The scope of this study is to review the legal aspects of off-label prescription in Brazil compared to the US regulatory environment, to verify whether or not it derives from the structure of the current administrative regulatory process. It involved a bibliographic study in English and Portuguese in public databases of legislation, articles, books and dissertations using the key words 'off-label,' 'health law,' 'health regulation,' with respective translations into English. In Brasil and the US, health surveillance institutions have no jurisdiction on medical practices and cannot restrict off-label prescriptions beyond educational campaigns. Indications of use are a recommendation of minimum safety and efficacy for product commercialization, but are not a restrictive factor in practice, which does not exonerate physicians from civil liability lawsuits. Public measures to restrict off-label prescriptions are more common in the control of the incentives and dissemination of information to the medical community. Off-label prescription is a risk-benefit assessment made by the clinician and the pros and cons are described in the literature. Brazilian legislation and its stance on the subject still lack greater investigation and subsequent measures.
Health surveillance; Off-label prescription; Health law; Health regulation