DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

Social Guiding Principles Summit

An Overview of Legal in a Digital World David Ralston Gilead Sciences

The following presentation took place at the Digital Health Coalition 2012 Summit in New York, NY. Thank you to David Ralston for speaking at this event and making the event, conversation, and subsequent innovations possible. The Digital Health Coalition, a nonprofit organization with 501(c)(3) status, was created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services.

DISCLAIMER The comments and opinions expressed in this document are the comments and opinions of the individuals and do not reflect or imply an official endorsement from any company, brand, or employer.

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

David Ralston Senior Director, Business Conduct

For those of you that dont like legal to be present Im not your typical legal. What I mean by that is I try to look for solutions and I do believe that many of us in the industry have been doing that for a long time. You guys clearly are showing your stripes by saying were not going to wait for guidance. Were not going to wait for the law to change or become clear. We are going to go ahead and push for it. I love that idea. I come from a much smaller company than Sanofi. We have four thousand people worldwide, which means the whole digital task force is in the room, Tina and myself. Were trying our best to come up with guidelines and principles to follow -- but what I want to do today is talk about what the law looks like currently and then what law we have received recently and how it would apply to the various guiding principles that we have. We wont go through the ad promo rules in general but of course those are out there. Pharmacovigilance -- as stated earlier -- you already know. Adverse event reporting should not be that difficult for people to get their arms around. We know how to do it. We know what to do. But clearly the issue of control and whether we control of a website which means do we monitor it, which means are we responsible for every single thing that comes out of that website? Frankly, the bottom line becomes the ones you choose to monitor -youre in. Right. So if thats what youre going to do youre going to have adverse events that come up. Youre going to report them. Its not that difficult. Whats really interesting though is not speaking to the lawyers about this but speaking to your pharmacovigilance people who are trying to explain to you this idea that pretty much anywhere; sitting at this conference, sitting in a hallway, driving in your car listening in on the radio, anything coming at you is essentially a possible adverse event. Right, which means anything coming at you, is a possible opportunity for recording. So that hasnt changed with social media or otherwise. But this guidance on responding to unsolicited questions, I love the comment or the question that was just given to us. What does that mean for on-label because for those us in the industry that have to worry over this stuff from a legal perspective we read this guidance and were like oh, my goodness, theres something here, finally something here that we might be able to understand. For those of you that are thinking like normal human beings your answer might be but it only addressed off-label. So whats the deal with the on-label? And thats exactly

Copyright 2012 | Digital Health Coalition | All Rights Reserved

DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

what you come up with and its fascinating because its says to me its very difficult to write guidance, regulations or other things that are going to reach the broad audience and thats when were going to need groups like the Digital Health Coalition and perhaps PhRMA -and others -- to continue to sort of elucidate the whole idea, the big picture for us because I think thats important to be able to get through yourself where you need to be. Clear and useful FDA guidance -- the clearest in the world. So I stopped there as a bullet point. Just clear and useful FDA guidance. Imagine the idea. Oh, but on the use of social media and direct advertising and promotion with examples and case studies, I mean we could have that. We can have that. Right, we can have that from an FDA perspective. We might have that from these guiding principles. We might have that from a coalition or other working group. But in general, what I pose to you is that all for all the various guidance documents that were planned -- we only have this one. The first one -- answering unsolicited questions. But Im telling you its the clearest guidance Ive seen in my career coming from FDA in terms of its describing examples and case studies, in terms of its giving us a back and forth conversation. Ive found it helpful. You know, it didnt have pictures ... I grant you that but it did have a lot more useful ways of thinking through things than Ive seen before. So the seven principles that weve described are longer on this piece of paper. Ill just go through them briefly in terms of the way I though about them. We encourage participation socially - yes. If you have control you have responsibility. Report your adverse events. Not a problem. Disclose your identity. Were not hiding behind the Internet wall. Respond timely - whatever that may mean to the company. Correct misinformation. Appoint the patient liaison. So these are very simple to me ways of thinking about our interaction in our engagement in social media. What they say to me though is that if youre looking for all seven principles to be elucidated in regs, were not there yet. At the present time, thats fine because again as Sanofi has said we can look behind the regs over here. How am I going to act can be an interpretive way of thinking through and frankly applying your mind rather than being passive and waiting to be told exactly what to do. And I like that.

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

So lets look at the guidance itself though in terms of how its phrased. Its phrased as unsolicited requests, of requests for offlabel information in essence. Its broader than but includes answers regarding electronic media, social media specifically including case studies on Youtube and Twitter. So this came out as the Christmas surprise as we call it or the New Years surprise and when it came out it was so funny because I got it from somebody in medical information. Does this change things? The way the guidance is written it says were basically confirming everything weve told you in the past just in a different presentation form. I would disagree with that. I think its actually giving a little more but none the less. Does it change things? Yes, it causes you to want to look at it, review what youre doing and decide. Does it have any specific rules for you to follow now or is it informing your decisions going forward? That would be my answer to the does it change things. Its very specific about encouraging participation. In no way does it come off as the FDA saying -- we dont believe your participation in social media for instance should be squelched. Its instead saying look, youre capable. In fact, weve said a million times youre the ones who have the ability to respond to requests about your own named products in a truthful non-misleading and accurate manner. We can do this right, says the FDA. I like that. It says though that generally speaking the whole point of this guidance is when you do participate how you do it publicly or privately. Public and private, those are commonly understood terms. Lets just use those. Public or privately is the issue. So what weve framed as one of the core topics for the group here is this issue of control and that which we have control over we are responsible for. Right. I would argue that while control is a hot topic for us here -- and one that were going to continue to look for more guidance on -- this particular guidance is not the one that answers that question. So basically its talking about solicited versus unsolicited questions and its saying that those things that are solicited, essentially Im out there putting myself out there as the pharma company. When I solicit information back from you I have to respond to you on-label. Nothing new -- or different about that. Whether we like it or dislike it, it is a consistent theme that youre going to see. Then if its unsolicited you have to decide if this is a private or a public request and Sanofi just described to us the whole idea. But if its unsolicited, if its private I can answer that private request offlabel and what do I mean by that. I can give the right information privately to the one individual coming from the right part of my company in order to answer that question truthfully and with all the

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

information I have. If its public I cant publicly respond off-label. So I say no response here. What I should say here is I cant publicly go off-label just because its been asked of me. What we should really look at is on this public site the question becomes how much can I fit into that public response? In my opinion, since I know I can publicly describe things onlabel, right, since I know that I should only be answering that which has been asked meaning if its a completely broad disease state question I am not answering about the benefits of my drug. But if Ive got a question about my drug and Ive got a public arena in which to answer a question about my drug I can say on-label things about that drug and to the extent that this question has an off-label component to it refer them again to my medical information place. So its given me an opportunity to sort of fill in some of the gap there rather than just stand back and shake my hands and say theres no guidance. Right, which is a good thing. So again its not about control in this particular guidance but it is about public or private. Adverse events, again its silent because it does not seem to need to really go into something that we already know how to do. Definitely disclose identity, broadly presented and supervised public responses to answer unsolicited requests, should clearly disclose involvement with the particularly firm. It doesnt talk about responding timely per say. I mean its not directly on point there but generally speaking I would say that the way in which these are written to say ... Its interesting because our writing was on those sites with which we have control where we would ask us to respond within a reasonably period of time. So again youre left with a monitoring aspect. If you are a huge company over here with billions and billions of dollars and lots and lots of people youre monitoring aspect might be much more robust than a smaller company who doesnt necessarily have the ability to dedicate all of those resources and time. I think the question has to become sort of how I can fit these activities into currently described job titles and currently enumerated actions that Im responsible for. If you want to be in this make people do double time. Make people do double duty because you could just say I dont have the bandwidth or the head count I should say or you could say well, Im expanding your requirements over here to do more. I think thats one of the things I like about my particular company. Its just that we do often ask people to do more with less. Thats neither good nor bad but it just is and its something where you can challenge yourself to figure out how can I do more with less. Just saying I dont have the head count is not enough necessarily.

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

In terms of the guidance itself it doesnt really answer this idea of correcting misinformation with some kind of broad banded safe harbor. It says you can answer anything thats wrong and go for it. It instead says, look its not a safe harbor to this but if its a public forum that you have misinformation posted on you cant proactively discuss that misinformation from an off-label perspective but you can respond privately, direct them to the right place but again dont forget the fact that you have the ability to discuss on-label. If the correction can be on-label correct it in that manner and go for it. You have plenty of ability to do that already and nothing in the guidance would change that. And then this idea of a patient liaison is silent in the regs but I love the idea that its again a question of just your ability to expand bandwidth, your ability to give people further things to do with less perhaps. What I want to direct you to in terms of what could be, its just a concept. Its not a given but if youve looked around weve talked about European efforts a while ago. If youve looked around and looked around the world were not so unique to have come up with this idea of having to worry over social media. Other countries have indeed done so and even though these countries may not be ones where you can do direct-to-patient advertising theyve none the less looked at the ideas behind interacting with the public and come up with ways that I think are very interesting. And one of the things about Australia is that they have a code of conduct just like the pharma code. Its about twenty pages. But then they have the code of conduct guidelines which are like a hundred and twenty pages and I love that because its again, its a voluntary group coming together of pharmaceutical manufacturers to explain sort of what they think all of this means and Ill give you a link here because it includes in their world and Im not going to go through this but just this is the level of detail they get into in their voluntary guidance. All right. They go through different advertisements and pull up how big the font needs to be even. In a way theyre filling in the regulatory gap in some sense and coming up with a consensus statement on the ways in which you should look at advertising at least in their country. So conceptually in a way our goal has been broad and our goal has been macro in terms of hitting all the high level topics. I understand that. I hope theres also room for innovation rather than waiting for regs, rather than waiting for the perfect answer from FDA -- that theres also room for us to become a little more micro in some of the ways we come together and help with guidance. I think that can be a good thing.

Copyright 2012 | Digital Health Coalition | All Rights Reserved

DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

So in terms of this guidance that weve got now its written purposely to sort of catch all comers. The query is the different guidance needed or tweaks needed or internally that will be done based on the company type. So a primary care company for instance thats focused in a way on much more direct to consumer and similar advertising. It may have a more of an interest in really pushing boundaries in this area or at least getting lots more clarity internally in this area than a specialty care-focused company -meaning one that doesnt have a lot of primary care. The principles themselves you know, are they useful in both instances? I would actually argue sometimes theyre even more useful. Patient liaisons might be more useful for instance in a specialty medicines case. Adverse events may have a greater impact frankly in specialty medicines case and therefore something youve got to attack greatly. But its just a query to the group to remind yourselves that one size cant necessarily fit all -- but maybe the better way to phrase it is once you take this back into your company youre tweaking it purposely to fit the situation you face.

Copyright 2012 | Digital Health Coalition | All Rights Reserved