Thursday, October 30, 2008

FDA Staff Objected to Preemption

The House Oversight and Government Reform Committee released a report and supporting documents yesterday showing that career FDA staff objected to FDA drug labelling requirements preempting state consumer lawsuits against drug manufacturers.  (See my related post, Backdoor Preemption, here.)  The WSJ reports here; LA Times reports here.

The release comes just before the Supreme Court hears oral arguments in Wyeth v. Levine on Monday.  SCOTUSWiki collects the briefs--including an impressive array of amicus briefs--here.  (Thank you.)

The Committee posts its report and collects the documents here.  These documents illustrate the behind-the-scenes legal, political, and bureaucratic back-and-forth over preemption and other issues, offering a fascinating case study in how we get a claim of preemption via regulation in a case like this.  I recommend especially the report's Executive Summary, the Supporting Documents for Section A, and the Supporting Documents for Section E.

SDS

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