The man now running the Food and Drug Administration spent his career on the other side of the table from it, at the law firm Jones Day, defending food, beverage, and tobacco-industry clients against the kind of agency he now leads. Kyle Diamantas has never designed a drug or treated a patient. On September 15, his FDA announced a program to move experimental compounds toward their first human dose faster than it does today.
The vehicle is called the Expedited Investigational New Drug Pilot, and the agency began taking applications the same day. Companies have until October 30 to apply, and the FDA intends to select eight to ten sponsor-and-institution pairs for a first cohort. It is the operational front end of Operation TrialBlazer, the HHS roadmap unveiled in June to close the gap between how fast a new molecule reaches a human being in America and how fast it does everywhere else.
The mechanism is procedural, and it is not small. Today a sponsor assembles a complete IND application, submits it, and only then does the FDA begin to read. The pilot pairs the sponsor with what the agency calls a Qualified Research Institution, an outfit the FDA itself picks, and lets reviewers take the file in pieces as it arrives during the pre-IND phase, rather than waiting for all components to begin review. The promise is fewer surprises late: catch the problems early, avoid a clinical hold on the first-in-human protocol, get to that first dose sooner.
That pre-IND review is not paperwork. It is where the FDA retains, in its own words, responsibility for determining whether a clinical investigation may proceed, which is the decision to put a compound that has never been inside a person into one for the first time. That is the review the pilot is built to compress.
The case for speed is a competition case, not a patient one. First-in-human trials “may take up to two years to complete in the United States,” the announcement says, while “the same types of trials are completed much faster in China and Australia.” The gap is documented. By one analysis, Phase I trials run about 7 months in China against 17 in the United States, and Australia stays attractive partly because it has no IND requirement at all. Nobody serious disputes that the American clock runs slow.
| Measure | Value |
|---|---|
| China | 7 |
| United States | 17 |
Listen to the people running the pilot and you hear the vocabulary of a race. The acting commissioner says the priority is making sure “American patients have first access to groundbreaking treatments.” Karim Mikhail, who runs the biologics center, says the FDA is “doing our part to ensure American patients continue to receive access to therapies first.” Michael Davis, who runs the drug center, offers that the agency is committed to keeping the United States “the global standard for pharmaceutical innovation.” Every one of those lines is about winning; none is about the safety review the pilot exists to speed, the one that decides whether an untested drug can be given at all.
There is a tell in who is unenthusiastic. The Biotechnology Innovation Organization, the drug industry’s own lobby, raised doubts about whether any single research institution could meet the requirements the FDA set, and worried that funneling everything through a hand-picked QRI might add an additional layer of review rather than strip one away. When the trade group frets that a deregulatory favor could slow its own members down, the favor is worth reading twice.
None of which makes the competitiveness worry fake. Losing early-stage research to Beijing and to a country that requires no IND at all is a genuine sovereignty problem, and there is a real America First argument for keeping first-in-human work, with the jobs and the know-how attached to it, inside the United States. But that argument is not a blank check for whoever waves the flag with it. The fix on offer is to let sponsors feed their safety data to the agency on a rolling schedule, through institutions the agency selects, under a commissioner who spent two decades getting regulated industries out from under the regulator and, by STAT’s account, arrived with “no experience in public health, in medicine or science, or in government.” The nationalism is the wrapping. Underneath it is a speed favor to the companies whose drugs are on the clock, and the burden sits with the FDA to prove it is more than that.
The pilot will pair up to ten sponsors with institutions the agency itself chooses, to help build the safety files reviewers then read in pieces. Presiding over the arrangement is a man who has never run a clinical trial, never treated a patient, never designed a drug. He is, at least, an expert in the kind of document that sells a thing before anyone has proven it works.
Sources
- FDA – Launches Expedited IND Pilot, Begins Accepting Applications (Sept. 15, 2026)
- BioPharma Dive – FDA’s Operation TrialBlazer IND pilot; industry lobby’s concerns
- Clinical Trials Arena – Trial run: FDA launches pilot for expedited INDs; China 7 vs US 17 month Phase I
- STAT – Kyle Diamantas, acting FDA commissioner: background and prior industry clients