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FDA pre-emption update



As we noted on Mar. 21, the much ballyhooed FDA statement on pre-emption in the preamble of its warnings regulations had no more force of law than the amicus briefs it had been filing for several years, and thus could continue to be disregarded by judges indifferent to the public policy implications. Attorney Stephanie A. Scharf, writing for Law.com, notes that that is precisely what has happened in several cases, as courts disagree on whether to apply the FDA position. The matter could go to the Supreme Court, as the differing positions percolate up the appellate ladder. The first appellate court to rule, the Second Circuit, decided against applying the FDA standards in Desiano v. Warner-Lambert et al.

 

 


Rafael Mangual
Project Manager,
Legal Policy
rmangual@manhattan-institute.org

Katherine Lazarski
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.