Regulatory Stockholm Syndrome

On Tuesday, I was pleased to participate at DIA’s “Marketing Pharmaceuticals” conference.  (More on the full meeting can be found here.)

I was on a panel entitled, “Updates on Social Media: Industry/Agency Perspective.” It came after presentations by DDMACers Tom Abrams and Jean-Ah Kang – neither of which gave any reportable updates other than that the agency is working on “multiple guidances,” with the first one being announced (maybe) in “the first quarter.”

In fairness to both Tom and Jean-Ah, they really can’t say anything other than “we’re working on it.”  And they were good sports when faced with frustrated questioners straining for even a teensy sliver of a prescient tea leaf.

Jean-Ah presented data showing the continued increase in DDMAC pre-review requests (both electronic and otherwise). With the very real likelihood of decreased Congressional appropriations and zero chance of DDMAC user-fees, perhaps Abrams and Company should consider hiring Watson.

The panel on which I participated was ably moderated by the Silver Fox of healthcare marketing (aka -- John Kamp of the Coalition for Healthcare Communication) and also included Mark Gaydos (Senior Director, US Regulatory Affairs Marketed Products, sanofi-aventis), Leah Palmer, (Executive Director, Regulatory Affairs Amgen), and Paul James Savidge (Vice President & Associate General Counsel Bristol-Myers Squibb).

I kicked off the panel with the following comments:

The Five Misunderstandings of Regulated Social Media

The use of social media by regulated industry is faltering because of fear, timidity and misunderstanding.

I’d like to make five main points that are often overlooked or misconstrued when we discuss social media in the context of regulated speech:

1- There is a difference between online advertising and social media

When the FDA sent out the “famous 14” warning letters on sponsored Google links, many pharmaceutical regulatory review professionals said, “See, told ya – you can’t use social media,” and breathed a secret sigh of relief – another sign of an ever-growing regulatory Stockholm Syndrome.

But they were wrong, because when you read the letters it becomes quickly evident that DDMAC equates “sponsored links” not with social media – but with paid advertising.  In the context of those letters, “sponsored” equals “paid.” And there are rules for that.

Beware, because as Disraeli said, “A precedent embalms a principle.”

2- There is a difference between social media platforms and social media content

FDA sent out a warning letter regarding a YouTube video where a paid celebrity spokesperson said that a drug had “cured” her disease (a decidedly off-label claim, shades of Dorothy Hamill and Vioxx). And many internal reviewers industry-wide said, “See, you can’t use YouTube. Not so.   If the content is non-compliant, then it is non-compliant regardless of platform. On the positive side, I believe the reverse is also true.

DDMAC Director Tom Abrams has made it clear that when there is guidance from the agency on social media, it will NOT include agency direction on how to use specific platforms such as YouTube or Facebook or Twitter – and that includes emerging mobile platforms too.  

3- The fear of adverse event discovery is dangerous and misguided

As recently as last November, one large pharmaceutical company told me that their official policy was not to monitor social media sites for fear of unearthing adverse events.

This would not play well in a newspaper story or in front of a Congressional subcommittee.Industry’s regular and public social media “AE-phobia” only reinforces the public’s erroneous notion that industry communications are solely about money and marketing – and the public health be damned.

If industry is not afraid to mix it up in real time with real people – then it needs to walk the walk. Social media abhors a vacuum.

In 2011 we must embrace and rejoice in social media’s capability to unearth adverse experiences early and often. Quod erat demonstrandum.

4- The fear of user-generated content and off-label conversations is real … but

There are a multitude of solutions, ranging from moderating comments (which are generally accepted by social media communities as long as they understand the necessity for such moderation) to corporate responses directing the user to a given product’s PI.

But these tactical solutions don’t solve or even begin to address the issue of “property owner” vs. “property user,” an issue that was mentioned by the FDA in its Federal Register notice for its November 2009 Part 15 hearing.

That’s an issue that DDMAC would be wise to address in their forthcoming guidance to industry.

5- Who’s responsible for what?

Social media is a big place, can any single company be held responsible for what’s said about itself or its products anywhere on line?

Consider the current on-the-books guidance, which reads, “Applicants should review any internet site sponsored by them for adverse experience information, but are not responsible for reviewing and internet sites that are not sponsored by them.”

But what does “sponsored” mean?

Consider the oft-heard TV voice-over, “This portion of the Masters is sponsored by (NAME OF ERECTILE DYSFUNCTION PRODUCT).

Nobody in the viewing audience thinks the sponsor chose the speed of the greens or the pairing of the golfers, or the height of the rough. But say “sponsored” on interactive social media and watch the sparks fly at internal regulatory review.

Tom Abrams has said that DDMAC guidance will address corporate responsibility for correcting and monitoring third-party sites for misinformation. It would be very useful for DDMAC to also clarify, among other things, what “sponsored” means.

Let me be blunt – expecting a regulatory Holy Grail will only lead to disappointment and frustration.  And blaming the FDA when that happens won’t make anything better or move the social media agenda ahead any further or faster.

Social media is the new frontier.  It is the crucial grade that exists between regulated speech and user-generated content.  In the 21^st century, it is where the rubber meets the road.

Social media requires interactive engagement in real time.  It requires you to play rather than purchase.  And that’s a wonderful opportunity – because you cannot purchase passion.