Tag Archives: off-label

Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
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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.
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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).
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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?
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Forest Labs Hit with Bad Ad Tattle

Forest Labs has had a tough time with regulators over the last two years. The company’s sales reps can’t seem to stop breaking the law. The latest offense, which generated an Untitled Letter from the Office of Prescription Drug Promotion (OPDP), was brought to light through OPDP’s Bad Ad program, which encourages physicians to report […]
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