Montana has implemented a program that allows residents to buy experimental drugs that have only completed the first stage of FDA safety testing. The initiative has sparked significant debate over its safety standards and regulatory approach.
The law, known as Senate Bill 455, permits the sale of treatments once they pass Phase 1 of FDA trials. This phase only verifies that a dosage does not cause immediate harm in a small group of participants. The legislation does not require proof of effectiveness or an understanding of possible side-effects. The law has safeguards that may or may not prevent unethical conduct.
Supporters of the program include technology entrepreneurs who advocate for faster access to potential longevity treatments. They position the law as a market-driven experiment, whereas opponents argue it could encourage companies to bypass federal oversight by confining operations and advertising within Montana’s borders.
Because these drugs will likely remain outside insurance and Medicare coverage, the primary consumers are expected to be affluent individuals willing to pay out of pocket. However, it’s possible some less affluent people will use up their savings to get them.
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It’s possible that firms can evade FDA jurisdiction by avoiding any connection with interstate commerce. The federal agency retains control over advertising and cross-state transportation of unapproved drugs, potentially triggering enforcement actions if violations occur.
If anything does go wrong in an individual case, there will surely be some interesting product liability claims. Others have mentioned the possibility of lawsuits against firms by other states’ governments if their own citizens become guinea pigs. Montana’s regulatory agencies face challenges in monitoring a rapidly expanding private market, particularly given their limited resources and the profit-driven incentives of participating businesses.
The absence of randomized controls and small sample sizes will likely weaken the reliability of any findings. But if the (statistically meaningless) results look promising, it might help a start-up get enough funding to undertake serious drug testing within the FDA process.
The FDA generally does feel strongly about interstate advertising and transportation of unlicensed drugs and medical devices. The FDA retains the power to intervene against cross-state promotion of unapproved products, and enforcement could be triggered if evidence of interstate commerce emerges.
