FDA offers draft guidance on unsolicited requests for off-label drug information

December 6, 2011

At the end of December, FDA’s Office of Prescription Drug Products (OPDP) issued draft guidance on how pharma companies handle queries via social media. Specifically, the guidelines address how companies should respond to “unsolicited requests for off-label information about prescription drugs and medical devices.”

According to Lori Leskin, a product liability partner at the New York law firm Kaye Scholer LLP, “This is not much of a change from prior, pre-Internet situations, and certainly not the broad-based guidance on social media that everyone in the pharma industry is waiting for—but it does address a small piece of it.”

“Merely acknowledging publicly that there is information available on off-label use could open up a company to liability litigation, so the upshot of this guidance could be simply to keep industry muzzled when it comes to public forums,” Leskin said.

Moreover, Leskin noted, no distinction is made between forums of healthcare practitioners and those of the general public; whether a more open discussion could occur at a physician-only site is an “unanswered question.”


Email Disclaimer