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March 2016

Free Speech and Pharmaceutical Regulation—Fishy Business

Author Affiliations
  • 1Yale Law School, New Haven, Connecticut
JAMA Intern Med. 2016;176(3):295-296. doi:10.1001/jamainternmed.2015.8155

Recent research has not been kind to fish oil salesmen, or the value of ω-3 fatty acid supplements for the secondary prevention of cardiovascular disease.1 Amarin Corporation, in particular, has been hit hard. The company’s only approved product is icosapent ethyl (Vascepa), a prescription-based derivative of fish oil. In 2012, the US Food and Drug Administration (FDA) approved the drug to treat patients with very high triglyceride levels, but the company has long wanted to promote its use in a much larger group of patients: those with lower triglyceride levels and cardiovascular disease who were already being treated with statins. In 2013, an FDA advisory committee voted 9 to 2 against approval for this use, in part because several recent studies of other drugs with similar effects on blood lipids showed no clinical benefit when they were added to statins.2 Amarin’s stock price plummeted, and investors brought suit claiming that they had been misled about the promise of the drug.

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