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

The conversation takes place in San Francisco during the J.P. Morgan Healthcare Conference, described as probably the biggest biotech conference globally, with 120,000 attendees. The opening introduces Marty Makary (transcribed as "Marty McCarrie") as Commissioner of the FDA, nearly a year into the role.

Asked how the appointment came about, the account traces an academic and clinical career: graduate training in public health, a faculty post at the Johns Hopkins School of Public Health, and a clinical practice in GI and cancer surgery at Johns Hopkins. The stated long-running interest was the root causes of healthcare system problems, namely quality, transparency and price. Work on hospital price transparency led to a well-selling book, an invitation to the White House during the first Trump administration, and a hospital price transparency executive order signed by the president. Those relationships, the account says, led to a call days after the 2024 re-election and the offer of the FDA role.

The COVID period is presented as a case study in what the speaker calls entrenched medical orthodoxy, with paternalism and the suppression of non-legacy ideas cited as problems that persist. The account frames it this way:

the sort of sociology of medical dogma is a fascinating historical thing.

Specific policies criticized: cloth masks on toddlers for three years; vaccine mandates for young college students; recommending COVID boosters "with such absolutism" for young healthy children; ignoring natural immunity, called one of the most scientifically dishonest positions scientists took; and keeping children out of school for nearly two years.

The speaker says they fought school closures alongside others starting in fall 2020. They accept that acting before the virus was understood was reasonable at first, but argue that once data emerged, the case for reopening was strong. They concede that "to some degree" that battle was lost, while claiming the data has since caught up with public health officials. They describe their current role as part of an effort to rebuild public trust in health institutions.

A question raises the conflict that comes from rewriting how institutions operate and diminishing the authority some people built in those roles. In response, the speaker describes a method for surfacing ideas internally. Briefings held with supervisors in the room produce one version of events. One-on-one meetings that give individual scientific reviewers anonymity produce candor. Four out of five people or more offer nothing especially interesting, but some identify practices that make no sense and propose better ones they would not raise in front of a supervisor.

The account says 42 major reforms have been announced in 10 months, and it presents them as a challenge to the status quo, driven by the drug development timeline:

why does it take 10 to 12 years for a new drug to come to market?

Examples offered: new programs, priority reviews, pilots and forms of transparency; publishing the agency's rejection letters, so the public learns why a drug was not approved, which the speaker says had been discussed for 30 years; and action, within weeks of taking office, to remove artificial petroleum-based food dyes, after the speaker says a ban on one dye had been discussed for 35 years.

The questioner notes that some former FDA employees have become outspoken critics who describe chaos and turmoil, and compares fast-moving startups, which can feel overwhelming, to the view that progress is what matters. The response gives figures. Just before the speaker arrived, the agency had about 20,000 employees, including 2,000 HR staff and 1,500 IT staff. The goal was to return to 2019 staffing levels, with cuts falling on HR, procurement, IT and duplicative services. The speaker states that no scientific reviewer was laid off and acknowledges that such moves carry "headline risk." They say they arrived right after this restructuring.

The speaker contrasts their agenda with the previous commissioner's stated top priority of fighting misinformation:

Well, my number one priority is not to censor Americans, it's to deliver more cures and meaningful treatments faster to the American public and healthier food for children.

To rebut claims of an exodus, the speaker cites a turnover rate at the agencies' 10-year baseline of 5 to 7 percent and says the agency is hiring 1,050 new scientists to staff new accelerated pathways. The excerpt presents these figures as assertions; no supporting data is shown, and the critics' specific claims are not described in detail.

The questioner frames the biotech discussion around competition with China and cites a report from the Congressional National Security Commission on Emerging Biotechnology, which they say gives the US a three-year window to keep pace with Chinese biotech innovation and speed.

Figures cited by the questioner: Chinese companies accounted for 5% of licensing deals in 2022 and 42% in 2025; a recent deal between 3S bio and Pfizer involved 1.25 billion up front and $6 billion in total; and ten years ago China produced only 50% as many published scientific papers as the US, while today it produces 50% more.

The speaker agrees there is a race and says the US was losing it on arrival, falling behind China, Australia and others that operate with less red tape. Some protective measures are possible, but the core answer is to become more competitive on early-stage work, phase one trials and investigational new drug filings, rather than rely only on protectionist strategies.

Part of the bottleneck, the speaker argues, sits outside the FDA. Hospital institutional review boards (IRBs) that approve research meet monthly. In an anecdote from Johns Hopkins, a nutrition survey study spent a year and a half in IRB review and was still not approved. The speaker contrasts this with China, said to run phase one trials in four weeks, and Australia, in six weeks. Contracting is another obstacle: each US hospital negotiates its own margin and customizes contracts, while in Australia a single signature gives access to around 14 hospitals. The stated priorities are more centralized IRBs and centralized hospital contracting.

Within the agency, the speaker says it took 60 days for the FDA to say whether it would consider a supplemental application, and it often still takes 60 days to confirm that an application is complete. The stated goal is to cut that to one day using AI.

Asked how much can be done without legislation, the speaker explains that applicants pay user fees when they submit applications. Their preferred change is higher user fees when phase one trials are run overseas and lower ones when they are run in the United States, which they call an "America First Policy." They would welcome congressional action but say they will not wait for it, describing Congress as slow.

The speaker says the first priority after the restructuring was morale, culture and timeliness. They report that in 2025 the agency hit 100% of its user-fee target dates, and that every accept or reject decision matched the primary review team's recommendation. They present this as evidence of no "secret deals" and of standing by agency scientists. They also cite a record number of approvals last month at the Center for Biologics, including cell and gene therapies.

For a general audience, the speaker outlines the process. An investigational new drug (IND) registration comes first, and most are filed by academics, a reminder that much innovation happens outside pharma labs. Phase one tests a drug in a small number of healthy subjects. Phase two is a limited study in people with the condition. Phase three is a large randomized controlled trial known as the pivotal trial.

The speaker says the FDA announced last month that the default requirement would drop from two pivotal trials to one, arguing:

It's just math. You can achieve the same statistical power if you design one good clinical trial properly with a good control group.