The Consequences of Caronia: Impact On FDA’s Off-Label Regulation
• By Kate Rawson
The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?
The Food & Drug Administration has made two public statements about the off-label promotion case United States v.Caronia since the Second Circuit Court of Appeals handed down its landmark (and controversial) decision
on December 3.
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