DOJ backs Wyeth in preemption case
Pharma Compliance Alert, June 11, 2008
The Department of Justice (DOJ) filed a brief with the Supreme Court supporting Wyeth in an upcoming case on preemption.
The Supreme Court is scheduled to hear Wyeth vs. Levine this fall. At issue in the case is whether patients who have been harmed by a drug can sue under state law if the drug was produced and marketed under terms approved by the FDA.
In the brief, the DOJ argues the FDA weighs the risks and benefits of a drug and considers the overall health consequences of including particular instructions or warnings in a drug’s labeling.
“Because FDA’s approval strikes a balance between competing considerations, state laws that strike a different balance conflict with FDA’s determination and are impliedly preempted,” the DOJ said in the brief.
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