Montana Advances Experimental Drug Sales Via New Review Board

As of this week, Montana has established a clear pathway for biotech companies to sell experimental drugs directly to consumers. Companies that have completed preliminary testing, which can involve as few as 10 healthy individuals, can now apply to a newly formed review board for approval by paying a $12,500 fee. Once a treatment receives this approval, the company gains the authority to set its price and market it through experimental treatment clinics, with the first such clinic anticipated to open by the end of the current year. This legislation, referred to as Montana's latest right-to-try law, distinguishes itself from similar laws in other jurisdictions. Unlike laws that restrict access to drugs solely for individuals with terminal illnesses, Montana's law theoretically permits access to anyone who provides informed consent and can afford the treatment. This broadens eligibility to include individuals seeking treatments for rare diseases, as well as those interested in longevity and preventative therapies. The state's Department of Health and Human Services recently finalized the rules necessary for the law's implementation. These regulations mandate that patients must give fully informed consent, and each drug application must undergo review by a specialized board. This board is composed of a Montana-certified doctor, expert scientists, and an ethicist. Proponents of the law emphasize their commitment to a responsible approval process. Matt Kaeberlein, a scientist serving on the initial board, which was formed independently of the state health department, stated that the process "will be done in a very rigorous way, with qualified medical professionals and appropriate oversight." However, concerns have been raised by other experts regarding the potential risks associated with selling unproven treatments to the public without the oversight of the U.S. Food and Drug Administration (FDA). Aaron Kesselheim, a professor of medicine at Harvard Medical School specializing in health policy and drug regulation, expressed his apprehension, stating, "I would be concerned." There has been a discernible increase in efforts across the United States to enhance the accessibility of unapproved drugs. Montana's legislative approach, however, is considered unique in its design and implementation, reportedly driven and drafted by individuals focused on longevity research and access to experimental therapies.