Montana’s Medical Experimentation Law: A New Frontier—or a Dangerous Gamble?
- The Rare360 Editorial Team
- 4 hours ago
- 3 min read
In a move that's sparked both intrigue and alarm across the medical and bioethics communities, Montana has taken a radical leap forward in the controversial world of "Right to Try" legislation. With the passage of State Bill 535, the state now allows the licensing of “experimental treatment centers”—facilities where patients can access medical products that have cleared only Phase I clinical trials but lack full FDA approval. Even more striking: anyone can receive these unapproved therapies, regardless of their medical condition.
A Bold Break from Tradition
Montana’s new law goes far beyond existing federal and state Right to Try statutes. Traditionally, these laws are limited to patients with serious or life-limiting illnesses, offering them a last-ditch opportunity to access potentially life-saving treatments not yet approved by the FDA. By contrast, SB 535 removes virtually all guardrails, allowing broad public access to early-stage experimental treatments.
For supporters—many of whom belong to the growing longevity movement—this represents a long-awaited breakthrough. These advocates include scientists, libertarians, and influencers united by a belief that medical innovation is being throttled by excessive regulation. To them, the law is a much-needed correction, opening the door to accelerated human advancement, including longer, healthier lifespans.
Ethical Red Flags and Oversight Gaps
But critics aren’t so enthusiastic. Organizations like the Consortium for Universal Patient Access (CUPA) have consistently opposed Right to Try laws, citing the lack of crucial safeguards. In Montana’s case, there is no FDA or Institutional Review Board (IRB) oversight, which are normally required under the FDA’s expanded access (compassionate use) program.
Alison Bateman-House, co-chair of CUPA and a prominent voice in bioethics, was blunt when asked about the law. “I hate it,” she told MIT Technology Review, pointing to the risks of patient harm when therapies are made widely available without sufficient vetting.
The potential for exploitation is real. As Vice Magazine put it, Montana’s new law enables clinics to “sling new, barely tested therapies, and rake in the cash.” With few restrictions and high demand from desperate or curious patients, the door may be wide open for commercial abuse.
Ohio’s Legislative Echo
Montana isn’t the only state flirting with the boundaries of regulated care. Ohio’s House Bill 12, introduced in January, aims to enshrine the right to off-label prescribing—allowing any approved drug to be used for any condition, so long as the patient consents. While off-label use is already legal, this bill would strip away some of the current checks designed to ensure such prescribing is appropriate and evidence-based.
The bill’s language and intent raise questions about whether it’s a clarification of rights or a veiled loosening of oversight. Like Montana’s law, it may empower providers but at the cost of patient protection.
The Bigger Picture: Medical Freedom vs. Medical Safety
At the heart of both bills is a fundamental tension: the desire for medical freedom versus the need for medical safety. Proponents argue that innovation and personal autonomy are being strangled by a cautious bureaucracy. Opponents warn that without rigorous oversight, patients could become guinea pigs for treatments that are unsafe, ineffective, or exploitative.
Montana’s legislation may serve as a testing ground for how far states are willing to go to bypass federal systems. It may also provoke a reckoning—legal, ethical, and medical—about how we balance innovation with responsibility in the age of personalized, experimental care.
As the ripple effects of SB 535 unfold and Ohio’s bill works its way through the legislature, all eyes are on the states to see whether this is the dawn of a new medical frontier—or the erosion of evidence-based care.