Publications

FDA Withdraws Proposed Rule Abolishing Generic Preemption; Recognizes “Downsides” Of Expanded Tort Liability

December 17, 2018

On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected (CBE) procedure to add new safety information to their labeling—something that name-brand manufacturers have long been able to do. The proposed rule would have abolished so-called Mensing preemption for generic drug manufacturers, exposing them to tort liability on the same terms as name-brand manufacturers.

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