Consistency is important. I can't say most of the time that FDA is way too strict and is causing lives by delaying approvals, and then disagree when it approved

Consistency is important. I can't say most of the time that FDA is way too strict and is causing lives by delaying approvals, and then disagree when it approved a likely useless drug - even if the drug is likely useless. I'm going with the grey option and say that FDA should approve drugs primarily based on harm, with a note on usefulness. It then should be the decision of other regulatory bodies, or even better doctors whether the harm is worth the benefit for each individual case. And definitely there should be a separate decision on whether it's covered by Medicare - makes absolutely no sense to spend good money on a shady drug just because it got FDA stamp.