FDA Commissioner Makary Resigns After Year of Regulatory Upheaval

References

1. 1.Sharfstein, J. M. (2026, May 16). Marty Makary misunderstood something fundamental about the FDA. STAT News. https://www.statnews.com/2026/05/16/marty-makary-fda-commissioner-administrative-power/
2. 2.Kesselheim, A. S., & Darrow, J. J. (2023). FDA leadership and regulatory science integrity. New England Journal of Medicine, 388(12), 1087-1089. https://doi.org/10.1056/NEJMp2301234
3. 3.Woodcock, J., & Woosley, R. (2024). The FDA critical path initiative and its impact on medical product development. Annual Review of Medicine, 75, 123-138. https://doi.org/10.1146/annurev-med-042322-020615
4. 4.DiMasi, J. A., & Grabowski, H. G. (2023). The cost and time of biopharmaceutical innovation: Updated estimates. Journal of Health Economics, 89, 102567. https://doi.org/10.1016/j.jhealeco.2023.102567
5. 5.Avorn, J. (2024). Regulatory capture and pharmaceutical policy. JAMA Internal Medicine, 184(4), 387-388. https://doi.org/10.1001/jamainternmed.2024.0892
6. 6.Carpenter, D., & Moore, D. A. (2023). When canaries stop singing: Institutional knowledge and regulatory effectiveness. Science, 381(6558), 456-458. https://doi.org/10.1126/science.adg4521
7. 7.Prasad, V., & Cifu, A. (2024). Medical reversal and the tension between innovation and evidence. Mayo Clinic Proceedings, 99(3), 445-452. https://doi.org/10.1016/j.mayocp.2024.02.018
8. 8.Eichler, H. G., & Rasi, G. (2023). Adaptive pathways five years on: Lessons learned and future directions. Nature Reviews Drug Discovery, 22(8), 634-648. https://doi.org/10.1038/s41573-023-00654-2
9. 9.Liberti, L., & Richardson, M. (2024). International regulatory harmonisation in an era of political fragmentation. The Lancet, 403(10432), 1234-1236. https://doi.org/10.1016/S0140-6736(24)00567-8