FDA review seeks comment on off-label marketing to doctors—and consumers

The FDA is reviewing the drug maker regulations when it comes to promoting off-label drug uses.

Is the FDA considering allowing pharma companies to tout off-label drug uses in DTC advertising? That’s been the subject of some industry chatter after the FDA began a review of its off-label marketing guidelines at a meeting in November, and then revised and reopened request for comments.

Several media reports, such as those from Consumer Reports and the L.A. Times, indicated that the FDA is considering DTC off-label advertising to consumers. Yet that's not exactly the case. The FDA review focuses on drugmakers’ communication with healthcare professionals; in fact, the docket title begins with the words "Manufacturer Communications."

However, there is one question regarding consumer off-label advertising. It asks: “To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers’ lack of medical training and expertise in critically evaluating this type of information?”


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“We are seeking input on the consumer question, while most of the industry focus has been on communications to health care providers," an FDA spokeswoman said in an interview.

DTC Perspectives' Bob Ehrlich recently wrote a column criticizing articlesl that discuss the possibility of off-label DTC advertising to consumers.

“I know we are in an era of fake news but seriously folks. FDA goes nuts when the background music is too loud on DTC ads. Does anyone think they will allow drug companies to tout off-label uses to consumers? No, they will not," he wrote.

The FDA first held a meeting to discuss off-label communications in November, with online comments staying open until January. But later, the FDA amended its notice to include issues brought up at the November meeting, including First Amendment points raised on both sides. The renewed comment period is now open until April 19. So far, there have been 40 comments posted, most against marketing off-label drug uses or even allowing doctors to write off-label use prescriptions.

While the question doesn’t upend years of FDA rules and guidelines, does the fact that regulators are even asking open the door, even just a crack?

Ehrlich doesn’t think so. “On-label uses are complicated enough in DTC, so adding to that would be unwieldy. I am quite convinced FDA has zero intention to allow off-label use in mass media DTC,” he said in response to follow-up questions. But the way he sees it, "it is possible they may consider it in drug websites where it can be fully explained.”

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