ANVISA e o uso off-label de medicamentos: as relações entre evidência e regulação

Abstract

This thesis aims to discuss the relations between the off-label use of medicine and the regulatory procedures by Anvisa. The off-label use is any use and purpose other than that approved in the product registration, a different dosage, posology, route of administration, indication or group of patients. While it is an unavoidable reality in modern health systems, off-label medical prescriptions should meet the needs of a single patient, but eventually results in a medical error. There is no specific regulation for off-label use in Brazil so far, and this situation raises issues especially about the ethical, legal and regulatory implications involved. Understanding the off-label use of medicines is harmonized among the main regulatory agencies, the difference lies in the regulatory treatment given, which in the case of Brazil is not consolidated yet. In this pathway of clarifying the relationship between evidence and regulation regarding the off-label use of drugs within Anvisa, drug redirection arises as a valid strategy that aims to assign new uses to existing, in use or obsolete drugs. The first proposal of regulation on this subject is being presented in this thesis in the form of Technical Note, a regulatory path of mediation and for the moment, necessary and enough.