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FDA Drug Ad Rulings Do Not Need To Rely On Consumer Survey Data – Troy

Executive Summary

FDA decisions on whether direct-to-consumer drug ads are false or misleading do not need to be backed with consumer comprehension data, Chief Counsel Daniel Troy said

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Pfizer prevails in Zoloft suicide lawsuits

A California woman failed to establish a link between warnings on Pfizer's Zoloft (sertraline) and her husband's suicide, a San Francisco federal appeals court rules. "We offer no opinion on the existence of purported side effects associated with Zoloft or on the adequacy of Pfizer's warnings," the 1Feb. 9 opinion states. The court did not address Pfizer's argument that additional warnings would conflict with federal labeling requirements and are preempted. FDA filed an amicus brief supporting Pfizer's preemption argument (2"The Pink Sheet" Sept. 16, 2002, p. 7). Separately, a Denver federal appeals court ruled the parents of a 13-year-old could not prove that Zoloft caused the boy's suicide. Pfizer met with the House Energy & Commerce Committee to provide pediatric safety and efficacy data on Zoloft Feb. 12...

Pfizer prevails in Zoloft suicide lawsuits

A California woman failed to establish a link between warnings on Pfizer's Zoloft (sertraline) and her husband's suicide, a San Francisco federal appeals court rules. "We offer no opinion on the existence of purported side effects associated with Zoloft or on the adequacy of Pfizer's warnings," the 1Feb. 9 opinion states. The court did not address Pfizer's argument that additional warnings would conflict with federal labeling requirements and are preempted. FDA filed an amicus brief supporting Pfizer's preemption argument (2"The Pink Sheet" Sept. 16, 2002, p. 7). Separately, a Denver federal appeals court ruled the parents of a 13-year-old could not prove that Zoloft caused the boy's suicide. Pfizer met with the House Energy & Commerce Committee to provide pediatric safety and efficacy data on Zoloft Feb. 12...

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