Today, most states have enacted some form of a right-to-try law, and a federal Right to Try Act was enacted in 2018.
The Federal Food, Drug and Cosmetic Act generally prohibits access to investigational drugs that have not yet been approved by the United States Food and Drug Administration (FDA). Patients that have been diagnosed with a life-threatening or seriously debilitating disease may request “expanded access” or compassionate use to gain access to investigational drugs pending FDA’s permission. Right-to-try laws seek to bypass the FDA’s more rigorous requirements for expanded access and permit terminally ill patients to access investigational drugs, biologics and devices that have completed Phase I but have yet to receive FDA approval. Today, most states have enacted some form of a right-to-try law, and a federal Right to Try Act was enacted in 2018. Recently, Montana has sought to further expand access to experimental treatments.
Montana Senate Bill 535
Montana enacted its right-to-try law in 2015, offering terminally ill patients access to experimental therapies that have not received FDA approval. A 2023 bill expanded Montana’s right-to-try law through removal of patient eligibility requirements for access, regardless of medical condition. The 2023 bill, however, did not provide any scheme for the registration and licensing of clinics to administer these treatments. Recently, Senate Bill 535, which passed both houses of the Montana Legislature with bipartisan support and was signed into law on May 12, 2025, expands Montana’s right-to-try law by widening access to experimental and unproven treatments via establishing means for healthcare providers to provide access to and administer experimental treatments to their patients who have given their informed consent.
The new law establishes a framework for the licensure of experimental treatment centers or facilities that specialize in providing experimental treatments to patients. Experimental treatment centers licensed under SB 535 may recommend and ultimately administer an experimental treatment to a patient for compensation. SB 535 also seeks to establish regulatory oversight for experimental treatment centers such as requirements around provider eligibility, safety, reporting and quality assurance.
An “experimental treatment” under SB 535 is a medical intervention involving an investigational drug, biological product, device or other treatment that has successfully completed Phase I of clinical trials but has not yet received full approval from FDA and either remains under investigation for FDA approval or has a demonstrated safety record.
In exchange for the privilege of offering experimental treatments to patients, experimental treatment centers must dedicate 2 percent of their net annual profits toward improving access for Montana residents to experimental treatments.
Experimental treatments directed to assisted suicide appear to be excepted, as the required informed consent must include a statement that the experimental treatment cannot be used to assist in ending the patient’s natural life.
Potential Risks and Fallout
Through the licensure and establishment of experimental treatment centers under the SB 535, Montana is likely to become a destination for medical tourism for those seeking, for example, therapy directed to longevity and other ailments outside of the watchful eye of FDA via unproven experimental treatments. This presents a number of risks for those involved.
Phase I clinical trials, performed using a smaller sample size than Phase II and III clinical trials, are merely directed to assessing the safety of an experimental treatment. There is no assessment whether the experimental treatment itself is effective for a particular indication or whether administration of the experimental treatment is safe over the long term across a much wider patient population. Based on the overwhelming failure rate of clinical trials, the failure of experimental treatments provided under SB 535 is expected, and unlike investigation and review by FDA, there is no regulatory body to safeguard against the distribution and use of an experimental treatment that turns out to be harmful. Thus, experimental treatment centers, manufacturers and providers should expect to defend against allegations of fraud, deceptive marketing and the liabilities that may result from “beta testing” experimental treatments whose effectiveness as to specific medical indications and long-term safety across a wide breadth of patients remain unknown.
Experimental treatments offered in Montana under SB 535 can simultaneously be under FDA review for full approval. Thus, as failure of some experimental treatments is inevitable, such failures may impact FDA’s review of the experimental treatment. This could include, for example, halting clinical trials and enrollment of new patients in view of reported adverse effects from the experimental treatment, such as a patient’s death using an experimental treatment that is under simultaneous FDA review. The failure of the experimental treatment coupled with a delay or possible derailment in FDA review and ultimate approval may lead to unintended devaluation in corporate shares and public image. Thus, entities offering experimental treatments in Montana under SB 535 should anticipate defending against shareholder actions should activist shareholders seek to hold a corporation or its officers accountable for devaluation or other injuries arising from offering experimental treatments under SB 535 that are temporarily, or ultimately, unsuccessful.
Oftentimes, a treatment (drug, biologic or device) is patented prior to receiving FDA approval and commercialization, raising concerns as to possible infringement via use of a patented invention. U.S. patent law under 35 U.S.C. §271(e)(1) provides a safe harbor against patent infringement for the use of a patented invention for activities related to generating and submitting information for regulatory approval of the manufacture, use or sale of drugs or veterinary biological products. Because experimental treatment centers established and licensed under SB 535 can be administering experimental treatments in tandem and parallel with FDA investigation and review, it is not clear whether the safe harbor provision against patent infringement would apply to the experimental treatment center and other associated actors administering an experimental treatment under SB 535.
As there are numerous implications and potential risks associated with the enactment of SB 535, the effects of an expansive right-to-try law circumventing FDA requirements for access to experimental treatments remains to be seen and will be something to be further monitored to ascertain the full scope of its impact.
For More Information
If you have any questions about this Alert, please contact Vicki G. Norton, Ph.D., Brandon A. Chan, Ph.D., any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.
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