Montana lawmakers expanded right-to-try access beyond terminal illness, allowing patients with any condition to seek Phase 1 experimental therapies through state-licensed centers — and the state last month approved its first treatment, for hearing loss. The clinical catch: the FDA has not assured participants it will stand down, leaving clinicians, patients, and companies exposed to federal enforcement risk.

The Move

• Last year, Montana passed Senate Bill 535, creating a state pathway for patients with any condition to access experimental therapies that have cleared Phase 1 testing.

• Unlike the federal Right to Try Act, Montana’s law allows companies to charge for treatment, provided a private review board approves it, the patient gives informed consent, and a provider recommends it.

• The first approval under the law came last month for a hearing-loss treatment.

Why It Matters For Care

• For clinicians, this creates a new route for patients seeking options outside standard care — not just for life-threatening illness, but for any condition.

• At the bedside, providers may face more requests to recommend investigational products with limited evidence beyond Phase 1 safety data.

• That raises practical questions around informed consent, documentation, liability, cost exposure, and how to counsel patients when efficacy remains unproven.

Between The Lines

• The push is driven by critics of the FDA approval model who argue trial costs suppress competition, delay access, and keep prices high.

• Backers also designed incentives the federal pathway lacks: companies can be paid, potentially making participation more attractive than under the national right-to-try framework.

• Critics, including ethicists and some Montana legislators, see a commercialization risk: a market for unproven interventions with lighter oversight and strong industry interest.

What To Watch

• Whether the FDA signals enforcement discretion — or takes action against centers, manufacturers, or clinicians involved in Montana cases.

• Whether more treatments win approval in Montana and whether other states copy the model.

• Whether poor outcomes, adverse events, or political scrutiny trigger court fights, federal-state conflict, or legislative revisions.

Source: Reason