Off-Label Drug Marketing Is 'Free Speech,' Court Rules by John Fauber. Milkaukee Journal Sentinel/MedPage Today. ABC News. December 5, 2012.
The FDA rules governing pharmaceutical company promotion of drugs may have been significantly changed. The broad impact of the decision by the Second Circuit Court of Appeals in New York awaits determination by the U.S. Supreme Court.
Under FDA rules, pharmaceutical companies can only promote a drug for an FDA-approved use. As a result of the Second Circuit decision, the limited focus of pharmaceutical companies' promotion effort has greatly broadened, encompassing promotion of "off-label" uses of the drug. The article addresses the "free-speech" rationale for the decision as well as the public health, and safety implications of the ruling.
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