Commissioner Makary’s reflections on his first 100 days at the FDA
In his first 100 days as Commissioner, U.S. Food and Drug Administration Commissioner Martin Makary outlined a major push to modernise the FDA and accelerate access to treatments.
Initial goals for the FDA Commissioner:
- Streamline agency
- More cures and other meaningful treatments for Americans
- More powerful diagnostics
- Better processes
- Better food for children
- Streamlined inspections
- More domestic manufacturing
- Support national priorities
Notable accomplishments in the first 100 days include:
- launch of internal AI tool (releasing 2.0 later this month)
- introducing the new Commissioner’s National Priority Voucher (CNPV) programme designed to speed up drug reviews.
- reducing animal testing requirements
- improving communication with industry
- release of Complete Response Letters
- removal of petroleum food dyes
A major theme he wanted to tackle is competitiveness and national security. Makary warned that Chinese biotech companies are moving into early-stage clinical trials at “lightning speed,” often by modifying existing intellectual property, before those assets are later acquired by American pharmaceutical companies. His view was that if the U.S. wants to remain competitive, the FDA needs faster, more flexible regulatory processes.
The discussion also touched on priorities including domestic manufacturing, long COVID, youth vaping, and continuing efforts to reduce time-to-market for effective treatments.
Within the next 100 days, the Commissioner is focused on continuing to support staff with modernization, improve processes and continue to work to improve time to market for effective treatments.
