Off Label at the FDA

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:

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