Case-By-Case Changes To Off-label Promotion
This article was originally published in RPM Report
While FDA has stuck to a narrow interpretation of precedents like the Caronia ruling, arguing that the decision does not in any way change the landscape for off-label promotion, a series of subsequent court decisions used the Second Circuit’s precedent to solidify company’s free speech protections.
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The case against the venous device manufacturer turned on the rights of manufacturers to use truthful off-label speech to promote their products. It joins a growing body of cases in which courts have sanctioned broader off-label speech than has traditionally been allowed by FDA.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.