Tag Archives: Preemption

Liability Looms for Generic Drug Safety Labeling Changes

FDA is proposing to revise its rules to permit generic drug manufacturers to initiate safety labeling changes, and not wait until the brand company takes that action. The aim of the new policy is to inform consumers more quickly of emerging safety concerns – but it also could create confusion by allowing prescribing information to […]
Posted in FDA, Legal, Regulatory, Safety | Also tagged , , , , , , | 1 Comment

Preemption Watch: You've Been Warned

The Supreme Court on Wednesday issued its decision in the much-watched case of Wyeth v. Levine—which many in pharma hoped would firmly establish FDA decisions as a bulwark against common-law liability suits in state courts. The decision, as you’ve no doubt heard already, went against Wyeth. Pharm Exec‘s coverage is here. The opinion is here. […]
Posted in Legal | Also tagged , , | 6 Comments

Wyeth v. Levine: Inside the Preemption Case

Last week, the Supreme Court heard arguments in the long-awaited preemption case, Wyeth v. Levine. For the first time, the highest court in the land is weighing in on whether federal approval of a drug preempts tort claims against a drugmaker, such as an injured consumer might bring in a state court. A decision for […]
Posted in Legal, Regulatory | Also tagged , , , , , | Leave a comment
  • Categories

  • Meta