FDA dishes out long-awaited guidance on social media

With drug and device makers seeking rules of the social media road from regulators, the FDA quietly issued draft guidance to shed light on its thinking about a specific area of concern for pharma marketers—responding to certain requests for info on off-label uses of products. The agency's guidance doesn't give drug and device companies a road map for traversing social media platforms such as Facebook and Twitter, but it is progress nevertheless in what has been a slow process for giving the industry a clue about how to proceed without getting into trouble with regulators.

The guidance outlines what the agency considers an unsolicited request for information on an off-label use of an FDA-approved product, and it provides some clarity as to how companies should respond to such requests. It leaves a lot of gray area that is open to interpretation, assuring that there will continue to be head-scratching scenarios that companies will face when interacting with the public via a variety of online and social media venues.

Still, the guidance does help companies grappling with how to respond to, say, a patient's query about misinformation on a product that they gleaned from a third-party website. The guidelines leave plenty of room for the FDA to fill in some of the gray areas on social media with future guidelines, and additional guidance is in the offing, an FDA spokeswoman told Ad Age. With consumers flocking to YouTube, Facebook and Twitter, drug companies have been upping their spending on online promotions but doing so without the kind of rulebooks they use for TV and print advertising.

"What everybody was looking for was never going to happen. If you're waiting for divine guidance, you're still waiting," Peter Pitts, president of the Center for Medicine in the Public Interest, told Ad Age. "I doubt there is ever going to be definitive rules for social media-marketing like there are for TV and print. And there's a reason for that. FDA has made it very clear they were not going to make platform-specific guidelines, like how to use Facebook, how to use Twitter, because social media evolves every day."

- here's the FDA's guidance (.pdf)
- read the Ad Age article

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.