The inaugural U.S. center for innovative medical therapies is on the horizon.

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The idea that individuals have a right to access experimental treatments has, in fact, faced setbacks in US courts, according to Carl Coleman, a bioethicist and legal scholar at Seton Hall in New Jersey. He refers to a case from two decades ago: In the early 2000s, Frank Burroughs founded an organization aimed at improving access to developmental drugs. His daughter, Abigail Burroughs, had been diagnosed with head and neck cancer and struggled to access experimental treatments. In 2003, about two years after Abigail’s passing, the organization sued the FDA, arguing that people with terminal cancer should have a constitutionally protected right to access experimental, unapproved treatments once those treatments have completed phase I trials. However, in 2007, a court rejected that argument, ruling that terminally ill individuals do not have a constitutional right to experimental drugs.

Bateman-House also raises concerns about a provision in a Montana bill that aims to enhance treatment equity. It states that “experimental treatment centers” should allocate 2% of their net annual profits “to support access to experimental treatments and healthcare for qualifying Montana residents.” Bateman-House notes that such language is uncommon in legislation. While it may seem beneficial, it could potentially introduce additional risks to the local community. “On one hand, I appreciate equity,” she remarks. “On the other hand, I don’t support equity for ineffective treatments.”

After all, the doctors prescribing these drugs cannot guarantee their effectiveness. It is unethical to require payment for treatments when their efficacy is unknown, Bateman-House adds. “That’s how the US system has been structured: There’s no profit without evidence of safety and efficacy.”

The clinics are on the way. Any clinics offering experimental treatments in Montana will only be permitted to distribute drugs manufactured within the state, according to Coleman. “Federal law mandates that any drug intended for interstate commerce must have FDA approval,” he explains. White expresses little concern about this. Montana already hosts manufacturing facilities for biotech and pharmaceutical firms. “That was one of the specific advantages of focusing on Montana, as everything can be conducted in-state,” he notes. He also believes that the current administration may be inclined to modify federal laws regarding interstate drug manufacturing.

At any rate, clinics are indeed planning to establish themselves in Montana, according to Livingston. “We have several interested parties, and perhaps two or three that are definitively going to set up shop.” While he won’t disclose names, he mentions that some clinicians already operate clinics in the US, while others are based internationally.

Mac Davis—founder and CEO of Minicircle, the company that developed a controversial “anti-aging” gene therapy—stated he was “looking into it.” “I believe this could be an opportunity for America and Montana to effectively dominate the market in medical tourism,” Livingston adds. “There is no other place in the world with this unique regulatory environment.”

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