U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted†the law by saying the FDA’s approval of a drug label is only a “first step.†He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.â€
The Solicitor General’s full opinion can be viewed at
http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf
Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case."
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted†the law by saying the FDA’s approval of a drug label is only a “first step.†He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.â€
The Solicitor General’s full opinion can be viewed at
http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf
Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case."
