Most Montanans probably have no idea that our state has positioned itself to become one of the most unusual experimental medicine markets in the country.
This is not something being proposed for someday.
It is already law.
In 2023, Montana expanded its Right to Try law through Senate Bill 422. The change removed the requirement that a person be terminally ill before seeking certain experimental treatments.
Then Montana went significantly further.
In 2025, the Legislature passed Senate Bill 535, sponsored by Republican Sen. Ken Bogner of Miles City. Gov. Greg Gianforte signed it into law.
SB 535 created a new category of medical facility in Montana called an Experimental Treatment Center.
These centers may provide certain drugs, biological products, devices and other medical treatments that have successfully completed Phase I clinical testing but have not been approved by the Food and Drug Administration for general use.
That deserves to be understood clearly.
Phase I is early human testing.
Completing Phase I does not mean a treatment has been proven effective. It does not mean all of its risks are known. It means it has crossed an early threshold in clinical development.
Yet under Montana law, a person does not have to be dying to receive one of these treatments.
The patient must evaluate available FDA-approved options, receive a recommendation from a treating health care provider, give informed consent and receive documentation that the requirements have been met.
There is no terminal illness requirement.
These Treatments Can Be Sold
This is also not simply a compassionate program where a drug company gives an experimental medication to a dying patient for free.
Montana law expressly allows manufacturers, health care providers and health care facilities to establish payment arrangements with patients for experimental treatments.
Experimental Treatment Centers may enter into payment arrangements with patients, providers and third-party payers.
The law even specifically allows arrangements involving digital and alternative currencies.
Insurance companies and government programs are generally not required to pay for these experimental treatments.
That means Montana could be creating something substantially different from the traditional idea of Right to Try.
It could become a cash-pay experimental medicine market.
Montana Wants Companies to Come Here
That possibility is not speculation pulled from thin air.
Supporters of SB 535 openly discussed attracting biotechnology companies and patients to Montana.
During legislative testimony, Dylan Livingston, founder of the Alliance for Longevity Initiatives, described Montana’s earlier Right to Try expansion as one of the best frameworks in the country for longevity and preventive medicine.
While supporting SB 535, Livingston went further.
He told Montana lawmakers the law could create an economic opportunity and said Montana could become the nation’s premier hub for medical tourism.
Some Montana lawmakers immediately questioned whether becoming a medical-tourism destination was something the state should be pursuing.
That question deserves far more public discussion than it has received.
Montana Is Licensing the Centers
This is not completely unregulated medicine.
Experimental Treatment Centers must be licensed through the Montana Department of Public Health and Human Services.
The initial state licensing fee established by the law is $10,000, with a $5,000 annual renewal fee.
The law also requires informed consent and authorizes additional state rules surrounding the operation of the centers.
Montana has been developing rules involving medical oversight, treatment review, patient records, adverse events and other safeguards.
There is also a requirement that an Experimental Treatment Center allocate 2 percent of its annual net profits toward health care access for qualifying Montana residents. That can be accomplished through free experimental treatment or a contribution to a state insurance premium support account.
But there is an important phrase there:
Net profits.
Two percent of net profit is very different from 2 percent of revenue.
That provision should eventually be examined closely to determine how much money actually reaches Montana residents once these businesses begin operating.
This Does Not Mean the FDA Disappeared
There has been some breathless reporting suggesting Montana companies can simply go around the FDA.
That is too simplistic.
Montana can change Montana law.
It cannot erase federal law.
Federal authority still exists over drugs and biologics, interstate commerce, manufacturing, clinical trials, labeling and numerous other areas.
Even organizations involved in developing Montana’s experimental-treatment system acknowledge that approval through a Montana treatment-review process does not magically create federal FDA approval.
Exactly where Montana’s authority ends and federal authority begins could become one of the biggest legal questions surrounding this entire experiment.
There Is Another Question Montanans Need to Start Asking
So far, most of the conversation has centered on medical freedom, patient choice and attracting biotechnology investment.
Those are legitimate issues.
But they are not the only issues.
What happens if this becomes an industry?
Biotechnology and pharmaceutical companies do not exist only inside examination rooms.
Depending upon what eventually comes here, the industry can involve laboratories, manufacturing facilities, chemical storage, pharmaceutical compounds, biological materials, specialized waste, wastewater, electricity, water, transportation and industrial infrastructure.
There is no evidence at this point that SB 535 itself authorizes companies to pollute Montana or exempts pharmaceutical manufacturers from environmental laws.
It does not.
But if Montana’s stated goal is to attract an entire new medical and biotechnology industry, then environmental questions need to be asked before the industry arrives, not after something goes wrong.
Pharmaceutical manufacturing has created serious environmental problems elsewhere.
Federal environmental agencies have documented pharmaceutical compounds entering wastewater streams, and research has found dramatically elevated pharmaceutical concentrations downstream from some wastewater treatment plants receiving discharges from pharmaceutical manufacturers.
That should matter in a state where groundwater, rivers, fisheries, agriculture and clean water are not simply environmental talking points.
They are part of Montana’s economy and way of life.
And Where Are All These People Going to Live?
There is another part of this discussion that Helena cannot pretend does not exist.
Montana is already struggling with housing.
We already have communities where local wages cannot keep pace with home prices.
We have families competing for limited housing and land against people arriving with incomes and purchasing power earned in much wealthier markets.
We have watched houses, ranches and land that once passed from one Montana generation to the next become increasingly difficult for the next generation to afford.
Now our state is openly discussing attracting wealthy biotechnology companies, investors, executives, scientists, medical professionals and medical tourists.
They will need housing.
They will need water.
They will need roads, utilities, health care, emergency services and wastewater capacity.
A Silicon Valley executive earning several hundred thousand dollars can compete for a Montana house in a way a teacher, firefighter, ranch worker, mechanic or young Montana family often cannot.
That is not an attack on people moving here.
It is basic economics.
When large amounts of outside money enter a limited housing market, prices move.
Before state leaders celebrate another outside industry coming to Montana, they should be able to answer a simple question:
Can Montana absorb it without pricing Montanans out of Montana?
There May Be Benefits
There absolutely may be.
A successful biotechnology industry could bring high-paying jobs, scientific research, medical innovation and treatments that help people who have exhausted conventional options.
Some experimental treatments available today may ultimately become tomorrow’s standard medicine.
Patients should also have meaningful rights in deciding what happens to their own bodies.
Those arguments deserve to be heard.
But medical freedom does not require blind faith in pharmaceutical companies.
Economic development does not require blind faith in Silicon Valley investors.
And supporting innovation does not mean Montana should volunteer its people, water, land and communities without asking hard questions first.
Montana has already changed the law.
Companies are interested.
Advocates are openly talking about medical tourism and building a longevity industry here.
So before the laboratories, treatment centers and investment dollars arrive, Montanans deserve to know exactly what we signed up for.
Not just what might be gained.
What might be lost.
And who gets the benefit if this experiment succeeds.
Because there is a very important difference between creating wealth for Montana and simply creating wealth in Montana.
Sources
Montana Code Annotated 50-12-102 establishes the current definition of experimental treatment, including the Phase I requirement and lack of general FDA approval.
Montana Code Annotated 50-12-104 establishes current patient requirements and contains no terminal-illness requirement.
Montana Code Annotated 50-12-103 expressly permits payment arrangements for experimental treatment.
Montana Code Annotated 50-12-106 addresses insurance and permits Experimental Treatment Centers to establish payment arrangements, including digital and alternative currencies.
The enrolled version of SB 535 created the Experimental Treatment Center licensing structure and authorized DPHHS rulemaking.
Montana Code Annotated 50-5-251 establishes the 2-percent-of-net-annual-profits health freedom and access requirement.
Legislative reporting from the House debate documents Dylan Livingston’s testimony describing Montana as a possible national hub for medical tourism and records lawmakers’ concerns about that prospect.
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