Montana expanded right-to-try rules let biotech companies sell unproven experimental drugs directly to paying consumers
Montana's new right-to-try rules took effect July 25. Companies whose drugs have cleared preliminary testing, in as few as 10 healthy people, can pay $12,500 for review board approval, then sell the drug at any price they choose. No terminal illness required, per MIT Technology R
Montana has finalized rules that let biotech companies sell experimental drugs directly to consumers, effective since July 25, according to MIT Technology Review. Companies whose drugs have been through preliminary testing, in some cases as few as 10 healthy people, can pay $12,500 to apply to a newly formed review board. Once approved, the company sets its own price and sells through experimental treatment clinics, with the first expected to open by year's end. Unlike right-to-try laws in other states, which limit access to the terminally ill, Montana's law is open to anyone who gives informed consent and can pay, including people seeking unproven longevity treatments. The law was driven largely by longevity entrepreneur Niklas Anzinger and state senator Ken Bogner rather than the patient advocacy groups typically behind such legislation. Two applications, for drugs treating neuropathy and hearing loss, have already been submitted. Harvard Medical School's Aaron Kesselheim has raised concerns about the lack of FDA oversight, noting that in phase III trials, around 17 percent of drugs are found to be inadequately safe. Unlike the FDA's expanded-access program, which limits companies to charging only for costs, Montana places no cap on price.