Montana Law Allows Phase I Drugs to Bypass Traditional FDA Approval
6 reported
A new Montana law, SB535, signed in May 2025, authorizes investigational drugs that have cleared Phase I trials to be prescribed and sold without following the traditional FDA approval pathway, according to a report from Marginal Revolution. The law makes Montana the first state to license experimental treatment centers described as “one stop shops” for hard-to-access care. The report states this positions Montana as a highly attractive location for biopharma and life sciences companies seeking to accelerate time-to-market while continuing the federal FDA approval process. The article notes that experimental treatments under this law are cash-based, not covered by Medicaid, Medicare, or private insurance. The report also mentions a separate Florida law, CS/CS/SB 1768, that allows physicians to market and administer non-FDA approved stem cell therapies for orthopedic conditions, wound care, and pain management. The article describes these state-level experiments as “regulatory federalism” and suggests the Trump administration has been supportive of such frameworks.
What’s reported
Montana’s SB535 was signed into law in May 2025.
The law authorizes investigational drugs and therapies that have cleared Phase I trials to be prescribed and sold, bypassing the traditional FDA approval pathway.
Montana is the first state to license experimental treatment centers.
Experimental treatments under SB535 are cash-based and not covered by Medicaid, Medicare, or private insurance.
Florida’s CS/CS/SB 1768 allows physicians to market and administer non-FDA approved stem cell therapies for orthopedic conditions, wound care, and pain management.
The article states the Trump administration has been supportive of state right-to-try frameworks.
Sources: marginalrevolution.com
