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Legal Minute: Off-label marketing not ok again?
Manage episode 403641886 series 3506216
Inhalt bereitgestellt von Darshan Kulkarni. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Darshan Kulkarni oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.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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