regulations that are too loose may cause suffering and death while regulations that are too strict will delay or block prevent helpful treatments.
regulating healthcare is extremely difficult and largely a thankless job.
one solution is to approach national healthcare like national security and let people volunteer for treatments like volunteering for the army.
in short, overstate risks but let patients decide.
adopt cigarette-simple consent forms that state in bold words that an experimental treatment is likely to cause death or crippling side-effects like paralysis, blindness, stroke, Alzheimer's, or worse.
perhaps require multiple signatories from family members to guard against irrational behavior.
this protects the FDA while minimizing barriers to innovative therapies and treatments.