Nick Cifuentes

The Pharma battle has been one of the more entertaining enigmas surrounding social media within the past several years, and without question, still very much unsolved. When carefully thought out - it’s one simple question - how should Pharma marketers approach social media?

Since the dawn of social media marketing (used loosely), Pharma brands have found social media - nerve-wracking - nervous to dive head-in to large social media programs.

Scenario: Imagine you created a drug that could cure the common cold. Then imagine it did just that. Then one day - it stopped working, and even worse - it ended up killing someone. (Dramatic I know, but bear with me). The press picks the story up, Twitter and Facebook explode in negative mentions, and blogs begin to slam the creator of the new drug, Izroda (company made up for literary purposes). Forum discussions pile up and viral videos mocking the drug surface, all while the the Pharma brand Izroda just stands there, helpless - shackled by the FDA’s guidelines.

This is what Pharma brands are worried about, the “adverse events” that can come from consumer discussions. Brands such as AstraZeneca, Novartis, Vertex Pharmaceuticals and Boehringer Ingelheim are all worried about the off-label uses, chances for incorrect information about drugs and drug marketers to end up on third party sites, this all increases the potential for negative fallout from social media activity.

However, these brands are not completely frightened of social media, some have been dipping their toes in social media for more than a year now, but treading very lightly. They have been experimenting with platforms like Twitter; in addition, some have been more involved using viral, crowdsourcing strategies to accomplish a variety of things. They are improving customer engagements with their brands, delivering important information, educating, tweaking brand perceptions, and have been monitoring and analyzing consumer-generated content.

“[Pharmaceutical marketers] need to ask whether their social media program is good for marketing and good for public health. If they can’t answer yes, then they shouldn’t be doing it.”

In a recent interview with eMarketer.com, Pitts helped clear up some lingering questions about the FDA’s expectations to issue guidance on the use of social media in 2010.

“There are a lot of ifs. The first if is, is this really a good thing? A lot of times when you ask for regulation and you get it, you may not be happy with it. If marketers are waiting for FDA guidance with the assumption that it’s going to make their jobs easier, that’s very much open to question.

When you look to a regulatory agency that is very strong on science but just mediocre on social science and you ask it to think about issues as complicated as social media, it’s a real crap shoot. Will the FDA actually choose to write guidance or will it be a draft guidance? And if so, what will it focus on? My best guess is that the guidance will deal with very low-hanging-fruit issues.”

And will Pharma marketers receive the guidance they need to feel more secure about participating in social media in 2010?

“If the industry thinks the FDA is going to come out wit

h thoughtful and complete guidance on how to use social media in 110 different circumstances, it’s going be very disappointed. The FDA is going to take baby steps to move forward. Those who think that they’re going to receive a document that answers all their questions simply do not understand the FDA process.

The most important thing to understand is that everybody, including the FDA, realizes that social media is where the people are. Drug companies want to engage with people on social media sites. But I think the key question is what is and what is not regulated speech. Regulated speech is generally a very specific thing. I don’t think anybody wants the FDA to say that all health-related communications on social media is regulated speech.

When it comes to guidance, the problem is that the FDA embraces ambiguity because ambiguity gives it tremendous power and elasticity to change its mind given the circumstance. What pharmaceutical marketers are doing is waiting to see what the FDA says and then they’ll act accordingly. However, if the guidance the FDA comes out with isn’t some King James version of the Bible that everybody’s hoping it’s going to be, and it

certainly will not, the question then becomes, which marketers will step forward and choose to be more aggressive than they previously have been?”

Pitts said his best guess is that the FDA will end up clarifying some things and “muddy others,” but not really give anyone a clear picture. In the end, it will be up to the drug companies to make the choice on whether they move ahead with social media. The big issue that remains foggy is what is regulated and what is not regulated.

“The key point is what is regulated vs. unregulated speech. If I am a patient with arthritis and I am speaking on a social media site to another patient who has arthritis, that is not regulated speech. If, however, I am talking to one patient who has arthritis and I have arthritis and we’re speaking on a site that is sponsored by a drug company, is that regulated speech? That’s very much up in the air.

If people talk to each other and there’s no money exchanging hands, that is not regulated speech. Whenever the FDA has been taken to court on First Amendment issues, it loses. So the FDA is being very cautious about avoiding what’s called “regulatory creep,” which is a way of trying to regulate things that it is not intended to regulate.”

One key outstanding issue that truly keeps Pharma brands from diving head into social media centers around drug companies correcting misinformation on internet properties they don’t own.

“Right now, a lot of companies feel that if they go onto a site to correct a mistake they will be seen as being responsible for everything else on that site. So, for example, a drug company goes on a website and says “Hello, my name is Tobi Elkin and I work for Pfizer. I saw something on your website that’s not correct.” You can offer the site a link that goes directly back to your website, which is vetted by your attorneys and completely appropriate. That’s what I would call a regulatory green zone-total transparency. I would like to see more of that.

Even something as simple as that is oftentimes seen as overly aggressive by a lot of companies. There are other companies who have as their official procedure that they will not monitor sites that they don’t control for fear of unearthing an adverse event. That may put them in compliance with the letter of the regulation, but if a reporter from The New York Times called and asked “Do you have a policy of not looking for adverse events on the internet?” and they said “Yes,” they would look pretty silly and it would sound even worse in front of a congressional subcommittee.

So the concept of being in compliance vs. doing the right thing for the public health cannot be contrary to each other and right now they are. The issue is to step up to the plate and do what’s right instead of what is legally conservative.”