Harvard professors demand science-based pharmaceutical marketing

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Two Harvard professors have objected to a court ruling concerning Amarin Corp's fish oil drug Vascepa.

Pharmaceutical manufacturers are not permitted by the US Food and Drug Administration to market their products for non-FDA (off-label) indications.

“Two Harvard professors have objected to a court ruling concerning Amarin Corp's fish oil drug Vascepa.“

However, Amarin sought permission to do so for Vascepa on the grounds that those statements were "truthful and non-misleading".

Furthermore, it argued that the First Amendment's protection of commercial speech meant it was entitled to make these statements - a point of view later supported by a federal court.

Harvard professors Spencer Phillips Hey and Aaron Kesselheim responded by saying the "truthful and non-misleading" statement is a tautology, as it is only truthful because of its logical construction - not because it reflects the latest scientific evidence. 

"Since the off-label marketing statement is actually misleading when viewed from this perspective, the federal court’s conclusion was incorrect," they said.

"We propose that informativeness in asserting scientific facts, rather than truthfulness, ought to be the gold standard for evaluating commercial speech about pharmaceuticals."

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