Tag Archives: US v. Caronia

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
Posted in Advertising, Agency Insight, E-Media, FDA, leadership, Legal, Marketing, Regulatory, social media | Also tagged , , , , , , | 1 Comment

Temple 'Horrified' by Caronia Decision

If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).
Posted in compliance, FDA, Marketing, Sales | Also tagged , , , , | 2 Comments

US v. Caronia: What Constitutes 'Truthful' Speech?

If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?
Posted in Advertising, compliance, FDA, Legal, Marketing, Regulatory, Safety, Sales, Strategy | Also tagged , , , , , , , , , , , , , , , , , | 1 Comment
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