For many years the FDA refused to approve defibrotide while children and adults died in the US. Had GENT failed to prove effectiveness in treating VOD and MOF? In a formal sense yes, (and the FDA is all about dotting "i's") but the drug had been used successfully for decades in Italy and the EU. Eventually, the FDA approved it. But too late for many that died.
Snake oil turned proven drug? ;-)
The T in the road we face is that the approval process in the US is very expensive and if it is to be maintained, we need to stick with getting ripped off on price.
If we constrain pricing of drugs, we will necessarily constrain drug development.
You can't have your cake and eat it too.
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