University of Southern California

Runaway Preemption: The Reckless Doctrine of Pliva and Mutual Pharmaceutical

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Note by Michael E. Bowlus
From Volume 88, Number 4 (May, 2015)

88 S. Cal. L. Rev. 913

In March 2014, Gordon Johnston issued an urgent warning to members of Congress: the Food and Drug Administration was “[d]isregarding decades of regulatory stability” by proposing a new regulation that “raises patient safety concerns and threatens the system that created thousands of affordable options for consumers.” Johnston, himself a former deputy director at the FDA, was joined at a press briefing by economist Alex Brill, who estimated that the proposed regulation, if approved, would raise annual U.S. health care costs by $4 billion.

Just what, exactly, was the FDA proposing to do? In the Agency’s words, it sought to “clarify procedures” allowing drug manufacturers “to change . . . product labeling to reflect certain types of newly acquired information.” In plain English, the ultimate consequence of the rule would be explicitly to permit generic drug manufacturers to update their labels with new safety warnings on a temporary basis, pending subsequent agency approval. Under current regulations, brand-name drug manufacturers are already able to update their warning labels in a similar fashion. However, the Agency has taken different positions over the years regarding whether generic drug manufacturers may update their labels. The proposed rule, announced in November 2013, would eliminate the ambiguity by establishing parity between both types of drug manufacturers with respect to label updates.

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