Issue
If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling? Wyeth presented two arguments in favor of FDA preemption:
- It is impossible for Wyeth to comply with both the state-law duties and federal labeling regulations, see Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, since the latter forbids it from changing its label without FDA approval.
- Permitting states to require stronger warnings creates an unacceptable "obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, because it substitutes a lay jury's decision about drug labeling for the expert judgment that Congress sought to entrust with drug labeling decisions when it created the FDA.
Read more about this topic: Wyeth V. Levine
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