Montana Changes Right to Try Law to Include Perinatal 1st and 2nd Changes
Montana’s newly enacted Senate Bill 535 (SB 535), signed into law by Governor Greg Gianforte in May 2025, significantly expands the state's "Right to Try" legislation and includes the Perinatal Society’s top two recommended changes to the Bill. This is a huge step forward to bringing stem cell therapy to everyone in the United States.
This law permits healthcare providers to offer experimental treatments that have completed only Phase I clinical trials, bypassing the traditional FDA approval process.
Expanded Eligibility
The patient no longer needs to be terminally ill but rather anyone who has exhausted other avenues can utilize this law and try any drug that has completed a Phase I clinical trial.
Direct Negotiation
Companies can now negotiate directly with the client and sell the drug for a profit. This creates immediate market incentives after proving safety in Phase I.
"In my opinion, this will revolutionize the stem cell field because now after completing a Phase I Clinical trial to prove the safety of the drug, a company now has a market to make a profit from the sale of the drug."
Future Goals & Context
The Perinatal Society recommends two more changes to be adopted in other states. Currently, 12 additional states are considering similar Right to Try Law improvements.
Phase II & III Data Inclusion
Patients who access the drug via Right to Try should be included in official Phase II and Phase III clinical trial data sets. This would enable companies to fund the rest of the clinical trial with Right to Try Patient financing.
Remove $1M FDA Fee
Removing the $1,000,000 fee to file a Phase I Clinical Trial with the FDA would allow more companies to enter the market. Competition for indications like knee injections would lower costs dynamically.
Legislative Background
On May 22, 2018, President Donald Trump signed the Right to Try Act into federal law. While an attempt to provide life-saving approaches, the Perinatal Stem Cell Society and its President, Kyle Cetrulo, believe the original form had major flaws that limited patient access.
Below are the specific detailed proposed changes championed by the Society to revolutionize access.
Patient Eligibility Reform
- Patient must have a or "life-threatening" condition.
- Strictly limited to conditions defined in various state bills (S. 204, SB 422).
- Considered all FDA-approved treatments exhausted.
"Any individual shall be eligible to access an investigational treatment under this Act, regardless of their current health status, medical diagnosis, or condition."
Right to Profit & Negotiate
- Manufacturers may provide treatments but are not required to do so.
- Compensation is generally limited to the .
- Provides zero incentive for companies to engage with patients.
"Allow companies to negotiate directly with the patient and to sell the drug at fair market value with no limit on maximizing profit."
Additional Required Modifications
Company's Clinical Trial Data
Allow companies to fund the cost of later clinical trials through sales of the drug via Right to Try. This expands the pool of eligible products for patients seeking therapy.
Clinical Trial Process Fees
This hurdle prevents many companies from conducting Phase I trials. Removing it creates massive competition for valuable indications like knee injections or heart disease stem cell treatments, driving down costs.