Montana's Right to Try Law: What It Actually Changes for Experimental Therapies
Matt Kaeberlein opens his new Longevity Policy series by examining Montana's expanded right to try framework with Stephen Martin, who helped build it. They explain why federal right to try almost never delivers real access, and how Montana changes the incentives with pricing flexibility, no terminal-illness requirement, and dedicated review boards and clinics.
Overview
In the first episode of Longevity Policy, Matt Kaeberlein looks beyond the biology of aging to the rules that decide whether new therapies ever reach patients. He is joined by Stephen Martin, US lead for Infinida, who helped develop Montana's new right to try framework. Kaeberlein first discloses that he serves on one of Montana's experimental treatment review boards (ETRBs).
The conversation explains why the federal right to try system, despite a near-99% approval rate, has treated perhaps only a hundred patients in eight years: companies face 'poor risk-reward' and must provide therapies at cost, losing money on every patient. Montana changes this by letting providers price flexibly, removing the requirement that patients have a life-threatening illness, and creating dedicated review boards and clinics. Martin argues these changes open the door to preventative and longevity-focused therapies while keeping informed consent and patient autonomy at the center.
They discuss the safety and 'snake oil' concerns behind the law's close passage, the four-member structure of an ETRB, and the kinds of post-phase-1 therapies — heavily oncology and neurodegenerative — likely to arrive first. With a $10,000 ETRB fee versus a $1-2 billion approval pipeline, Martin frames Montana as a scalable, structured alternative to the black market. He closes by inviting critics to start their own, more stringent review boards.
Key quotes
5It really boils down to three words: poor risk-reward.
You get zero reward. In fact, you're going to lose money for every single patient that you treat.
I encourage people not to round down in healthcare. Any improvement where more people are incrementally gaining access to care is good.
You need to respect the intelligence of the patient.
If you think we're not doing a good enough job, come put us out of business.
Key ideas
9A legal right that rarely delivers access
On paper, federal right to try and expanded access guarantee access to experimental therapies for serious illness. In practice, patients almost never get treated.
Near-100% approval, near-zero access
About 13 million Americans could theoretically qualify. Yet in a high-volume year the FDA processes ~2,000 expanded access protocols, and federal right to try may have treated no more than a hundred people in eight years.
Two federal pathways
Expanded access requires the company and patient to submit a protocol for FDA permission. Federal right to try only requires the company to notify the FDA — but most companies still decline to use either.
'Poor risk-reward' keeps companies out
Treating patients pre-approval carries regulatory and reputational risk, while at-cost pricing means no financial reward. The system asks for-profit biotechs to take large risks in order to lose money.
Montana's first change: pricing flexibility
Manufacturers, clinics, and review boards can price above cost. Martin says some treatments may even be cheaper than after approval, because there's no billion-dollar pipeline to recoup — and companies still gain valuable data.
No life-threatening requirement
Montana drops the federal rule that a patient must have a life-threatening illness. Martin's example: a cancer-free urologist at high genetic risk of recurrence could access a preventative cancer vaccine that federal law would block.
Dedicated review boards and clinics
Montana creates its own experimental treatment review boards (ETRBs) and clinics, removing the 'doctor shopping' patients faced when hospitals declined pre-approval pathways.
Informed consent as the boundary
Rather than a third party deciding a patient can't choose, Martin argues the patient's informed, non-misleading consent — including honest, probabilistic estimates of risk and benefit — is the core safeguard.
$10,000 versus $1-2 billion
An ETRB application fee is about $10,000, against the $1-2 billion cost of full FDA approval. Any post-phase-1 therapy with good early safety data can be eligible.
Practical takeaways
6- 1
A right on paper isn't access 4:00
Understand that a strong legal right to try doesn't guarantee real access — company incentives, not patient rights, are usually the bottleneck.
- 2
Follow the incentives 14:30
The key structural change in Montana is pricing flexibility; it's what lets companies scale access without going bankrupt on each patient.
- 3
This isn't only for terminal illness 20:00
Montana's framework can cover preventative and quality-of-life therapies, which is why the longevity field is watching it closely.
- 4
Know these are early therapies 24:30
Eligible treatments are post-phase-1 but often pre-phase-2, so efficacy data is limited — informed, realistic expectations matter.
- 5
Ask what's known versus unknown 27:00
For any experimental therapy, informed consent means getting honest, probabilistic estimates of risk and likely benefit before deciding.
- 6
Competition is a built-in check 31:00
Anyone can start a more stringent review board, so patients can choose the standard they trust — a market check on safety.
Topics & chapters
13Revolution or risk?
Kaeberlein introduces Montana's expanded right to try law and the debate over whether it accelerates innovation or lowers standards.
A disclosure and the guest
He discloses his role on a Montana review board and introduces Stephen Martin, who helped build the framework.
What 'right to try' really means
Using the example of a parent seeking an experimental therapy for a child, they define right to try and expanded access.
99% approval, almost no patients
Martin explains how a near-total approval rate still results in only a handful of patients treated federally.
Two federal pathways
The difference between expanded access (FDA permission) and federal right to try (FDA notification).
'Poor risk-reward'
Why regulatory risk, PR risk, and at-cost pricing keep biotechs from offering pre-approval access.
Montana's pricing flexibility
How allowing providers to price above cost changes the incentive to offer experimental therapies.
Billionaires, access, and 'don't round down'
Addressing the 'only for the wealthy' critique and the case for incremental access.
Dropping the life-threatening rule
The prostate-cancer-vaccine example and how Montana opens preventative access.
Dedicated boards and clinics
Montana's ETRBs and clinics, Infinida's role, and the 'IRB light' model for post-phase-1 therapies.
Controversy and patient autonomy
The safety and snake-oil concerns behind a close vote, and Martin's case for respecting patient choice.
Inside the review board
The four required ETRB members and the most-stringent informed-consent standard.
Therapies, costs, and competition
The therapy types arriving first, the $10,000 fee, and an invitation to critics to start their own boards.