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
Famous quotes containing the word issue:
“We find it easy to set limits when the issue is safety.... But 99 percent of the time there isn’t imminent danger; most of life takes place on more ambiguous ground, and children are experts at detecting ambivalence.”
—Cathy Rindner Tempelsman (20th century)
“Most people see no reason to stop arguing just because an issue has been decided.”
—Mason Cooley (b. 1927)
“For Banquo’s issue have I filed my mind;
For them the gracious Duncan have I murdered;
Put rancors in the vessel of my peace
Only for them; and mine eternal jewel
Given to the common enemy of man,
To make them kings, the seeds of Banquo kings!”
—William Shakespeare (1564–1616)