In what way does the Montana law make snake oil salesmanship hard? Why can't a bad actor just repeatedly file INDs, go through Phase 1 (soon will be close to trivial given AI-enabled drug discovery/design), then sell to unsuspecting consumers as a panacea, then rinse and repeat?
They're absolutely trivial compared to Phases 2 and 3, and part of the cost/complexity of Phase 1 is self-incurred because it's to the company's advantage to detect problems as early as possible. Remove that incentive (because they don't plan to pursue Phase 2, 3, or clearance), and it becomes much cheaper and easier to run broken Phase 1s.
The FDA does not let you put something in humans without a significant amount of data, full stop. And even for a small trial, the cost of the GLP tox and the GMP manufacturing is in the millions.
Of course it is nowhere near as complex as phase 2. But it is not remotely trivial.
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Of course it is nowhere near as complex as phase 2. But it is not remotely trivial.
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I’m saying that the millions of dollars in expenses are irrelevant if you can recoup those costs plus some profit by selling snake oil.
Your comment is just “millions of dollars is a lot of money!” I don’t care whether you think that’s a lot of money.
If you think that cost cannot be recouped by selling snake oil for some reason, then explain why.
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