The Experimental State Markets for Experimental Medicine

Access to unapproved treatments has historically been understood through a federal lens. The system was defined by the FDA approval process, with a narrow set of exceptions around compassionate use and, later, Right to Try. That framework was never especially broad, and in practice it remained pretty limited.

States are now starting to build legal and commercial infrastructure around experimental treatments. This makes it easier for physicians to participate, clinics to form, treatments to be marketed, and patients to pay for interventions that still sit outside the traditional approval pathway. 

The Federal Right to Try program has always been narrow. It applies only to certain investigational drugs that have completed Phase I, remain under an active IND, and are sought by eligible patients with life-threatening disease who cannot enroll in a trial. The newer state efforts creating actual delivery channels for experimental care beyond just those for desperate patients to request a one-off treatment. 

Florida may be the clearest example. Its 2025 law authorizes physicians to perform certain non-FDA-approved stem cell therapies in orthopedics, wound care, and pain management, subject to sourcing, consent, and disclosure requirements. The statute clearly contemplates real-world commercialization, and by spring 2026, clinics in Florida were already posting the required disclaimer language online. That is a concrete sign that the law has already changed clinic behavior and accelerated market formation. 

Montana has taken it a step further. Its 2025 law creates licensed experimental treatment centers and broadens the state’s prior Right to Try framework, creating places where experimental treatments can be delivered under a dedicated state framework. Proposed rules would require review boards, public safety summaries, adverse event reporting, and quality systems. Montana is creating the building blocks of an alternative structure.

New Hampshire is worth watching for the same reason. It has already expanded telehealth prescreening and remote signing, and pending bills would move further toward experimental treatment centers and broader stem-cell-specific access. If Florida is the clinic model and Montana is the institutional model, New Hampshire looks like the state most likely to combine the two.

None of this eliminates the federal issue — FDA still has ultitmate authority. A state cannot simply legalize what federal law still treats as an unapproved drug or biologic, and recent stem-cell cases have reinforced that. But that does not make the state laws unimportant. States can change things around the treatment itself: who can offer it, where it can be delivered, how it can be presented to patients, and how payment can happen.

That last point is very important. These markets are unlikely to run through ordinary reimbursement. Medicare generally covers routine trial costs, but not open-ended experimental treatment outside a qualifying research framework. Commercial insurers generally exclude investigational care. So in practice, the likely model here is cash pay, direct contracting, or some other bespoke arrangement. That means these laws are not just broadening access. They are helping create a second commercial track alongside the traditional clinical trial and approval system.

States are beginning to create places where unapproved medicine can be delivered, monitored, marketed, and paid for outside the system that has traditionally governed both access and evidence. Not outside federal law entirely. But increasingly outside the normal institutional pathway that has shaped how experimental medicine reaches patients.