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Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Fazal Khan

This article proposes a novel framework for more broadly securing the benefits of “off-label” drug usage while mitigating the harms inherent to this practice. Once the FDA approves a drug, doctors can prescribe for it any indication they think is reasonable, even uses that have not been thoroughly tested. The FDA bans the marketing or promotion for off-label uses by drug companies precisely because such uses have not been validated to be safe or effective through the regulatory process. Further, there are serious concerns with validity of industry-sponsored off-label research related to practices such as ghostwriting, gag-clauses on researchers, and …