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Off-Label Promotion and Product Liability
The pharmaceutical industry has recently felt empowered and emboldened by one final court decision and another pending case that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e. , off-label, so long as the information is truthful and not misleading. However, companies must, nevertheless, consider potential product liability ramifications. There is no indication that, because firms may now be allowed certain latitude in one area, they are immune from product liability exposure.
Amarin Pharma v. FDA
With Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. Aug. 5, 2015), the U.S. Food and Drug Administration (FDA) lost yet another court decision challenging its ability to restrict a company's commercial free speech rights. There, the U.S. District Court for the Southern District of New York granted Amarin's preliminary injunction to prohibit the FDA from taking enforcement action against the company's distribution of information about an unapproved use of its FDA-approved fish oil, triglyceride-lowering prescription drug product, Vascepa' (icosapent ethyl).
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