All-In

Supercharging a New FDA: Marty Makary on Science, Power & Patients

with Marty Makary, FDA Commissioner
15 Jan 2026 12 min read 1h 8m
TL;DR

The FDA under Makary is executing 42 major reforms to compress drug approval timelines from 10-12 years to weeks, including eliminating redundant animal testing, moving to single pivotal trials, and implementing AI-driven continuous monitoring. He argues that unnecessary delays in drug approvals kill more people than rushed approvals, and that the U.S. must accelerate biotech innovation to compete with China, which is now capturing 42% of biotech licensing deals versus 5% three years ago.

Key Moments
Marty Makary
“why does it take 10 to 12 years for a new drug to come to market? We've become so lukewarm and passive accepting that horrible uh timeline that that has just become the status quo.”
Makary explaining the core problem he's addressing at the FDA
▶ 4:46
Marty Makary
“144 chimpanzees are used for a monoclonal antibody. By the way, it's it's — you're making me sick because this has always been from my point of view one of the most troubling bioethical concerns”
Host expressing shock at animal testing requirements that Makary is eliminating
▶ 14:58
Marty Makary
“There were 2,000 HR people at the FDA just before I got there. There were 1,500 IT people. And so, for a staff of how many total? 20,000 employees just before I got there.”
Makary detailing the organizational bloat he found and began restructuring
▶ 6:03
Marty Makary
“We announced just last month that we are going to go from a baseline default requirement of two pivotal trials for a drug to one pivotal trial for a drug. It's just math. You can achieve the same statistical power if you design one good clinical trial properly with a good control group.”
Explaining a major reform that saves $100-300 million per drug and accelerates timelines
▶ 14:11
Marty Makary
“I want to see continuous trials with endpoints in the cloud so that the reviewers are looking on to the endpoint. You don't do your freshman year of college and then submit a giant 50,000 page application to start your sophomore year”
Makary describing his vision for real-time, continuous drug monitoring instead of batch approvals
▶ 21:21
About Marty Makary
›
Marty Makary is the Commissioner of the FDA under the Trump administration, having been appointed after his prominent advocacy during the COVID-19 pandemic. A surgeon and public health researcher at Johns Hopkins, he has long focused on healthcare transparency, quality, and reform. He previously led efforts on hospital price transparency that resulted in an executive order, and is now driving major reforms to accelerate drug approvals and modernize FDA processes.
Takeaways
1
Eliminate redundant trials and animal testing Moving from two pivotal trials to one, eliminating chimpanzee studies for monoclonal antibodies, and replacing animal testing with computational modeling and organ-on-chip technology. This cuts R&D costs by $100-300M per drug, accelerates approval by years, and improves predictive accuracy—90% of drugs that pass animal studies fail in humans anyway.
2
Real-time continuous monitoring replaces batch reviews Instead of waiting for scheduled committee meetings and massive application submissions, implement cloud-based endpoints with Bayesian statistics to identify safety signals and efficacy in real-time. This allows drugs to be approved in weeks rather than months and immediately flags post-market safety issues before they become epidemics like opioids.
3
Restructure incentives and remove siloed bureaucracy The FDA's seven centers operated like separate governments with their own lawyers, press offices, and communication chains—files were physically carried between buildings rather than emailed. Centralizing services and aligning bonus structures to reward speed (not just caution) unlocked employee ideas and compressed approval timelines from 60+ days to 1 day for preliminary determinations.