Because no drug is completely risk-free, and because different people have different tolerances for risk, there’s absolutely no scientifically objective way for the FDA to determine if a new drug is objectively too risky or not. That question is one of personal preferences and not one of science. And that question isn’t miraculously transformed into a scientific question by government charging teams of scientists to assess whether this or that drug is “too risky.”
The pretense of science is not science. If government officials truly wish to be scientifically driven, they would allow each of us adults to choose which drugs we wish to take, regardless of the objective likelihood that someone will die or be seriously injured if he or she chooses to be treated with some drug.
Put differently, the scientifically correct level of riskiness of drugs for me is whatever level of riskiness I choose to tolerate. I — not some third party, not even one with an M.D. and who is appointed by government — am the only person on Earth capable of knowing the truth about what is, for me, the appropriate level of riskiness of drugs. Ditto for you.