It is the nature of regulators at the FDA to aim for zero risk at any cost, and this is particularly apparent in the case of preventative therapies intended to be deployed widely in comparatively healthy people. Absent unusual political pressure, any number of ongoing deaths while therapies are assessed is treated as an acceptable cost to avoid even small numbers of deaths that may occur due to use of a new therapy. Thus even after aging is recognized as a medical condition by regulators, it is likely that they will make it too expensive to assess potential therapies. Instead, companies will gain clinical approval for treatment of specific age-related conditions, and widespread off-label us…
Regulators Will Likely Continue to Make Development Difficult, Even After Aging is Recognized as a Medical Condition
It is the nature of regulators at the FDA to aim for zero risk at any cost, and this is particularly apparent in the case of preventative therapies intended to be deployed widely in comparatively healthy people. Absent unusual political pressure, any number of ongoing deaths while therapies are assessed is treated as an acceptable cost to avoid even small numbers of deaths that may occur due to use of a new therapy. Thus even after aging is recognized as a medical condition by regulators, it is likely that they will make it too expensive to assess potential therapies. Instead, companies will gain clinical approval for treatment of specific age-related conditions, and widespread off-label us…