Physical Accessibility of Medicines in Countries Hosting Trials for FDA Approvals

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?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.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.

Corresponding Author: Jennifer E. Miller, PhD, General Internal Medicine, Yale School of Medicine, 367 Cedar St, 4th Floor, New Haven, CT 06510 (jennifer.e.miller@yale.edu).

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