The Right to Try is Every American's Birth Right
UPDATE
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.
The two recommendations that were adopted significantly improve the Right to Try Law:
Adopted #1
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.
Adopted #2
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."
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.
Proposal #1
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.
Proposal #2
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.
We commend the State of Montana, Senator Ken Bogner, and Governor Greg Gianforte. Read the full Bill↗
Legislative Background
The Perinatal Stem Cell Society and its President, Kyle Cetrulo believes that it will only take three changes to the Right to Try Law to revolutionize access to stem cell therapy and advanced regenerative medicine technologies overnight while maintaining safety and oversight.
On May 22, 2018, President Donald Trump signed the Right to Try Act into federal law enabling terminally ill patients to access drugs that are currently being investigated in FDA approved clinical trials. The Right to Try Bill was an attempt to provide life-saving therapeutic approaches for terminally ill patients. However, the Right to Try Act in its original form has major flaws that severely limits patient access.
Although the Right to Try Bill has been law for 7 years only 16 products have been approved for use and likely only a few hundred patients have benefited. Due to the limitations in the original legislation, new versions of the Right to Try Act are being promoted in Nevada and Montana. However, these new bills also fail to fully address the problems of the original bill and are also too limited in scope.
Perinatal Society Proposed Changes are:
Proposed Change #1
Patient Eligibility Reform
Current Status
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.
Proposed & Adopted (MT)
"Any individual shall be eligible to access an investigational treatment under this Act, regardless of their current health status, medical diagnosis, or condition."
✔ Extends access to any American citizen
The first needed change is to extend access to any American citizen, not just the terminally ill or those who have exhausted other modalities, affirming the right of every citizen to take their health into their own hands by removing eligibility limitations.
Proposed Change #2
Right to Profit & Negotiate
Current Status
Compensation is generally limited to the .
Manufacturers may provide treatments but are not required to do so.
Provides zero incentive for companies to engage with patients.
Proposed & Adopted (MT)
"Allow companies to negotiate directly with the patient and to sell the drug at fair market value with no limit on maximizing profit."
✔ Creates a marketplace for funding & competition
The current Right to Try Law and proposed Bills provide zero incentive for companies to engage with patients and is the main limitation in all three bills. The current reimbursement for the company only covers the cost of goods for the drug. This excludes hard costs and the years of investment in research and development, the cost to operate a laboratory, salaries for the skilled scientists, salaries for the administration and executives, and all of the overall operations that go into actually providing the drug. The cost of goods is a tiny fraction of the actual costs to manufacture the drug.
The goal is to create a marketplace where companies can negotiate and sell the drugs at fair market value and for maximum profit. This small step will revolutionize healthcare in the United States by allowing companies to raise funds for Phase I safety trials and to sell therapeutics profitably during the Phase II and III clinical trial periods.
If the only barrier to get to the marketplace is a Phase I clinical trial there will be 1000s of competing companies entering the market and prices will match the supply and demand of the market driving costs way down and making stem cell therapy affordable.
Proposed Change #3
Sustainable Funding
Company's Clinical Trial:
At the companies discretion, the Right to Try patient can be included in the Phase II and Phase III clinical data set.
Allow companies to fund the cost of the Phase II and Phase III clinical trials through sales of the drug through the Right to Try Law patients. This will enable the company to be profitable during the clinical development stages of the drug development.
This will encourage the company to file additional Phase I Safety trials with their drug and include more indications that patient seeking the Right to Try will be eligible for and have access to.
Proposed Change #4
Remove FDA Fees
Clinical Trial Process Fees:
Remove the $1,000,000 (Million Dollar) Fee imposed by the FDA to launch a Phase I Clinical Trial.
Although not directly related to the Right to Try Law removing the $1,000,000 fee required to launch a clinical trial will drastically lower the cost for companies to conduct the Phase I Safety trial. This will expand the pool of eligible products for patients seeking any therapeutic to improve their health as more companies will be able to raise the funding needed to conduct the Phase I Clinical Trial for their product.