Montana’s plan to become an experimental medical hub just pushed forward
As of this week in Montana, any biotech company with an experimental drug has a clear path to selling it to consumers. Companies whose drugs have been through preliminary testing—sometimes in as few as 10 healthy people—can pay $12,500 to apply to a newly established review board for approval. Once its treatment is rubber-stamped, the…
Montana's recent legislative decision to establish an experimental medical hub has garnered attention and debate. The state's new right-to-try legislation allows biotech companies to sell experimental drugs directly to consumers after a relatively quick and affordable review process. Companies can apply to a newly created review board, comprising a Montana-certified doctor, expert scientists, and an ethicist, for a fee of $12,500.
Once approved, these drugs can be sold via experimental treatment clinics, with the companies setting their prices. This unique approach differs from other jurisdictions that restrict access to such drugs to terminally ill patients. The state's Department of Health and Human Services recently finalized the rules to implement the law, emphasizing rigorous oversight and informed consent from patients.
Critics, however, raise concerns about the potential risks associated with unproven treatments being sold without the oversight of the FDA. Montana's push towards a more accessible experimental treatment landscape is driven by longevity enthusiasts, rather than traditional libertarian or patient groups. The state's journey towards this law began with a 2015 right-to-try law, which was later expanded in 2023 to include all patients, not just those with terminal diseases.
The current version of the law focuses more on preventative medicine, aligning with the vision of state senator Ken Bogner. The expansion was supported by the Alliance for Longevity Initiatives, a nonprofit organization focused on advancing legislation for healthy human lifespan. Longevity enthusiast Niklas Anzinger played a significant role in the process, connecting with Bogner and contributing to the drafting of the law.
Anzinger, based in a special economic zone in Honduras, shifted his focus towards the US, recognizing Montana as a more suitable model due to its existing regulatory precedents. The state's review board, established to evaluate applications for unapproved drugs, includes a Montana-licensed doctor, a bioethicist, and experts in the longevity community.
The board's independence will be maintained, with no affiliation to the organization that funds the board members. As the rules are now in place, Anzinger and his team are working towards setting up the first experimental treatment clinic in the state, with clinics expected to begin operating by the end of the year.
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- The Download: Montana’s new experimental drug rules technologyreview.com