FDA Policy: Is Off-Label on the Table?
Wednesday, April 29, 2015
For years the pharmaceutical industry agonized over communicating “non-compliant” off-label claims that, in many instances, were already standards of care. And yet the Food and Drug Administration, always concerned about protecting the free and fair dissemination of scientific information, remained mostly silent. That silence of the regulatory lambs has ended. And the winner is the public health.
To that end, interested readers might have noticed a querulous headline in their March 11 copies of the Washington Post: “FDA proposes to let drug companies undermine official safety warnings.” Unfortunately, it was interesting for the wrong reasons, because the headline was misleading at best and downright wrong at worst. And it wasn't a case of an off-target headline written by an uninterested editor. Here's how the article began: “The Food and Drug Administration is proposing to allow pharmaceutical companies to undermine official safety warnings in sales presentations to customers.”