By Stewart Gandolf
Chief Executive Officer
It’s entirely possible that you missed the Food and Drug Administration’s (FDA) officiously titled draft guidelines about social media marketing and communications: Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.
Please stick with us for a minute on this one. This topic isn’t just for pharmaceutical and medical device professionals. Everyone who has a chair in the healthcare delivery continuum—from patients to hospitals to physician providers—will want to take a minute or two to review and prospectively comment on this FDA proposal. (Especially those of us who use what the FDA refers to as “emerging electronic media” such as Twitter, Facebook, YouTube and various others.)
You might have missed this because there’s been a two-year gap since the FDA held a public hearing (November, 2009) about how social media and the Internet are used in the promotion of regulated medical products. Then, in that quiet week between Christmas and New Year (December, 2011), the FDA released the 12-page draft and started the 90-day clock for public comment.
“Essentially the draft guidelines specify that pharma and medical device companies must provide only fair, non-promotional information to questions posed over social media,” according to one media summary by the online pub BostInno.
“Each answer should also be shared privately, ‘provided only to the individual making the request directly to the firm,’ according to the draft guidance. Additionally, any persons who are responding to ‘consumer’ questions cannot and should not be a sales or marketing employee, because those roles focus “on promoting a firm’s products.”
Two things you should know…
First, the public—including the industry and healthcare professionals—has until March 26th to submit questions or comments about the draft. The full text and the means to submit comments online can be done via the page on the FDA’s website.
Also, be aware that this is a small, initial and partial slice of the social media pie, and not the long-awaited and comprehensive guidelines. In fact, the emphasis of this document is off-label use and social media is referenced as a useful link of the communications process.
It’s apparent that the FDA intends this as the “first of many planned guidance initiatives,” so stay tuned, hopefully other increments will follow. (Eventually.) Nearly all healthcare providers, hospitals and medical marketing professionals have a stake in how this “big picture” puzzle eventually fits together.
If you’re using social media, you’ll want to follow this conversation, and you may want to comment today…and again as future increments drip into the public domain.