The Consequences of Caronia: Impact On FDA’s Off-Label Regulation
This article was originally published in RPM Report
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?
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Guidance on scientific exchange is on the horizon; agency “carefully evaluating” existing advertising policies following recent court decisions.
Off-label promotion prosecutions are supposed to be much tougher in the post-Caronia period. However, it is not too hard for the government to make a compelling case when a marketing manager calls one off-label use the “golden goose” for a product line.
If Amarin can’t get its Vascepa expanded indication through FDA, it could try to get the courts to clarify the scope of free speech protections post-Caronia.