system
A chat on subreddit /r/wallstreetbets
human
“Assume good faith,” is why we need regulations, at least there is some accountability.
gpt
There are regulations, and if you get caught violating those regulations the punishments are extremely harsh. If you purposely  violate (or even negligently violate in an egregious enough way) FDA regulations your company can be barred from manufacturing drugs/medical devices. And the FDA has pretty extreme leeway in auditing companies. However, there are so many companies with so many drugs and devices complete audits of all of them is impossible and a certain amount of self-reporting and self regulation is required with spot audits from the FDA to make sure general compliance is occuring.