Montana advances framework to sell experimental drugs to consumers

Montana has advanced an initiative to position itself as a hub for experimental medical treatments by expanding its "right to try" framework. Under the state’s new regulatory system, biotechnology companies can apply to a newly established state review board for approval to sell experimental drugs directly to consumers. To qualify, treatments must have completed preliminary safety testing, in some cases involving as few as 10 individuals, alongside a $12,500 application fee.

The policy aims to accelerate access to unapproved therapies for patients facing rare or severe conditions who have limited conventional treatment options. Proponents, including families seeking unapproved therapies for rare genetic diseases, view the framework as a crucial lifeline. However, the system bypasses traditional Food and Drug Administration channels, raising questions regarding patient safety and regulatory oversight for early-stage pharmaceuticals.

Sources: MIT Technology Review.