading speech promoting the off-label use of Vascepa.  The settlement also provides for dispute resolution procedures and a special consultation process in which FDA will pre-review up to two promotional pieces per year for off-label uses of Vascepa.

• The Amarin case is being hailed as a First Amendment victory for the pharmaceutical industry, but its wider implications remain to be seen.  FDA maintains that the settlement applies only to the Amarin case and its unique facts, which included particularly high-quality substantiation for the off-label use at issue.  Without a doubt, the Amarin case is precedential for the pharmaceutical industry, the Agency, and the judiciary.  At the very least, this case represents a chink in FDA’s armor and confirms that at least certain types of off-label promotion warrant constitutional protection.