The judicialization of immunotherapy drugs without registration with Anvisa: the case of the State of São Paulo, Brazil

• Autor(a) principal: de Oliveira, Daniel Buffone
• Data de Publicação: 2019
• Outros Autores: Silva, Rafael Augusto Mantovani, de Paula, Ellen Alves, Cassamassimo, Raphael Pereira, de Siqueira, Paula Sue Facundo, de Melo, Daniela Oliveira
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
• Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/571
• topic: Health's judicialization. Off-label use. Pharmaceutical services. Access to essential medicines and health technologies. Brazilian Health Surveillance Agency.; Judicialización de la salud. Uso fuera de lo indicado. Servicios farmacéuticos. Acceso a medicamentos esenciales y tecnologías sanitarias. Agencia Nacional de Vigilancia Sanitaria.; Judicialização da saúde. Uso off-label. Assistência farmacêutica. Acesso a medicamentos essenciais e tecnologias em saúde. Agência Nacional de Vigilância Sanitária.

Objectives: The drug approval minimally guarantees the safety in the label directions. With the judgment of Extraordinary Appeal No. 67718, this issue is not pacified. The aim of this study is to compare the indications approved by the American (FDA), European (EMA) and Brazilian (Anvisa) health agencies and to analyze data regarding the indication of immunotherapeutic drugs for cancer treatment, in lawsuits against the Secretary of State of Health of São Paulo (SES/SP). Methods: Documentary research was performed on the package leaflets of six immunotherapeutic drugs available in July 2019 on the websites of the health agencies eligible for the study, and comparing the indication of these drugs in lawsuits in the state of São Paulo, using data from reports. or scanned documents available on the S-Codes system. Results: All drugs are registered for at least one indication in the 3 health agencies, but with differences in the approved indications, many of them being conditional approvals (fast track). The average time between FDA and Anvisa approval was 464.5 ± 170.8 days, and 278 (98%) of the demands occurred post-registration with Anvisa. There is little information available in the scanned documents, but it was possible to identify situations involving indications as well as genetic test results. Discussion and Conclusion: analysis shows that the FDA tends to be less rigorous in approving new indications, and that most demands would not meet the criteria of RE 657718/2019. Despite the progress in discussions involving the judicialization of health, it is necessary to discuss the off-label use of these drugs and their specificity.