Montana's rules governing state-licensed clinics that sell treatments the Food and Drug Administration has not approved took effect at the end of July, and the first review boards are now organizing to begin clearing therapies for sale.
The framework makes Montana the first state to license commercial facilities to recommend and administer experimental drugs, biologics, and devices to paying patients, under a law signed last year. The only federal milestone a treatment must clear is Phase I of clinical testing, the stage designed to check basic safety in a small number of people. It is not designed to show that anything works.
