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Lawsuit challenges FDA’s authority to prevent off-label marketing

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2587 (Published 12 May 2015) Cite this as: BMJ 2015;350:h2587
  1. Owen Dyer
  1. 1Montreal

A legal challenge mounted by a Dublin based drug manufacturer could hamstring the US Food and Drug Administration in its efforts to prevent drug company sales representatives from promoting their products to treat conditions for which the drugs were not approved.

Amarin Corporation, manufacturer of icosapent ethyl (which it markets in the United States as Vascepa), a prescribed omega 3 fatty acid, argues that information about its product’s effectiveness in “off-label” indications, as long as it was truthful and not misleading, was protected as free speech under the First Amendment to the US Constitution.

Off-label marketing has long been a bone of contention between the drug industry and the FDA. Physicians are allowed to prescribe off label, but drug makers are not allowed to recommend it. In the past 10 years at least 17 companies have paid a total of over $16bn (£10bn; €14bn) to settle claims of off-label marketing.

But in 2012 an appeals court reversed the conviction of Alfred Caronia, a sales representative for Orphan Medical, who had been recorded discussing off-label treatment options with physicians.1 …

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