Yes, that’s another irony:
Makers of purified pharmaceuticals are 100% liable for any failure to dream up the perfect scenario of possible misuse, and to make sure that under such misuse (and any accompanying overdosage), the drug remains perfectly safe, or else they get sued for billions.
However, if you never test your product’s safety at all, and you never purify it, it remains a “supplement” and you can make false claims about a deadly product and scarcely ever need to worry about lawsuits.
After testing a new drug in clinical trials among hundreds or thousands of people, and then gaining FDA approval, the drug moves to the full market where millions of people have access to it. Some people think that adding millions of customers for a product as complex as a pharmaceutical should produce the same results as found in the clinical trials. These are also the same people who think all risk can be removed from our lives with enough regulation and oversight. They don't understand much about science or research.
Bringing a NME to market, from discovery to approval, can take more than 12 years and can cost up to $800 million. IIRC, only about 1 in 4,000 drugs proposed in preclinical testing actually ever makes it to market. Anyone who thinks the relationship between industry and the FDA is anything but adversarial has no idea what they're talking about.