And I think I’ll add this every time we have a big drug trial wipe out: keep in mind, that under a safety-only regulatory regime, that people would have been taking this drug (and paying for it, one way or another) for the last few years now, and it would have done them no good at all. When they could have been actually taking something that might help them. We do not know enough about investigational drugs to approve them without efficacy data.
the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
https://blogs.sciencemag.org/pipeline/archives/2019/02/12/th...
for actual drugs, the FDA can and does show up at your plant unannounced with guns for two weeks for an unannounced audit more or less whenever they want.
I await the day they can drop the hammer on the woo-aisle at whole foods with very poorly concealed anticipatory shadenfraude. Right now the best they can do is to sue POM Wonderful and the like : https://www.forbes.com/sites/chloesorvino/2016/05/02/the-ver...
https://www.nytimes.com/2020/01/28/health/purell-fda-ebola-v...
I really hope the FDA tells biogen to take a hike. The last thing people need is false hope, and the last thing we need as a society is to be spending billions of dollars on an alzheimers drug that doesn't work. For something that important (and that profitable), the least biogen could have done is run that trial through the end.