Montana’s SB535 allows Phase I experimental drugs to be prescribed and sold, bypassing standard FDA timelines

@ATabarrok @SebastianCaliri Great article Alex! I am trying to organize care for this patient, a three year old boy, under SB535. We are almost there, just need the FDA to promise the manufacturer they won’t be punished for treating using a state law.

We are meeting with them on the 18th. 🤞

Montana’s SB535, signed into law in May 2025, is the most important regulatory innovation in drug approval in my lifetime. The law lets drugs be prescribed and sold in experimental treatment centers once they have passed Phase I trials. A very big deal. https://marginalrevolution.com/marginalrevolution/2026/06/montanas-sb535-and-a-potential-biotech-renaissance-in-america.html

The law cannot do that unless the FDA chooses to look the other way -- federal law is supreme and FDA regulation of drugs preempts state law. FDA may effectively look the other way -- but in that case, the law was not actually necessary, and still doesn't create a solid legal framework for clinician/provider/investigator certainty unless and until FDA creates a formal policy for accommodating it.

@ATabarrok Issue is who will pay. Certainly not insurers.

@ATabarrok Didn't Arizona pass something like this in the past?

@ATabarrok @paulg This could totally change the game!

@ATabarrok Perfectly articulated! Wire services picking this up.

@ATabarrok Completely validates this. Significant news.

@ATabarrok Unbelievable! Digital platforms amplifying reach.

@ATabarrok can't see the actual post content here. is the feed broken or just me?

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