Accordingly, the Mensing analysis is not affected by FDAAA because the Generic Manufacturers are still unable to unilaterally change drug labeling without special permission and assistance, which is dependent on the exercise of judgment by a federal agency.
is aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce. Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.
found that generic manufacturers have a federal duty of "sameness" to, at all times, insure that the label for the generic drug is identical to the label adorning the corresponding reference-listed drug.
Hence, the "duty of sameness" also applies in the context of generic drug design. Mensing stands for the principle that a federal duty of sameness arising out of FDA's regulatory requirements preempts any conflicting tort duty arising under state law.