Key Points
Question Are medicines physically accessible in the countries where they are tested for US Food and Drug Administration (FDA) approval, and has physical access improved over time?
Findings In this cross-sectional study of 172 medicines approved by the FDA from 2015 to 2018 and tested in 89 countries, 24% were physically accessible in all countries where they were tested 5 years after FDA approval. Countries in Western Europe had notably better access (82%) than countries in Africa (28%), with no improvements over time for low- and middle-income countries.
Meaning Most countries participating in trials for FDA approvals cannot physically access the medicines they test, particularly low- and middle-income countries, raising exploitation concerns, with no improvements over time.
Importance Populations participating in clinical trials should stand to benefit from resulting interventions, according to ethical guidance. Yet, our studies show low- and middle-income countries (LMICs) participating in trials for US Food and Drug Administration (FDA) approvals lack timely access to the medicines they help test, raising exploitation concerns.
See full study in JAMA IM here.