Real-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM.

PURPOSE: We studied under which circumstances and to what extent Real-World Data (RWD) and Real-World Evidence (RWE) were used in regulatory decisions when switching products from Prescription-only (Rx) to Over-the-Counter (OTC) status with the aim of extracting learnings that could be applied in future switches. METHODS: Sanofi commissioned Clarivate Analytics to identify switches from Rx to OTC in the European Union (centrally by the European Medicines Agency [EMA] and in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]), in the United States by the Food and Drug Administration (FDA), and in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) as far back as data were available in the public domain, mainly Health Authority webpages. They covered the period from and including 2022 and went as far back as they could find data in their proprietary database or in the public domain; for the EMA back to 2008, the US FDA back to 2001, the UK MHRA back to 1991, and the German BfArM for the period 2013-2022. We also asked Clarivate to investigate the nature of acceptance of RWD and RWE, and to what extent they are accepted by the different regulators in their decision-making and approval processes. FINDINGS: We found that the number of drugs available in the OTC segment is higher in regulatory jurisdictions where OTC policies are clear and supplemented by guidelines and transparent decision-making processes at the regulator level. A wide range of different data sources, many of which can be regarded as RWD/RWE in their broadest definitions, have been used to support switches. The data required by regulators to support a switch from Rx-only to OTC availability primarily centers on drug safety-both the drug's intrinsic safety and the safety associated with consumer usage. IMPLICATIONS: Clear and transparent regulatory switch frameworks are conducive to growing the number of medicines available to consumers willing to self-manage their conditions. Transparent disclosure of the RWD and RWE data sets that regulators have found acceptable in historic switch applications is desirable because it would help sponsors to facilitate and increase prospective switches, thereby benefiting patients and society.