Can States Outperform the FDA? Montana, Right to Try, and Biotech Federalism
Matt Kaeberlein sits down with Infinita CEO Nicholas Azinger to debate whether individual states should play a larger role in regulating experimental therapies. Azinger argues for 'biotech federalism' and points to Montana's new Right to Try framework, while Kaeberlein voices real concerns about 50 different systems creating confusion. It is a thoughtful, respectful conversation about a system almost everyone agrees is too slow and too expensive.
Overview
In this Longevity Policy conversation, biologist Matt Kaeberlein hosts Nicholas Azinger, CEO of Infinita, one of the organizations helping implement Montana's new Right to Try framework. Kaeberlein opens with a disclosure that he serves on one of Montana's Experimental Treatment Review Boards, then explores Azinger's vision of 'biotech federalism' — letting states act as laboratories for medical innovation.
Azinger frames the core problem as the cost and slowness of generating evidence, noting that a new drug can take over a decade and roughly a billion dollars. They discuss why offshore trials in places like Prospera struggle with perception and data credibility, and why a regulated U.S. state like Montana could build institutional trust through review boards that mirror an IRB. A surprising thread is how conventional randomized trials often exclude patients with comorbidities, producing data that may not reflect the real-world population.
The two also examine the funding 'catch-22' facing early biotech, global competition from China and Australia, and where federal law and interstate commerce still apply. Kaeberlein pushes back throughout, drawing on the messy reality of state-by-state medical licensing, while both agree the current system needs reform. They close on a shared hope that Montana could become a model that scales through portable standards rather than fragmentation.
Key quotes
5Up until the 1960s, if we invested a billion we got 100 new drugs, and now we get less than one for a billion.
Reality is one thing, but in these situations perception is what really matters.
You know what that makes patients do that really want to do the trial? It makes them lie.
There's no solution only trade-offs.
Let the FDA do less, but let it do it better.
Key ideas
8The central question: states versus the FDA
Should states play a larger role in regulating experimental medicines? Kaeberlein frames the trade-off between faster state-level innovation and the risk of 50 different systems creating confusion and less confidence in the evidence.
Drug development has become slow and expensive
Azinger argues the core problem is the cost and speed of generating evidence. Where a billion dollars once yielded around 100 new drugs, today it can yield less than one, even as tools like computational biology have advanced.
The offshore perception problem
Azinger describes special economic zones like Prospera in Honduras, where looser rules attracted early longevity trials. He concedes the 'offshore' label is hard to shake, which is part of why building credibility inside the United States matters.
Adverse-event reporting and enforcement
The pair debate how any system truly knows that clinics report side effects. Both jurisdictions rely on legal requirements and insurance, but confidence depends on a track record of real enforcement over many years.
Montana's framework mirrors an IRB
Montana's Experimental Treatment Review Boards are designed for institutional legibility, echoing the structure of an Institutional Review Board. Review boards, licensed treatment centers, and hospital adoption are meant to build accountability and trust.
Trial populations may not reflect real patients
Azinger notes that randomized trials often exclude people with comorbidities, so only a small share of real patients qualify. Approved drugs can then underperform in the real world where those confounding factors exist.
The biotech funding catch-22
After a small phase-one trial, companies struggle to raise the tens of millions needed for phase two or three without more data. Early state-level access programs could generate additional outcome signals to help de-risk and fund the next stage.
Federal law, interstate commerce, and China
Federal authority hinges on interstate commerce and commercialization, so manufacturing location matters. Meanwhile faster approval timelines have pulled a growing share of biotech activity toward China and other reforming jurisdictions.
Practical takeaways
6- 1
Understand the debate before forming an opinion 1:00
This is presented as a discussion of trade-offs, not a contest with winners. Approaching regulatory questions with curiosity helps you weigh both speed and safeguards.
- 2
Perception and credibility matter as much as data 14:30
Even strong evidence can fail to earn trust without transparent structures. Look for oversight, accountability, and a track record when evaluating any new health framework.
- 3
Look for institutional safeguards 16:00
Review boards, informed consent, licensed centers, and hospital involvement are the safeguards Montana is building. These structures are what turn access into something more trustworthy.
- 4
Trial results may not describe everyone 23:00
Because trials often exclude people with other conditions, published outcomes may not match how a therapy behaves in the broader population. Keep this context in mind when reading any study.
- 5
Ask questions and seek clarity 24:30
The conversation models asking hard questions about how data is generated and enforced. Curiosity and a request for transparency are always reasonable in health decisions.
- 6
Reform can mean doing less, but better 35:20
Azinger's vision is a leaner gatekeeper focused on doing fewer things well. Whatever your view, the shared goal is a system that is less slow, less costly, and easier for patients.
Topics & chapters
12Longevity Policy: the big question
Kaeberlein introduces the series and asks whether states should regulate experimental medicine, plus his disclosure about serving on a review board.
Meet Nicholas Azinger and Infinita
The guest introduces his mission to fix the speed and cost of generating medical evidence.
Why drug development got slow and costly
The collapsing return on investment in new drugs and Azinger's policy and economics background.
Prospera and the offshore label
Special economic zones, early longevity trials, and why perception is hard to overcome.
Are these real, high-quality trials?
A frank exchange on phase-one trials, data integrity, and skepticism about offshore studies.
Adverse events and enforcement
How any system knows that clinics truly report side effects, in the U.S. and abroad.
Track records and reciprocity
Why Australia's 30-year record earns recognition and how credibility is built over time.
Montana's framework and review boards
How the Experimental Treatment Review Board mirrors an IRB and why hospital adoption matters.
The hidden flaw in clinical trials
Excluding patients with comorbidities and why approved drugs can underperform in reality.
The funding catch-22
Why early biotech struggles to fund phase two and how state access data could help.
Other states and federal law
New Hampshire, stem-cell laws, interstate commerce, and where federal authority applies.
Global competition and biotech federalism
China's speed, the U.S. advantages, and closing thoughts on doing less but better.