Wednesday, November 3, 2010

Solicitor General files brief on preemption debate regarding generic drugs

Here is the perfect follow up to my most recent post! As I reported back in June (here), the U.S. Supreme Court has asked the U.S. Department of Justice to "express the view of the United States" on whether the FDCA preempts failure to warn claims against generic drug manufacturers. This morning, the FDA law blog is reporting that the U.S. Solicitor General of the United States has filed its highly anticipated amicus brief. The Solicitor General’s recommendation is that the Supreme Court deny review given the current lack of a split of authority among the Circuit Courts on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.” For the quick background to understand this story go here. Go here to read the story in the FDA law blog. Go here for a copy of the brief itself. For my previous posts on this topic go here, here, here, here, here, here and here. Here is the bottom line of the Solicitor General's brief: "The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted, because a generic pharmaceutical manufacturer, like a brand-name manufacturer, can (and indeed, must) inform FDA of new information about risks that may require a change in the labeling of its drug." UPDATES: 9:45am: More on the story at SCOTUS blog here. 10:15am: Pharmalot has the story here. Nov 4: Drug & Device law blog has a comment here. Nov. 5: has a comment here.

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