Former FDA Official to Pharma Marketers: Don’t Expect Much Regulatory Guidance on Social Media

Peter Pitts was associate commissioner for external relations at the Food and Drug Administration between 2002 and 2004 and helped draft the most current guidance on direct-to-consumer pharmaceutical advertising. He also testified at the FDA’s hearings on social media in the fall of 2009. He today serves as president of the Center for Medicine in the Public Interest and is partner/director of global regulatory policy and health initiatives at Porter Novelli. I recently chatted with Pitts about drug marketers participating in social media and the prospects for regulation in the space.

eMarketer: The FDA is expected to issue guidance on the use of social media this year. What do you think it will look like?

Peter Pitts:

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 Will the FDA actually choose to write guidance or will it be a draft guidance?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.

eMarketer: Do you expect that marketers will get the guidance they need to feel more secure about participating in social media?

Pitts:

If the industry thinks the FDA is going to come out with 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?

eMarketer: And what is your best guess on possible scenarios?

Pitts:

My best guess is that what the FDA says is going to clarify some things, muddy others but not really give anybody a sense of clarity. Then it will be up to the individual drug companies to decide how they choose to move forward. The most important thing is to use social media to advance the public health. To let the issue lie because of inarticulate, ambiguous regulations certainly is in nobody’s interest.

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.

eMarketer: Presumably your clients are all at different stages of their social media usage. How do you advise them?

Pitts:

They need to ask whether the program is good for marketing and good for the public health. If they can’t answer yes then they shouldn’t be doing it. But if they can honestly say “Yes, our program in social media advances the public health, helps to educate the public, helps to move safety and compliance forward,” then they should go ahead and do it with appropriate safeguards in place.

So it isn’t simply a question of looking at social media and viewing it as a powerful marketing tool, which it is. We advise our clients to look at it simultaneously as a strong public health tool.

eMarketer: In your mind, how closely tied are online advertising and social media issues for pharma marketers?

Pitts:

They have been linked but they need to be completely different. There are rules in place that govern advertising, whether it’s on a billboard or on television, magazines or online. And those rules apply regardless of media and they work. When you think about an online banner ad or a sponsored Google link, those things are not social media, those things are advertising.

Social media means something completely different. Assuming that they’re both the same thing because they both are on a digital format is a tremendous mistake. From a regulatory perspective, it’s very clear that a sponsored Google link is a paid ad. Online advertising is regulated the same way as any other advertising is regulated right now. I don’t see any need for more rules. The current rules fit and apply very nicely.

eMarketer: How and when should manufacturers be responsible for correcting misinformation on internet properties they don’t own?

Pitts:

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.

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