In December, a day came that pharma marketers have been waiting for for years – the FDA finally began to release guidance on how pharmaceutical brands can and cannot use social media to engage with patients. But the guidance is, well, a little underwhelming. (For a look into the specific actions firms should take as a result of the guidance, Dale Cooke of Digitas Health has put out a regulatory note, it is the best I’ve seen so far)

First, some background, if you’re not knee deep in health-related social media circles. The US Food and Drug Administration, in addition to determining which pharmaceutical products should and shouldn’t be allowed in America’s pharmacies, also regulates the ways in which pharma companies are allowed to market to doctors and patients. Sounds smart, right? After all, we’re talking about potentially-dangerous drugs, here.

As such, they’ve developed guidelines and rules for the use of electronic marketing in a pharmaceutical setting. The only problem is, they haven’t been seriously updated since the late 1990s – and do not account for social media at all. This has put pharma companies in the weird position of being able to use social to broadcast certain messages but unable to have meaningful conversations with their customers, lest a side effect or adverse event is reported, setting off a chain of regulatory red tape.

The FDA listened and, in November 2009, held two days of hearings where pharma marketers, consultancies, doctors and scientific groups testified and gave suggestions on adapting the agency’s guidelines for a shifted communications landscape. And then, we waited – until Christmas Day 2011, when the FDA published this – entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” - in the Federal Register, without even issuing a press release. This particular issue is one small facet of the pharma/social media problem, and it looks as though that the agency, rather than issuing sweeping guideline shifts that acknowledge a new communications landscape, is going to attack issues piecemeal.

But this specific guidance gives very little evidence that the FDA is thinking about social media as a systemic phenomenon, as opposed to a special case, capable of being dealt with with one-off regulations. First, the basic assumption is that marketers will be using social channels to “disseminate product information”, i.e., to advertise. That’s a given, but social offers organizations a lot more than just more space to plaster messages; we’ve talked about how social media trends mirror those in real life, and presumably the ability to listen to consumers better might lead to better health outcomes.

So here’s what I’d like out of future FDA guidances: an acknowledgement that social is a conversational medium, not a broadcast one; that it has benefits for pharmaceutical companies and broader public health outcomes beyond providing a place for Pharma to advertise; and that rigid rules on what Pharma can and can’t discuss in certain circumstances is bound to fail in a landscape where drugs are prescribed for all kinds of purposes.

Maybe we’ll get it, but I’m not hopeful.

One of my favorite reads in the social marketing blogosphere is John Mack’s Pharma Marketing Blog. While John covers pharmaceutical marketing across all channels, his posts on social media present a nuanced look at the unique challenges pharma and other regulated industries face when trying to make headway in the space. Particularly interesting are the surveys he occasionally does of pharma marketers. Add him to your RSS reader, if you haven’t already; he’s also on Twitter here. 

John posted a thought-provoking interesting survey a few weeks back, asking pharma marketers what they thought the most important elements of a social media implementation plan were, particularly in the event of a crisis.  Read More »

The term “emerging markets” is a misnomer—many of these markets have already emerged and are better described as “ascendant markets”.  That much is clear after reading The Economist’s special 18-page report on innovation in emerging markets.  The key takeaway for marketers is that these markets are increasingly the source of commercial innovation (innovation in the way products are taken to market), not just product innovation (innovation in product design and features). Read More »

Crikey! That healthcare legislation was a wee bit contentious. 

One thing we can all agree on is that it will be tough for marketers to predict precisely how the new laws will affect consumer and stakeholder behavior.  Simply put, the sheer complexity of the US healthcare system makes prediction difficult.  Moreover, legislation this sweeping will almost certainly yield unintended consequences, thereby increasing the levels of unpredictability.

How should marketers cope?  Try these two tools.  Read More »

Very rarely does one member conversation spark a complex web of issues, but one yesterday with a senior marketer at a consumer firm in a mature industry did just that.

The firm has reconfigured its entire new product development process, from stage gates, to resource allocation, to organizational structure and ultimately, the locus of innovation – a conscious shift from incremental to disruptive.  Simultaneously, the company placed brand management among its top priorities for the year.  Our dialogue quickly turned to the intersection of the two and which was actually driving the bus. Read More »

By Laura Morris

We recently hosted a conference call that gathered progressive marketers from highly regulated industries (like pharma, financial services, and healthcare) to discuss how companies facing strict legal constraints could make the most of social media.  Here’s what they suggest:

Read More »