I know people say the law is confusing but most experts I've talked to and my reading of the law - says companies can't make profit off RTT...https://twitter.com/GideonGil/status/1009539155167236098 …
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Replying to @SarahKarlin
how are they defining "profit" though? like, a single dollar over the cost of manufacturing? or can companies factor in development costs?
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Replying to @damiangarde @SarahKarlin
The problem is - I am told, I’m not a lawyer - is, if a company says, well $150,000 is our cost, we r not making a profit, there’s no entity charged with confirming that. Under expanded access, the confirmation of cost would be done by the FDA. So, who will keep companies honest?
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There's no entity charged w confirming the price is only direct costs beforehand. But I think FDA can check that after the fact. The law functions as an exemption to usual FDA reqs. If parameters of law-including for charging-aren't met, FDA reqs apply.
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Perhaps, but that remains to be seen. Also, given Sen. Johnson's slapdown of @SGottliebFDA fired having the temerity to suggest that the @US_FDA should have a rule in #RightToTry, who thinks he's going to be enthusiastic about investigating such things? I don't.
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