As he looks ahead to further battles over drug pricing, approvals and opioid abuse, newly confirmed FDA Commissioner Dr. Robert Califf will also be forced to grapple with another challenge: the legal and practical pitfalls of off-label marketing regulation. Lawsuits last year highlighted the inadequacy of the current “intended purposes” standard for drug makers and healthcare providers at a time when the number of off-label prescriptions has soared, and in response the FDA promised new standards guidelines for “truthful and non-misleading” off-label promotion that have yet to be released. In the meantime, some in the policy community–including scholars at Dr. Califf’s alma mater, Duke University–have introduced several concepts, including a tiered labeling system based on the strength of clinical evidence for off-label applications, integration with FDA’s “Sentinel” surveillance system, and third-party review.

The Duke white paper is available here:
http://structurecms-staging-psyclone.netdna-ssl.com/client_assets/dwonk/media/attachments/56c6/61b7/6970/2d57/02bf/0000/56c661b769702d5702bf0000.pdf?1455841719

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