A regulatory landmine: FDA and social media

October 24, 2011 – 5:45 AM | By Mark McCarty | No comments yet

One little misstep is all it takes

Anyone who reads this blog on a regular basis knows I’m leery of big government, and I usually criticize government (most often FDA) for what it does rather than what it fails to do. It appears to be time to give FDA the once-over once again, this time over the agency’s omissions regarding social media.

As readers of Medical Device Daily know, the Center for Devices and Radiological Health has proposed using social media for compliance and enforcement activities, which I covered in the Oct. 7 edition. I should point out that the agency already uses social media as a part of its day-to-day media outreach, but telling your followers on Twitter you’ve just approved a new device is an entirely different proposition than telling the world you’ve just dished a warning letter to a device maker.

FDA has on the whole been notoriously slow to issue guidances on social media, so one might be inclined to accuse the agency of hypocrisy in its reluctance to write those guidances even as it speculates on the use of social media for compliance/enforcement.

Indeed, the long-promised social media guidance from the Center for Drug Evaluation and Research bears a strong resemblance to Microsoft’s Windows NT 5.0 operating system of the 1990s. Microsoft’s laggardly release of NT (aka, Windows 2000) needled some software developers to describe NT as Windows Not There. I’ll leave it to the reader to come up with a word that means “vaporware” in FDA-speak.

If drug makers are getting antsy waiting for Godot, device makers might want to switch to decaf because Jeff Shuren, MD, director of the Center for Devices and Radiological Health, told me at a session toward the beginning of this year that CDRH is not even considering a social media guidance, and indeed, the CDRH website lists several potential guidances for 2012. A social media guidance is not on the list.

So why should industry worry about the lack of a social media guidance? After all, Medtronic has Twitter and Facebook accounts, and they’re not alone.

One big part of the problem is that FDA is not the only party of potential interest. A device maker that uses Twitter to announce a new 510(k) may discover a court thinks the entire label should appear in that 140-character entry. And anyone who claims they know everything they’ll ever need to know about disclosure – whether we’re talking about FDA or the Securities and Exchange Commission – either brilliantly predicted the outcome in Matrixx v. Siracusano when the suit was filed in 2004 or is just blowing a lot of hot air.

There’s no need to spell out the role of FDA guidances in legal proceedings, but we all know those guidances often play a crucial role in outcomes. So let’s just end with this: Information technology has entered the second decade of the 21st Century. Isn’t it time FDA did the same?

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