FDA Labeling Rule Creates Liability Risk For Generics Cos.
By Erin Coe (November 8, 2013, 10:20 PM EST) -- A new U.S. Food and Drug Administration proposal to let generic-drug manufacturers independently update product labeling when they discover new safety data could open them up to failure-to-warn suits and dilute the effectiveness of their warnings by spurring overdisclosure, lawyers told Law360 Friday.
The rule proposed Friday would remove existing restrictions preventing generic-drug companies from changing safety information until the brand-name counterpart has received agency approval for similar revisions. Generics companies would now be allowed to submit a so-called "changes being effected" supplement, which the FDA would review and have the option of rejecting later, according to the agency.
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