Supercharging a New FDA: Marty Makary on Science, Power & Patients
What this video covers
In this January 2026 episode of the All-In Podcast, the hosts interview then-FDA Commissioner Marty Makary — who would resign four months later, on May 12, 2026 — about what the episode frames as “supercharging” the agency.
Makary walks through what he describes as 42 major FDA reforms in 10 months, the race with China for biotech leadership, and how he says clinical trial timelines can be cut without sacrificing safety. Specifics stand out: he says Trump called him days after the election to offer the job; that the agency went from talking about banning one food dye for 35 years to removing all nine within weeks of his arrival; and that rejection letters are now public after “they talked about it for 30 years.” He claims no scientific reviewers were laid off in the staffing cuts — 2,000 HR and 1,500 IT staff out of 20,000 — and that turnover stayed at the baseline 5–7% while the agency hired 1,500 new scientists.
On reforming trials, he says the FDA moved from a default of two pivotal trials to one, saving companies $100–300 million; dropped chimpanzee-study requirements for monoclonal antibodies (typically 144 chimps per drug); and argues 90% of drugs that pass animal studies fail in humans. He frames the US-China biotech race with data: China’s share of licensing deals rose from 5% in 2022 to 42% in 2025, and China runs phase-1 trials in four weeks versus the FDA’s 60 days just to acknowledge a supplemental application. He cites his own survey at Johns Hopkins that took a year and a half in IRB review without approval as an example of what’s broken.
The conversation covers reshaping the federal food pyramid, GLP-1 drugs and the obesity epidemic, and rethinking vaccines “from first principles.” He reports that the priority-review pilot had 18 products with vouchers, the first approved in 55 days, and that the FDA hit 100% of its 2025 user-fee target dates with a record nine drug approvals in one month from the biologics center. Looking back at the pandemic, he calls the denial of natural immunity “one of the most scientifically dishonest things a scientist could possibly say” and lists cloth masks on toddlers, college booster mandates, and two years of school closures as the dogma he fought.
The All-In format is freewheeling and tech-industry-inflected, giving Makary one of his longest unscripted platforms as commissioner.
Key points
- Makary claims 42 major FDA reforms in his first 10 months at the agency.
- He discusses competing with China for leadership in biotechnology.
- He argues clinical trial timelines can be shortened safely, including via new trial designs.
- He covers the food pyramid overhaul, GLP-1s and obesity, and a “first principles” rethink of vaccines.
- He addresses drug pricing and AI’s role in healthcare.
- He shares his views on the causes of autism, a topic of intense public interest.