. Federal law provides a process for removing an unsafe drug from the market and grants the FDA discretion to make a final decision as to the safety of a medication—not federal judges.
“The judge doesn’t have the authority to withdraw approval for a drug. Congress has a very specific procedure in the Food, Drug and Cosmetic Act for withdrawing drug approvals,” Cohenlast month. “He may order the FDA to follow the withdrawal process, but that withdrawal process leaves the final decision in the FDA’s hands. So if there’s any wiggle room in the judge’s order, they could interpret the ruling as a requirement to start this process. And then they start that process.
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