Michael S. Sinha, Aaron S. Kesselheim

First published May 8, 2018

For the past half-century in the United States, it has been widely recognized that, even though physicians can legally prescribe drugs for indications that the Food and Drug Administration (FDA) had not approved (“off-label” uses), pharmaceutical manufacturers could not proactively promote their products for such uses. This rule, which arises from language in the federal Food, Drug, and Cosmetic Act (FDCA) [1] that gives the FDA its authority [2], has numerous public health rationales [3]. Of primary concern is the fact that off-label prescribing can carry substantial risks of both ineffectiveness and even harm for patients; permitting promotion for such a purpose could lead pharmaceutical manufacturers to flood the market with biased and/or incomplete information that can sway prescribing practices. Recognizing that some off-label communication could be permissible, the FDA has enumerated safe harbors for manufacturers: responding to unsolicited questions from physicians, distributing peer-reviewed article reprints discussing these uses, and sponsoring impartial continuing medical education courses. Nonetheless, in the past three decades, tens of billions of dollars in civil and criminal penalties have been paid by nearly all major pharmaceutical manufacturers for engaging in off-label promotion outside these circumscribed areas [4], in each case leading to problematic consequences for patients (such as from the widespread, promotion-driven use of antipsychotics in elderly patients with dementia) [5].

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