June 2009
Can Failure-to-Warn Claims Against Generic Drug Manufacturers Be Preempted?Courts Are Divided
By Sharon Caffrey, Alan Klein and Paul M. da Costa
The tension between the salutary purposes of the Hatch-Waxman Act (low-cost drugs widely and quickly available to patients) and the necessity to change label warnings when science or adverse event reports show a newly appreciated risk, presents a Hobson’s choice to generic drug companies, complicated by the FDA’s own interpretation of its CBE regulations as inapplicable to them.
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