Tuesday, January 25, 2022 10:26:23 AM
M- IMO the Generics are bullet proof here. Any bioequiveloncy claim they make is based on FDA's (inadequate, IMO) rules, which they (Generics) have complied with.
Generics keep gaming the system, successfully. They play within rules that the system has set. As much as it pains me to say, the Generics aren't our enemy; the system is.
The same system that allows them to sell via "skinny label".
The same system that allowed Du to overrule the USPTO.
The same system that tells consumers that a bright-yellow, rotten-smelling, untested capsule is the same as a crystal-clear, odor-free, 7-year-tested capsule.
Note that the product could meet FDA standards but still violate consumer fraud laws, if the generic manufacturer omits material facts about the product from consumers, where knowledge of those facts would affect the consumer's decision to use the product.
Generics keep gaming the system, successfully. They play within rules that the system has set. As much as it pains me to say, the Generics aren't our enemy; the system is.
The same system that allows them to sell via "skinny label".
The same system that allowed Du to overrule the USPTO.
The same system that tells consumers that a bright-yellow, rotten-smelling, untested capsule is the same as a crystal-clear, odor-free, 7-year-tested capsule.
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