DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

Social Guiding Principles Summit

An Overview of Regulatory in a Digital World Mark Gaydos Vice President, Sanofi-Aventis
New York, NY

The following presentation took place at the Digital Health Coalition 2012 Summit in New York, NY. Thank you to Mark Gaydos 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

Mark Gaydos Vice President, US Regulatory Affairs Marketed Products

I appreciate the Digital Health Coalition having me here as part of the event and Im really looking forward to the other presenters as we go through the day and hopefully there will be some rich discussion following from it as well. You know its not often that regulatory gets to be at the beginning of the agenda. I think often regulatory is the necessary evil at events and theyre sort of tucked in at the end like we have to get the kill joys on the agenda here but I do appreciate being put upfront in the agenda. I looked at the title of my slides and I thought to myself; social media engagement in the absence of FDA guidance. That probably is a title that would apply to just about every regulatory presentation in this area for the last several years. Its always how do we do it without the FDA guidance? This isnt going to be rehashing that; maybe aspects of it but really its more about Sanofis experience, a high level overview of what Sanofi has decided to do in this space in terms of engagement. I just think its important from a regulatory background -- or a historical perspective -- to mention a few things and why this is even an issue. You know when a company disseminates information about its products -- or has someone do it -- the FDA would generally look at that and consider it promotion. There are exceptions obviously. There are things like scientific exchange, responding to unsolicited requests where FDA said if thats done appropriately its not promotion, but most of what we disseminate about a product would be considered promotion. And then the regulations that govern that communication specific to promotion They were written decades ago -- in the sixties.

So like the 8 track tape was probably an advance in technology at the time and certainly they didnt anticipate the issues wed be facing with social media; so space limitations; 140 characters on Twitter; the real time nature of the dialogue.
You know traditionally promotion is one way messaging, radio ads, print ads, TV ads but its not the interactive real time back and forth and that creates some challenges. And then I think its important to remember that we -- and the FDA -- have been down this road

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

before over a decade ago. FDA abandoned guidance on the Internet and I would argue it was basically because of the concerns around the rapidly changing technology. They would have issued a guidance that was immediately obsolete the day it was issued. Well, thats not much good. I would say the challenge is probably greater now. Certainly technology is not slowing down in terms of how it evolves. Even existing platforms change and you know Facebook might change its policy on certain things. From time-to-time we have to adjust. They will have a harder job -- but I think - as youll see - theyre biting it off in smaller chunks and not trying to do an all-encompassing guidance. So the challenge is really how do you provide something thats specific enough that its meaningful and companies can actually implement what it suggests if they agree with it and how do you make sure its general enough that it doesnt become obsolete.

A specific guidance on Facebook would probably be a bad way to go or something specific on Twitter. Its going to have to be something that could be applied pretty broadly but also specific enough that its actually useful.
I would just throw out also that in 1997 FDA issued guidance on DTC broadcast ads. The reason I mention that is I think thats the kind of creativity that we would expect from the FDA. You had the same regulations -- and in terms of providing the prescribing information with advertising, how do you do that on a broadcast ad aside from painfully scrolling a package insert on TV? Well FDA came up with alternate means to provide that. So I think thats the kind of flexibility thats required here for some of the challenges. And these are the requirements. You know about the requirements and the things that cause some problems when we want to talk about products in the social media space. You have to say what your products are used for. You have to talk about any limitations, provide balanced information, a presentation of risk and benefit -- and for some products and some categories of products this could be quite difficult; black box warning products, etcetera, access to full PI. And you know generally we achieve that with hypertext links so I dont know if thats the most difficult one. But the last thing I want to mention here is submission at time of first use, which is a regulatory requirement. Well, how do you do that and maintain a real time dialogue? Certainly there are specific challenges around that. Well, as of late December we cant say FDA has issued no guidance or that theres a complete absence of guidance. Although not a social

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

media guidance per se, they did issue a draft guidance on responding to unsolicited requests for off-label information specific to marketed products. And while its not specific to social media it does touch upon it and provide basically a position which has been verbalized by the FDA before -- but now its in writing regarding a public request for off-label information by an individual in a social media setting or even in a promotional speaker meeting. The response to that off-label request should not be to the entire community. At least it should not contain any off-label content. Rather that should be a one-on-one. The response should always be a one-on-one personal interaction. So if someone asked an offlabel question on a third party community, directed at somebody from the company whose product is mentioned, FDA would argue they shouldnt go in there and respond with the off-label content in full view of the community. They should provide a contact number so they can contact medical information at the company. Fulfilling your requirements when using tools with space limitations. Twitter obviously comes to mind and you know I dont want to be a killjoy but this may be a space that product specific content is not shared. Again its the technology industry; the FDA did not set the forty character limit. Its there. It may -- as it is now -- generally be used for company news, a lot of company communications are out there -- or disease type of discussions. That said, the FDA can come up with some flexible mechanism. It may not be a place where you can have all your product information, put in your risk information, because it just doesnt allow enough space.

Postmarketing submission requirements I spoke about this when I mentioned time of first use. I think wed like the FDA to clarify whether that can be broader than just you can use your material the day it was submitted. Its going to be something that enables conversation to flow especially if it is a branded conversation that would be considered promotional in nature.
Number four here -- I think is one of the trickiest ones and this gets at what Mark was talking about before about control. But its beyond control. So what is the sponsor accountable for in social media? Certainly you could argue that the content you create and push out -and when you disseminate posts, its pretty clear. The question is how far does the companys responsibility go once it posts the information, lets say on a third party site and somebody chimes in,

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talks about the product, talks about it off-label? And does it matter? Do the companys initial posts change the responsibility?

So if a company goes out and posts information about a product that might be quite different than posting something about disease statistics and somebody chimes in and talks about the product. You know I think thats why FDA is struggling with it because where do you do draw that line? I hear the same arguments Mark made that were responsible for what we post but the ensuing conversation is free speech and its others but did we prompt it and are we responsible for the things we prompt?
Im not going to spend much time on links and correcting misinformation. I think Mark already addressed it. Whats the scope of what you choose to correct? Anything thats wrong? Incorrect information that poses a health risk? Is it information thats damaging to the companys image, etcetera or is it all the above? If so, if a company is in are they all in? Everywhere and anywhere you see this information are you now bound to correct it? Im not sure what the answer is to that because its certainly beyond this regulatory question. So what do we do now, now that we have a little bit of guidance but a whole lot thats not answered in terms of where FDA is on these issues? We could pretend were not in the digital age and pretend that social media doesnt exist and not engage. I dont think were proposing that. Clearly we cant blame the FDA for not engaging. Thats not fair either -- you can work within the regulations. You could do as much as possible and strictly apply the existing regulations which weve already talked about being outdated and not addressing some of the specific nuances and concerns of social media. Or the companies can provide guidelines that interpret those regulations for the modern day. And I think thats what were trying to do certainly at Sanofi. Not that we have all the answers and there are surely things were still not doing until we have some guidance but I think to sort of go silent and not engage is not going to help. We have members of our social media team at Sanofi here today in the audience: Jim Parker, Allison Gassaro and Joan Mikardos -members of the Sanofi Social Media Task Force. And this is really the group that drives the engagement and at least creates those

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guard rails as Mark describes -- how we should engage, who should engage and its made up of the different functions that you see listed here as well as our ad hoc members. This is the group that really develops guidelines, trains on those guidelines to make sure folks that are involved in any company engagement in social media are aware and also even folks that use it in their own personal lives as company employees. And finally -- resolving issues. So either anticipating or reacting to changes such as a changing Facebook.

We saw companies in the industry go silent on Facebook not long ago and I think we were able to keep going because of some of the measures we had put in place in terms of monitoring comments, etcetera. So ultimately this group is looking at finding solutions for enabling engagement.
And I know Mark and I were talking last week and its surprising that something like setting up a group, a cross-functional group to look at this and how a company is going to engage-- that doesnt exist in a lot of companies yet. Its just something thats beginning and you would think at this point it would be well under way. I wont go through every item thats mentioned in our guidelines but this is sort of a bit of a table of contents, a modified table of contents. There are some general considerations. We have terms of use, discussion around sites that we control where we require participants to comply with terms of use and agree to those. Those company postings -- whether theyre promotional or non-promotional, visitor posts and what have you. One thing we do require is that we are transparent, that if a person is representing Sanofi in the online space in the community its clear that they are from Sanofi or acting on behalf of Sanofi. And its not a free for all. And specific individuals are identified who participate. These are folks that know not just the regulatory and legal consequences or the guidelines per se but also how you interact with people in the online space. And you know theres an art to that as well. So its not just regulatory and legal -- so people that are savvy and know how to operate in this space whether its a professional environment or community or consumer community. We also make sure we monitor those sites that we sponsor. Again its something we control and thats what weve chosen to do and that includes our posts.

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And obviously we manage adverse event reports per FDA guidelines and regulations and our own policies within the time frame specified. We do have terms of use that folks are required to agree to and these really lay out the terms if its a site we run, an online community. What is the focus of that site? Is it about disease and if so then we would ask that they not post comments about products or if its about products, lets say if we were to go down that road perhaps, then its only for on-label uses of those products and its not for adverse event reporting. We give them contact information should they want to speak to someone in our medical group but truly laying that out so that if you do have to take comments down or prevent them from being posted folks understand and it may sort of reduce the backlash. We do review our company postings and they can either be promotional or non-promotional. Obviously, if theyre product-related they would be reviewed or approved -- complying with regulatory requirements and submitted at time of first use.

Now what weve tried to do is free up things in a non-promotional area. Where a posting is clearly not promotional in any way we can carve out categories of those types of posts since they dont have to go through a formal approval. So it frees things up and hopefully gets the dialogue going. So if its not really a product-related posting, or it doesnt go into an in-depth medical discussion of any sort where we would want our medical folks to look at it, there are a lot of comments our folks can post and they dont have to go through an internal approval process. And again these are people that are trained. They understand that and it helps to keep the dialogue flowing.
We also address issues around sharing. Such as when Novartis received the letter for sharing Facebook content. They enabled sharing and FDA said the content they shared did not comply. It mentioned the product, it mentioned the use of that product, which is a claim, but they didnt have risk information or a link to the package insert. The FDA said were holding you responsible. So we do review this because we can choose to have sharing functionality or not to have it and if so we should know what were sharing. So thats

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something that weve worked on. So thats all reviewed up front rather than finding out about it afterwards. And Ill just talk a little bit about the monitoring and this is a critical component I think from our perspective and I would imagine many other companies that have chosen to go into this space. Monitoring comments, particularly on the sites you control or a site you have on a third party application such as Facebook, Twitter, making sure youve anticipated types of comments that might be posted. Those are problematic and that might require specific responses. So if someone does post a comment about an off-label use of the product, you can choose to already have a response ready to let that person know We appreciate your contribution. Sorry, but because of our policies we couldnt post your comment because it pertains to an offlabel use and thats outside of our terms of use. You have to handle this sensitively. Also what do we do in terms of triage and safety issues or adverse events that do get submitted despite your best efforts to dissuade adverse event reporting online? So, let me wrap up in the interest of time. We know that commercial engagement in social media may invoke the advertising and promotion regulations at the FDA when were talking about products specifically and that there is an absence of significant guidance from the FDA. We have a little insight. We have to apply the existing regulations. Its ... how can we apply those? Is it the technical letter of the law or the spirit of the law, or something in between? Well, it probably a bit of both but certainly in some cases it is more the spirit that guides us because they were not written with digital media in mind and its important that we develop internal guidelines across the industry to facilitate engagement and ensure compliance and I think continue to engage the FDA.

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