Will the FDA regulate social media? (Q&A)

ASPEN, Colo.--The U.S. Food and Drug Administration started to discuss possible Internet regulations at an event it convened in 1996. Fifteen years later, the pharmaceutical industry is still waiting for an outcome.

A blog post from the Public Relations Society of America last week complained that "it's time for the FDA to act and to properly advise" pharmaceutical manufacturers about what kind of advertising is and isn't allowed, especially on social-networking sites. PhRMA, a trade association representing pharmaceutical makers, said this month that "we continue to wait for FDA's guidance, and to hope that it comes soon."

Complicating matters was Facebook's recent decision to allow public comments on drug companies' products pages, which prompted Johnson & Johnson and others to pull the plug on some of them. Put another way, fear of offending the FDA has led pharmaceutical makers to be overly cautious and shy away from social media--even if they're not violating any law. (On a related note, the Obama administration has said, as recently as last week, that it's trying to roll back unnecessary regulations on businesses.)

This debate is unrelated to Google's recent $500 million settlement with the Department of Justice over accepting ads for offshore pharmacies, a practice CNET discovered that Microsoft, Yahoo, InterActiveCorp, and others have also engaged in.

CNET caught up with the founders of the new Digital Health Coalition last week at a technology policy conference here and talked with them about what they're hoping to accomplish. Below is a discussion, edited for space, with coalition co-founders Mark Bard and Joe Farris.

Q: What problem has the lack of FDA regulatory certainty created?
Bard: Inaction. You basically have a world today where 90 percent of the industry will not experiment in social.

A great example is something as simple as adjacent content. You advertise on 60 Minutes and you don't care what the previous segment was. But if you advertise in a community of diabetes patients, and someone is talking about adverse consequences of your product, there's some concern there.

What's the Digital Health Coalition trying to accomplish?
Farris: We're trying to change the industry. There are three buckets that we're focused on: social media, search, and mobile. Google, on our advisory board, is search. But with Google+, they're mostly interested in social media. Social media is where our advisory board wants us to focus our attention.

What would you like the FDA to do?
Bard: There's no opinion specific to social. The FDA will never issue a very detailed...policy guidance: this is what you should do in social. They're being vague on purpose.

Ferris: They're not going to issue specific channel guidance. What we're trying to do is put together guidance that the marketers can actually use. Right now the challenge is that the legal risk outweighs the benefits to marketers. It's really difficult for the marketers to show the benefits. They're easily shot down by the regulatory committee. The risks are more easily identifiable.

Bard: You can get a warning letter from the FDA.

How many warning letters has the FDA sent out?
Bard: There [were] two sets of events. The first was in search. The FDA issued 14 letters on the same day, saying if you're mentioning the brand name in a Google search ad, you need to mention benefits and risks. It's impossible. There's not enough space.

The second was "liking" a brand. It was deemed as promotional content which didn't have Fair Balance. Novartis got a warning letter on people "liking" a brand. The FDA says if you're liking it, it's a promotion. What that's done is scared the entire industry off of Facebook. [Ed Note: The FDA defines Fair Balance as saying the "content and presentation of a drug's most important risks must be reasonably similar to the content and presentation of its benefits."]

What happened when Facebook required drug pages to allow comments?
Ferris: That was D-Day. Many sites shut down their page. Many others are working on technology solutions behind the scenes. Others kept their pages live and said, "We're going to learn by monitoring comments."

Are you a nonprofit group?
Bard: It's pending. We just formed in June. The government doesn't move quite that fast.

Isn't there a First Amendment question here? Don't drug companies have a right to say what they want in social media, as long as it's not false or misleading?
Bard: Who's going to stand up? We've been sitting around like everyone else for the last five years waiting for someone to do this. That's why we formed this group.

The FDA was created by Congress, and in theory does what Congress says. Why not skip the FDA and ask Congress to clear things up?
Bard: It's not our approach. That's a viable question...

Farris: In an ideal world, we'd put together a consensus document--voluntary guidance--and the FDA would use our guidance.