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Legal Minute: Off-label marketing not ok again?
Manage episode 403641886 series 3506216
Contenuto fornito da Darshan Kulkarni. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Darshan Kulkarni o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First Circuit ruled against Facteau, emphasizing the distinction from the Caronia case. Unlike Coronia, where the focus was on broader free speech and off-label promotion issues, the US v. Facteau case centered on the roles and actions of individuals involved. Notably, Facteau's direct executive involvement in promoting off-label uses, coupled with evidence of intent to circumvent FDA regulations, set this case apart. This ruling highlights the nuanced considerations surrounding off-label marketing and underscores the importance of individual actions and intent in legal outcomes.
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