Beyond Terminal: How Montana Is Redefining Right to Try Laws

For patients facing serious illness, the search for hope often begins with approved treatments. When those fail, clinical trials may offer a lifeline, but what happens when no trial exists? For decades, patients and families have asked this question, and lawmakers have responded with pathways designed to expand access to experimental therapies. Two of the most significant are the Expanded Access Program and Right to Try laws. Recently, Montana has pushed this frontier even further, creating a new model that could reshape patient options nationwide.

Expanded Access: The Original Pathway

The U.S. Food and Drug Administration (FDA) introduced the Expanded Access program, often called “compassionate use,” in 1987. Its purpose is to allow patients with serious or life-threatening conditions to access investigational treatments outside of clinical trials. However, the process is complex, requiring coordination between the patient’s physician, the drug manufacturer, and the FDA. Approval depends on whether the potential benefit outweighs the risk and whether the request will disrupt ongoing studies. 

While Expanded Access offers hope, it can be slow. For patients in critical condition, time is a luxury they may not have.

Right to Try: A Faster Alternative

Right to Try laws emerged as a way to bypass the FDA’s approval process for individual cases. These laws allow terminally ill patients to access experimental treatments that have passed Phase I safety trials without FDA involvement. Colorado led the way in 2014, and by 2018, the federal Right to Try Act was enacted. Today, 41 states have similar laws, giving patients more control over their treatment options.

The Evolution: Right to Try 2.0

Medicine does not stand still, and neither does the law. In recent years, several states have introduced what is referred to as “Right to Try 2.0.” These updates expand eligibility beyond terminal illness to include patients with debilitating conditions who have considered all approved treatments. They also address individualized therapies, such as genetic treatments tailored to a single patient, making them especially relevant for rare diseases and personalized medicine.

Montana Pushes the Frontier

Montana has taken the boldest step yet. In 2023, the state passed Senate Bill 422, removing the requirement that patients be terminally ill. Under this law, any patient can access experimental treatments that have completed Phase I trials, provided they give informed consent. It is important to note that Phase I trials are designed primarily to assess safety, not efficacy, and most investigational drugs do not progress to later approval stages.

Then, in 2025, Montana enacted Senate Bill 535, creating a licensing framework for clinics offering experimental treatments. The law also requires licensed centers to allocate 2% of their annual net profit to provide free experimental care for qualified Montana residents or contribute to a new insurance premium support fund. Together, these bills make Montana the first state to open experimental treatment access to all patients, not just those at the end of life.

How Does Montana Compare?

To understand the impact, consider the differences:

• Traditional Right to Try laws: limit access to terminally ill patients and require no FDA oversight.

• FDA Expanded Access: involves a formal approval process and physician oversight.

• Montana’s approach: removes the terminal illness requirement, mandates clinic licensing, and introduces financial support for patients.

This shift raises important questions: Will patients benefit meaningfully from unapproved treatments? Could Montana become a destination for medical tourism? And will other states follow suit?

Criticisms and Ethical Concerns

While Montana’s new laws expand access to experimental treatments, they have also drawn criticism from medical and bioethics communities. Experts warn that allowing access to drugs after only Phase I trials—designed to assess safety, not efficacy—may expose patients to unproven therapies with unknown benefits. The lack of FDA or Institutional Review Board oversight, combined with broad legal immunity for providers, raises concerns about patient safety and accountability. Critics also point to the potential for Montana to become a destination for medical tourism, attracting patients from other states or countries seeking experimental therapies, which could lead to commercialization and inequities in access. Advocates for the laws argue that they empower patient autonomy and accelerate medical innovation, but the debate over appropriate safeguards and ethical standards continues. For patients considering experimental treatments, understanding the risks, benefits, and limitations—and ensuring truly informed consent—is essential.

Frequently Asked Questions

1. What is the Right to Try law?

   It allows patients to access experimental treatments without FDA approval if the drug has passed Phase I safety trials.

2. How does Right to Try differ from Expanded Access?

   Expanded Access requires FDA approval and oversight; Right to Try bypasses the FDA for eligible patients.

3. What does it mean if a drug has completed Phase I trials?

   Phase I trials are the first stage of human testing and are designed to evaluate safety, not whether the drug is effective. Most drugs do not advance beyond this stage to become approved treatments.

4. Which states have Right to Try laws?

   Currently, 41 states have Right to Try laws, along with a federal law enacted in 2018.

5. What is Right to Try 2.0?

   An updated version that includes patients with debilitating conditions and supports individualized therapies.

6. Does Montana allow non-terminal patients to access experimental treatments?

   Yes. Montana’s SB 422 and SB 535 make experimental treatments available to any patient who provides informed consent.

The Future of Patient Access

Montana’s recent moves could signal a new era in patient autonomy. As these laws are implemented, it will be important to monitor their real-world impact—tracking how clinics comply with new requirements, how patients are affected, and whether other states adopt similar measures or introduce new legislative changes. For patients considering experimental treatments, the importance of informed consent and thorough patient education cannot be overstated, especially given the risks and uncertainties associated with therapies that have not completed full clinical testing. Ongoing evaluation of outcomes in Montana and elsewhere will be essential for future updates and for ensuring that expanded access is both safe and effective. One thing is clear: the conversation about access to experimental treatments is far from over.

Authored by Lisa Krist, Berkley Life Sciences, VP, Chief Customer Focus Officer