Life sciences practice partner Kellie Combs (Washington, D.C.) was quoted in a December 2016 Medical Marketing & Media article discussing the sharing of off-label information with health care payers.
Ms. Combs, who testified at the U. S. Food and Drug Administration (FDA) hearing in November on behalf of the Medical Information Working Group, explains that payers play a gate-keeping role with respect to patients and that drug manufacturers are interested in getting information to payers as soon as possible to facilitate patient care. Because prescribing decisions are increasingly made by health systems and formulary committees exert so much influence over which treatments patients may receive, allowing drugmakers to communicate with payers about data outside a product's label is critical.
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