FDA’s engagement impresses in wake of social media hearing

November 17, 2009 – 3:30 pm by Steven Niles

I had a chance to catch up with John Kamp, executive director of the Coalition for Healthcare Communications, to get his post-game analysis of last week’s FDA hearing on the pharmaceutical industry’s use of social media. Overall, Mr. Kamp was pleased with the presentations made by the industry and the ideas that were brought to the table. More importantly, he was gratified by the astute questioning from FDA, which clearly showed those at the agency were paying attention and demonstrated a desire to find solutions. Although he doesn’t expect a full guidance any time soon, he expects the agency to offer clarity in more indirect ways on some of the particular issues keeping the industry up at night.

My full conversation with John Kamp follows.

Med Ad News: What was your assessment of the industry’s performance Thursday and Friday?

John Kamp: I thought it was pretty good. The regulated companies and their trade associations actually stepped up. Several companies – Pfizer, J&J, Sanofi-Aventis, Lilly – all had pretty good testimony. I was particularly pleased that PhRMA was able to put a specific proposal on the table, and it received a lot of discussion. They were essentially trying, as we were, to get some discussion around ways to get the FDA regulated communication more easily available to consumers and others, and I thought it was a positive step to make that proposal. AdvaMed was also there, very serious about their matters. The media were there. So, I think it was pretty important. One of my colleagues [Peter Pitts, of the Center for Medicine in the Public Interest] called it the Super Bowl of Part 15 Hearings, and I think that might be right.

Med Ad News: Do you think it was a generally fairly unified voice, or were there dissenting opinions?

John Kamp: Unified voice? No. We’d all be suspicious if that were the case. But not so much dissent. People had different ideas. The industry and even the consumer groups did coalesce around some basic ideas, and one of those would be that FDA must enable companies to more aggressively operate in this space. That FDA shouldn’t expect that individual drug, device, and bio companies can control everything on the Net, particularly what goes on in the social media space. That instead it ought to be that if you’ve got control, then you’ve got responsibility, and you must take that control when you’ve got it. But if you don’t have that control, you don’t have responsibility. There were quite a few ideas about how to, in effect, develop a one-click away or a solution that more effectively enables companies to do the best they can to get people to read the contraindication information. So, there was a lot of agreement, I think.

And I was impressed that FDA – although this is a Part 15 hearing where they can’t telescope or make policy –asked some awfully good questions. They were listening, but it was active listening. And I was impressed by both the care with which they listened, the kind of questions they asked. These lead me to believe that they’re paying attention. They know they can do better, and they are going to.

Med Ad News: That’s an interesting point you raise, because like you said, they weren’t there to talk, they were there to listen. But in terms of the questions they were asking, can you give me a sense of the issues that seemed to be important to them or that registered with them enough to question?

John Kamp: Well, we can just use the PhRMA proposal that there be some kind of device on banner ads that enable people to immediately go to the contraindication information. They asked a lot of questions about it. My guess from it is that although the idea of doing this was one they thought was interesting, the idea of making it an FDA related icon is a non-starter. But doing something like that, I think they’re taking it into serious consideration or they wouldn’t be asking the questions.

Med Ad News: So, in general, a productive couple of days?

John Kamp: Yeah. I think FDA is likely to make some things clear. None of us expect, as one of the speakers put it, to see a package to industry under the Christmas tree with a new policy in it. Things like that don’t happen in the government. But there were a couple of things that the people asked for that the FDA has already been pretty clear about, and I think they can continue to be pretty clear about that.

One of them is this whole idea that, although there is a lot of concern in the industry that they might be held responsible for things they don’t control. I’ve never heard the FDA say that. And I expect them to say that that’s not the case in public speeches. The adverse-event reporting stuff is not an issue of DDMAC for the most part. It’s being driven by company lawyers. But for FDA to be real straightforward about that there’s no expectation that companies be responsible for things that clearly the responsibility of the individual people on the Net who are using their browser or that they somehow stop things from being put on the Net by third parties; they’ve never expected that. For them to say that straightforwardly, I would expect to hear very soon.

Med Ad News: Even prior to some kind of official guidance?

John Kamp: Yeah, I think they’ll be more straightforward. Not so much DDMAC staff, but Bob Temple, who is very important in these areas, has been talking very openly and straightforwardly about the adverse-event reporting stuff and telling companies, “Stop telling us all this information that’s not useful.

Med Ad News: Why do you think FDA did this now, as opposed to years ago? Is it just because they’ve finally caught up, or does it have to do with the change of administration?

John Kamp: There is a growing realization that the Net is a different medium and needs specific focus and understanding. I think for the most part this was probably considered and planned well before the election, frankly. Did everybody check with their new bosses before they went forward? Yeah. People do that. But I think it’s just a growing realization that they need to pay attention.

Med Ad News: The time had come.

John Kamp: Yeah. And maybe we wish it had happened earlier, but it didn’t. But now that it’s here, let’s embrace it.

Tags: communications, FDA, hearing, Internet advertising, Social media