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Off-Label Promotion and Product Liability Considerations

By Alan Minsk

Much has been written, including by us in January 2016, about the Food and Drug Administration's (FDA's) court losses in the area of off-label promotion (e.g., promotion of a pharmaceutical product's unapproved uses). The agency held a public meeting in November 2016, and it is unclear how and when the FDA will issue any guidance, if at all, on its enforcement policy toward off-label promotion. Nevertheless, companies must remember that the agency will continue to take enforcement action, as appropriate, and FDA enforcement letters are made publicly available on its website. As such, non-compliance with FDA rules increases product liability exposure. In addition, even if the agency does not act, inaction does not preclude a product liability claim if someone is injured as a result of an unapproved use promoted by the company.

Herein, we provide an update on the current regulatory landscape in the off-label promotional area and also review potential liability risks for companies to consider. We conclude with recommendations to reduce these risks.

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