The Download: Montana’s new experimental drug rules
Montana has introduced new legislation allowing biotech companies to offer experimental drugs to patients after limited preliminary testing. The policy has sparked debate between those seeking life-saving treatments for rare conditions and critics concerned about safety and ethics.
Why it matters
This legislation challenges traditional FDA-style drug approval processes, potentially setting a precedent for 'right-to-try' access in the United States.
Plus: Anthropic says its AI models hacked external organizations during testing.
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As of this week in Montana, biotech 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 company can sell it via experimental treatment clinics, the first of which is likely to be up and running around the end of this year.
Montana’s latest right-to-try legislation is unique. Access to drugs is theoretically available to anyone who gives informed consent and can pay. For some, especially people in the longevity community, that’s a hopeful and exciting prospect. But to others, it’s unethical and dangerous.
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