Tag Archives: Appeals Court

Lanham Act: Peer-Review on Trial

Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage? The dividing line between fact and fiction becomes increasingly blurry in the age of prolific […]
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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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