The FDA, on the whole, is quite reasonable and well-run. For treatments where there isn't an alternative and the disease is fatal, they do accelerate approvals

The FDA, on the whole, is quite reasonable and well-run. For treatments where there isn't an alternative and the disease is fatal, they do accelerate approvals and they allow more people to use the drug experimentally. For things like Rogaine they are very cautious and even then sometimes make fatal mistakes.