Healthcare Economist April 9, 2023
Pham et al. (2023) uses data on regulatory decisions and health technology assessments (HTAs) in Australia, Canada, and the UK and compares them to the drugs that are FDA-approved in the US. They find that:
The FDA approved 206 new drugs in 2017 through 2020, of which 162 (78.6%) were granted marketing authorization by at least 1 other regulatory agency at a median (IQR) delay of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved drugs were refused marketing authorization by an international regulatory agency due...