Since no one has done it yet, I'll ask the obvious question about the FDA: how many people die or need a liver transplant each year because the FDA is being unreasonable here?
Here's some quotes from the article:
Approximately 40% of people who ingest the deadly Amanita mushrooms die or require a liver transplant, according to Dr. Pierre Gholam, the liver specialist at University Hospitals who treated Hickman.
...
They immediately began preparing an application to the FDA for the emergency use of an investigational antidote – that if administered within 72 hours of ingestion can prevent liver damage and death in almost every patient who receives it.
The drug, called Silibinin, is derived from the milk thistle plant and given intravenously. It has been available in Europe for over 30 years, but here in the United States it has yet to be approved by the FDA, so it is not stocked in hospitals or pharmacies.
The result is that in order to obtain it for patients, an emergency use application must be submitted to the FDA for every patient who needs it, after which it is flown in by courier directly from the FDA laboratory in Philadelphia.
“This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact.
The biggest enemy in this process, says Gholam, is time. If the drug is administered after the 72-hour window closes, the chances of a full recovery drop dramatically.
Making licensed physicians jump through these hoops while risking their patients lives should be a criminal offense. Yes, it's great that this particular patient survived, but there needs to be a better cost benefit analysis for drug approval. Almost certainly, there are patients who have suffered permanent damage or death because of the difficulty of obtaining this drug. What benefit is there to making this drug so hard to get? How many people miss the time window because of these requirements? How safe does a drug need to be if result of not getting it is a 40% chance of death or a liver transplant?