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FDA Off-Label Citations Disappear In Post-Caronia Enforcement Letters

 
• By Sarah Karlin-Smith

Office of Prescription Drug Promotion letters post-Caronia fail to cite off-label promotion, in contrast to previous years when about one-third to one-half of warning and untitled letters scolded companies for off-label violations.

FDA’s Office of Prescription Drug Promotion did not cite off-label promotion in enforcement letters sent to drugmakers in the four months following the Dec. 3, 2012, U.S. v. Caronia appellate court decision, a stark contrast to past years when about one-third to one-half of warning and untitled letters would contain such a violation.

But industry attorneys suggest it may too soon to say the landmark case impacted FDA’s approach to issuing letters and believe the agency still has “work-arounds” that could let it...

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