Enraging the enemies of medical progress everywhere, the FDA finished up a decade long progress of issuing regulations about how companies can provide information about the off-label use of medical products. Of course the media, including those who do puff pieces on Sid Wolfe, will portray off-label use as inherently dangerous. But to the extent that most off-label uses wind up become standard therapy and to the extent that off-label applications are used a benchmarks in the evaluation of drug safety and efficacy of new drugs in advisory committees, often by the same critics of off-label use to block new drugs, how dangerous is off-label use? And at a time when such use can be monitored, compared and evaluated at a patient level and is often essential because of genetic variation, I want to see who will propose making off-label use illegal. Maybe a study that looks at the number of lives saved and improved through off-label use is in order.
Off Label Gauntlet Tossed Down
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