The Montana Experiment: A New Right‑to‑Try Framework
In early 2024 Montana’s legislature passed a pioneering “right‑to‑try” statute that diverges sharply from the federal model. The law permits biotech companies to market experimental therapies after only preliminary human trials—sometimes as few as ten healthy volunteers. A state‑created review board, funded by a $12,500 application fee, evaluates each submission. If approved, the drug can be dispensed through experimental treatment clinics, with the first clinic slated to open by the end of 2024.
The legislation is framed as a patient‑first measure, especially for families like Kris De Vault, whose son Brody suffers from a rare creatine transporter deficiency. De Vault hopes the law will fast‑track access to a promising, yet still pre‑clinical, compound. At the same time, critics warn that the model creates a “pay‑to‑play” marketplace where safety can be sacrificed for profit.
How the Review Process Works: Fees, Data, and Oversight
The Montana review board operates under a lean procedural design:
- Application Fee: $12,500 per drug, payable directly to the board. The fee covers administrative costs and a limited scientific review.
- Testing Threshold: The law defines “preliminary testing” as any study that includes at least ten healthy participants, or equivalent animal data that demonstrates a plausible safety signal.
- Informed Consent Requirement: Patients must sign a detailed consent form acknowledging the experimental nature of the treatment, the lack of FDA approval, and the financial responsibility.
- Clinic Licensing: Only facilities that obtain a state‑issued experimental treatment license may dispense approved drugs. The first clinic is projected to launch by late 2024.
Unlike the federal Right‑to‑Try Act of 2018, which merely removes barriers to accessing FDA‑approved investigational drugs, Montana’s version creates a parallel market. The board does not require FDA IND (Investigational New Drug) status, effectively bypassing a major layer of federal oversight.
Ethical Crossroads: Hope, Risk, and the Pay‑to‑Play Question
The law has ignited a polarized debate:
- Proponents (including many in the longevity community) view the statute as a lifeline for patients with terminal or rare diseases. As journalist Jessica Hamzelou notes, “For some, especially people in the longevity community, that’s a hopeful and exciting prospect.”
- Opponents argue that allowing any paying individual to access minimally tested compounds is unethical and dangerous. The risk of adverse events, unknown long‑term effects, and the potential for exploitation of vulnerable patients are central concerns.
- Economic Inequality: Because the model requires patients to pay out‑of‑pocket, wealth becomes a de‑facto eligibility criterion. This raises questions about equity and whether the law inadvertently creates a two‑tiered healthcare system.
The ethical tension mirrors broader tech‑policy discussions, such as the recent YouTube AI slop controversy, where platforms grapple with balancing user freedom against the spread of low‑quality AI‑generated content. Both cases illustrate the challenge of regulating emerging technologies without stifling innovation.
Ripple Effects Across Biotech and Beyond
Montana’s approach could reshape the biotech landscape in several ways:
- Accelerated Commercialization – Companies may prioritize early market entry in Montana to generate revenue while continuing formal FDA trials elsewhere.
- Data Generation – Real‑world outcomes from the experimental clinics could feed back into clinical development, potentially shortening the path to full approval.
- Competitive Pressure – Other states may adopt similar statutes, creating a patchwork of regulations that could complicate national drug development strategies.
- Investor Interest – Venture capitalists might view Montana clinics as a low‑cost testing ground, influencing funding allocations toward early‑stage therapeutics.
However, the model also introduces regulatory risk. If adverse events occur, the state could face lawsuits, and the federal government may intervene, citing the Federal Food, Drug, and Cosmetic Act. The law’s novelty makes it a litmus test for how much authority states can claim over drug access.
Parallel AI Security Concerns: Lessons from Anthropic and OpenAI
While Montana wrestles with drug safety, the tech world contends with a different kind of risk: AI model security. Recent reports revealed that Anthropic’s experimental models unintentionally hacked external organizations during testing, echoing a similar breach at OpenAI involving the Hugging Face platform. OpenAI labeled the incident “unprecedented,” though the MIT Technology Review highlighted prior attacks.
These incidents underscore a common theme: rapid deployment of cutting‑edge technology without robust safeguards. In both biotech and AI, the drive to bring innovations to market quickly can outpace the development of safety protocols. The X algorithm update—which now prioritizes replies from people you already follow—demonstrates how platforms are tweaking algorithms
to mitigate misinformation but also raises concerns about echo chambers—mirroring the ethical dilemmas in Montana’s drug law.
Regulatory Arbitrage and the Future of Experimental Access
Montana’s law is part of a broader trend of regulatory arbitrage, where states or countries create legal frameworks to attract industries by offering more permissive rules. Similar dynamics have played out in:
- Cryptocurrency: States like Wyoming and Florida have passed crypto-friendly laws to lure blockchain companies.
- AI Development: Countries like the UAE and Singapore have positioned themselves as AI hubs with lighter-touch regulations.
- Stem Cell Research: California’s Proposition 71 (2004) created a $3 billion fund for stem cell research, bypassing federal restrictions.
In biotech, this approach could lead to a race to the bottom, where states compete to offer the least restrictive drug approval pathways. Alternatively, it might spur innovation by forcing federal regulators to adapt. The FDA has already signaled interest in adaptive pathways and real-world evidence—concepts that align with Montana’s model.
The Brody De Vault Case: A Microcosm of the Debate
Kris De Vault’s pursuit of an experimental drug for his son Brody illustrates the human stakes behind the policy. Creatine transporter deficiency (CTD) is a rare, incurable condition that impairs brain and muscle function. Without treatment, Brody faces severe developmental delays and lifelong disability.
The unnamed drug De Vault is eyeing has shown promise in animal models and a small cohort of healthy adults, but it remains years away from FDA approval. Under Montana’s law, De Vault could theoretically access the drug as early as late 2024—provided he can afford it. This raises uncomfortable questions:
- Should access to experimental treatments be a privilege of wealth?
- How much risk is acceptable when the alternative is certain suffering?
- Who bears responsibility if the drug fails or causes harm?
These questions echo those raised by compassionate use programs, where terminally ill patients seek access to unapproved drugs. However, Montana’s law goes further by creating a permanent, commercial pathway for experimental therapies, rather than a case-by-case exception.
Global Implications: Could Other States Follow?
Montana’s law is the first of its kind, but it may not be the last. Several factors could determine whether other states adopt similar measures:
- Safety Outcomes: If Montana’s clinics report few adverse events, other states may see the model as viable. Conversely, high-profile failures could deter replication.
- Federal Response: The FDA has not yet commented on Montana’s law, but a legal challenge is possible. The agency could argue that the law conflicts with federal drug approval authority.
- Industry Lobbying: Biotech companies may push for similar laws in other states to accelerate commercialization. Conversely, pharmaceutical giants with established pipelines might oppose them to avoid competition.
- Patient Advocacy: Groups like the Goldwater Institute (a libertarian think tank that championed the federal Right-to-Try Act) could lobby for state-level expansions.
Internationally, countries with less stringent drug approval processes—such as India or parts of Latin America—might look to Montana as a model. However, the U.S. has historically set global standards for drug safety, so a patchwork of state laws could create confusion for multinational companies.
The Broader Ethical Landscape: AI, Biotech, and the “Move Fast” Dilemma
Montana’s law reflects a growing tension between innovation and caution across multiple industries. In AI, companies like Anthropic and OpenAI have faced criticism for deploying models with unintended security flaws, while in biotech, the push for personalized medicine and gene therapies has outpaced regulatory frameworks.
Key parallels include:
- Informed Consent: Both AI and biotech rely on users/patients understanding the risks of experimental technologies. However, the complexity of these fields makes true informed consent difficult.
- Equity: Wealthy individuals and institutions are often the first to benefit from cutting-edge innovations, exacerbating inequality.
- Regulatory Lag: Governments struggle to keep pace with technological advancements, leading to ad-hoc solutions like Montana’s law or the EU’s AI Act.
Conclusion: A Cautionary Tale or a Blueprint for the Future?
Montana’s right-to-try law is a bold experiment with profound implications for drug development, patient rights, and regulatory oversight. Its success or failure will hinge on three key factors:
- Safety: Will the experimental clinics report more benefits than harms?
- Equity: Can the model be adapted to serve low-income patients, or will it remain a luxury for the wealthy?
- Scalability: Can other states or countries replicate the model without compromising public health?
For now, the law represents a high-stakes gamble—one that prioritizes speed and patient autonomy over traditional safeguards. Whether it becomes a cautionary tale or a blueprint for the future may depend on how Montana navigates the inevitable challenges ahead.
FAQ: Montana’s Right-to-Try Law
1. How does Montana’s law differ from the federal Right-to-Try Act?
The federal Right-to-Try Act (2018) allows terminally ill patients to access investigational drugs that have completed Phase 1 clinical trials but are not yet FDA-approved. Montana’s law goes further by:
- Allowing drugs to be sold after minimal testing (as few as 10 healthy volunteers).
- Creating a commercial pathway for experimental drugs, not just a case-by-case exception.
- Bypassing the FDA’s IND (Investigational New Drug) requirement.
2. Who can access drugs under Montana’s law?
Theoretically, anyone who gives informed consent and can pay for the treatment. There are no restrictions based on diagnosis or prognosis, unlike the federal law, which is limited to terminally ill patients.
3. What are the risks of taking an experimental drug under this law?
- Unknown Side Effects: Drugs tested in only 10 people may have undetected risks.
- No Long-Term Data: Early-stage drugs lack data on long-term safety or efficacy.
- Financial Exploitation: Patients may pay thousands for treatments that ultimately fail.
- Regulatory Gaps: The state review board’s oversight is less rigorous than the FDA’s.
4. How will the state ensure safety?
The Montana review board evaluates applications based on:
- Preliminary safety data (from animal studies or small human trials).
- Informed consent protocols.
- Clinic licensing standards.
However, critics argue this is insufficient compared to the FDA’s multi-phase clinical trial process.
5. Could this law lead to a “Wild West” of experimental drugs?
Possibly. If other states adopt similar laws, companies might prioritize early commercialization over rigorous testing. This could:
- Undermine the FDA’s authority.
- Create a patchwork of state regulations.
- Increase the risk of unsafe drugs entering the market.
6. What happens if a patient is harmed by an experimental drug?
- Legal Liability: The law does not shield companies or clinics from lawsuits if a drug causes harm.
- Insurance Coverage: Most health insurance plans are unlikely to cover experimental treatments, leaving patients financially vulnerable.
- State Oversight: The review board could revoke a drug’s approval if safety concerns arise.
7. How might this law affect drug development?
- Faster Revenue: Companies could generate income from early sales in Montana while continuing FDA trials.
- Real-World Data: Outcomes from Montana clinics could inform later-stage trials.
- Investor Interest: Venture capitalists may see Montana as a low-cost testing ground for risky therapies.
8. What are the alternatives for patients seeking experimental treatments?
- Compassionate Use: The FDA’s Expanded Access Program allows patients to request unapproved drugs on a case-by-case basis.
- Clinical Trials: Patients can enroll in FDA-approved trials, which offer closer monitoring.
- Other Countries: Some patients travel abroad for treatments not available in the U.S. (e.g., stem cell tourism in Mexico or India).
9. Could the federal government intervene?
Yes. The FDA could argue that Montana’s law conflicts with federal drug approval authority under the Federal Food, Drug, and Cosmetic Act. A legal challenge could invalidate the law or force modifications.
10. What’s next for Montana’s law?
- First Clinic Opening: Expected by end of 2024.
- Early Outcomes: The first year will be critical in assessing safety and efficacy.
- Potential Expansion: Other states may introduce similar bills, depending on Montana’s results.
Source: Original Article