Translating the New FDA Social Media Guidance

[Get your copy of the FDA Guidance Translator Flow Chart later in this post]

It’s been a long wait, but the FDA finally delivered. They’ve come through with at least some direction for how pharma companies can properly use social media. It’s not a complete answer to every issue, but it is a good start. I’ve reviewed the full contents of the guidance that the FDA released on December 30, 2011 and found it, not surprisingly, a bit hard to follow at times. The full title of the guidance they released is: “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” Catchy.

I’d encourage everyone to read the full guidance. You can get a copy of the PDF right here: FDA Unsolicited Requests Guidance (1882 downloads).

As my gift to all of you, I’ve tore apart this document and created a simple to follow flow chart that you can use to figure out if you can respond to something and how to do it. More on that in a moment.

What the FDA released is NOT a comprehensive set of “Social Media Guidelines” that some companies and people seem to believe are the holy grail/final barrier to the promised land of social media usage for pharma. Rest assured, as I’ll say it again, you won’t see this anytime soon. You’ll continue to get bits and pieces of guidance like what we just got that points you in the right direction. The FDA is never going to tell you the right way to use Facebook or Twitter. It wouldn’t make sense for them to do this. By the time they created the guidance, the platforms might be obsolete. They could have created guidelines for MySpace if we had our druthers about five years ago.

So, be happy for what we’ve got. I’ve read a lot of commentary from different people on this new guidance and most seem to think that it’s completely useless. These are likely the people who were expecting to give a massive document explaining precisely what pharma could do with every aspect of social media. They’re likely to be disappointed with everything the FDA puts out since this massive document isn’t coming. I think this set of guidance, while limited to one issue, is actually very valuable.

I have a specific interest in this part of the entire social media issue. Way back in November 2009 when the FDA had public hearings on social media, I had the opportunity to testify. The focus of my presentation was on the issue of responding to questions on public forums (i.e., “unsolicited requests”). You can get a full copy of my presentation here: FDA Social Media Hearings Testimony (1635 downloads) You can also watch it on YouTube:

I noted in my testimony that the FDA needs to allow companies to correct inaccurate information online. If the FDA is charged with protecting the public health, isn’t helping to ensure that information people receive online is accurate part of that mandate? In this case, the FDA doesn’t need to ensure the information is correct on their own, they can simply empower pharma companies to do the work for them. You can review my presentation for a few examples, but one that I consistently use in presentation is a question like this from MedHelp.

Instead of getting a quality answer from a medical professional, this person gets a response from someone who still uses a hammer and sickle as their avatar 20 years after the fall of the Soviet Union. Probably not the best source.

“…but I wouldn’t hold my breath.” That’s the best answer this person gets. Wouldn’t it be better for everyone if GSK, the maker of Valtrex, was allowed to do this?

I think the FDA realizes that the answer to this question is a resounding “YES!” And now, they’ve given companies some guidance on how they can answer questions like these. The FDA specifically invited comments at their hearing on this question: “What parameters should apply to the posting of corrective information on Web sites controlled by third parties?” This guidance begins to answer this question. My testimony was about this question and my answer was that there should be five simple rules for companies to follow if they want to answer questions like these. I was pretty pleased to see that the FDA largely came back with guidance that matched a lot of what I suggested. My five simple rules were these:

  1. About your product only –meaning you should only respond to questions that are specifically about your drug and not general disease state questions or those about other companies’ products
  2. Short, consistent safety disclaimers — this would be in lieu of the five thousand pages of fair balance required now
  3. Current prescribing information is your script — don’t add commentary, just include text from your approved labeling
  4. Validate your answer is legitimate — give people a way to confirm that the answer is actually from the company and not an impostor
  5. Catalog and periodically share with FDA — like you have to do with all promotional activities

Some of these precisely included in the guidance and a few didn’t quite make it intact, but overall I think you’ll see the guidance provides for a nice compromise. There is definitely a clear path forward for companies who are looking to correct inaccurate information about their products online and to answer questions posted by consumers (and physicians).

Before going any further, I need to include one important disclaimer: I’m not a lawyer. I’m definitely not your lawyer. So, before you go out and do anything, get the right approvals and don’t come to me later and say it’s my fault should you get in some sort of trouble. Disclaimer over.

The guidance is a bit tough to follow at times, but it does include some very specific and helpful examples to help describe specific situations and what is permitted. What I noticed about the guidance that makes it difficult is that it’s a bit lumped together, when in fact there’s actually a really simple decision tree that can be pulled out of the document. That’s what I’ve done. By simply going through a series of Yes/No questions, you’ll be able to quickly see if you’re allowed to respond to something and how you can respond. So, rather than dissect the document word for word and explain every detail, I think the flow chart I’ve created is more helpful. [Click the image to enlarge it.]

If you find the flow chart useful, then you can download a high-resolution, PDF version (suitable for framing) right here: FDA Guidance Translator Flow Chart (1071 downloads).

So, follow the flow chart and you’ll quickly be able to see where and how it’s appropriate for you to respond to requests. A few important things to consider:

  • Responses should come from medical personnel and not your marketing team. That means that you shouldn’t have your “social media manager” answering questions. I think it’s all right for a non-medical person to flag the requests somehow and then to turn them over to the medical team for a response. This means that you need to get some of your medical staff up-to-speed on social media.
  • This guidance is just that…guidance. These aren’t the final rules. Sometimes the FDA will make guidance it develops into formal rules and other times they won’t. I think it’s safe to say that if you follow the guidance you are in the clear until there is revised guidance or implemented regulations.
  • This guidance applies to unsolicited requests on sites you control and sites controlled by third parties. This means your website, Facebook, Twitter, forums on WebMD…whatever.
  • No where in this document does it say anything about deleting off-label, unsolicited requests when you can. That is, if someone posts an unsolicited request on your Facebook Wall, you could delete it, but this guidance doesn’t require that or even suggest it. In fact, they say that they are concerned about companies posting off-label information in response to requests, which is why they are allowing you only to post contact information to allow individuals to get the information from you directly. I take this to also imply that posting an appropriate response to a request (as outlined in the guidance) is better than simply deleting the original request. This makes sense to me, as it goes to the public health issue. There’s no telling how many people have seen the request by the time the company responds. Deleting it only ensures that no one gets the appropriate information.
  • Read the flow chart and document carefully. It is very clear on the fact that you are not allowed to post full answers that include off-label information in response to requests. The appropriate way is to provide contact information to allow people to get the information from you privately. It’s not ideal, but it is a way forward.
  • There’s one outstanding question I still have. The guidance specifically and exclusively addresses issues about “off-label” (unapproved) information, but doesn’t provide any direction on on-label (approved). For example, if someone asks about the approved dosage for a specific product for an approved use, can a company answer this? It isn’t off-label information. What about if someone asks about the incidence of a certain side effect for a specific drug? Can the company respond with the information directly from the package insert or follow the guidance and respond with contact information? My interpretation is that if this guidance applies to off-label information, then it certainly would apply to on-label information. The FDA has a greater concern about the promotion of off-label use versus on-label use. So, following the guidance precisely for off-label information in cases when the information needed is on-label seems completely reasonable to me.

So, the ball is back in your court pharma. You asked for guidance and now you’ve got some. When you see requests for information about your products online are you going to simply ignore them or are you going to do something about it? I’ve always said that social media for pharma is best used to properly educate people and answer their questions about your products. It’s a chance to communicate with people via social media that have questions about your products and who would really benefit from the accurate information you have versus some of the questionable information they get otherwise. I see it almost as an obligation, but also an opportunity. This is your chance to show that pharma can use social media appropriately and in a way that really does benefit patients. Everyone is expecting you to use it as another way to spam them with drug ads or to trick them into using your products. Prove them wrong by doing this right.

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27 Responses to “Translating the New FDA Social Media Guidance”

  1. David Edelman January 4, 2012 at 1:07 pm #

    Jonathan, thanks for bringing this to our attention and writing a thoughtful review. As a health publisher (http://www.diabetesdaily.com/) it doesn’t answer 90% of my own questions, but it seems like a solid step forward. The standards sound very reasonable to me thus far. 

    • Jonathan Richman January 4, 2012 at 2:08 pm #

      What other questions do you have?

      Don’t expect the FDA to come up with anything for you as a publisher. They only are concerned (and have jurisdiction) over manufacturers. There really aren’t rules you need to follow beyond some FTC rules around disclosure. 

      • David Edelman January 4, 2012 at 2:24 pm #

        I mean that future guidance may one day clarify how pharmaceutical companies are able to work with us. There are questions about when advertisements or sponsorships trigger a need for companies to monitor for and report adverse effects. As a community, this makes it difficult for us to create programs that connect pharma with patients. 

        I fully recognize the potential for abuse in a lot of areas so I appreciate the go slow and be conservative approach when it comes to promotional interactions. 

        I am a confessed optimist, but I see a future where we can find ways for pharmaceutical companies to productively engage with patients. But doing it an a way that prevents abuse…. is much more challenging. 

        • Jonathan Richman January 4, 2012 at 3:08 pm #

          Ah yes…good question. I’m not a person who really believes that all the concern about adverse events is warranted. I think you’d find that on your site there are very few actual adverse events reported, so even if pharma was required to report them, there wouldn’t be many to report. Having said that, I also don’t believe that simply advertising somewhere makes you responsible for the content. If that were the case, there would be a ton of warning letters everyday. In cases where the pharma company controls the content, it might be a different story.

          • David Edelman January 4, 2012 at 3:13 pm #

            I completely agree. If you are required to monitor it, I thought the “if you control it” test would work. If you have financial control (over 50% stake in the entity) or editorial control (can veto the posted content), then you must monitor it. If you don’t have control, then you don’t have to monitor it. There are some edge cases, but I’ve been able to handle them to my own satisfaction with that orientation. 

            • Jonathan Richman January 4, 2012 at 4:34 pm #

              I wouldn’t expect anything specific from the FDA on this topic either. I’m not sure this is even something on their radar.

  2. gene miller January 4, 2012 at 1:31 pm #

    Johnathan, thanks for taking the time for your thoughtful analysis.  I think we are going in the right direction with this guidance from the FDA.

    Just one point.  In your nice flow chart, in the section where everything is public showing how you can respond, item number three seems like it’s out of place: “3. Response must only be given directly and privately to the requestor and not posted publicly”.

    • Jonathan Richman January 4, 2012 at 2:10 pm #

      Thanks, Gene. 

      It’s actually not out of place. You’ll have to look through the full guidance for specifics, but the bottom line is that the FDA doesn’t want companies to post the full answers on sites. They want them to post contact information where individual people can call or email for the answer. Then the company can send it directly and only to the people who requested the information. 

      It makes sense, using their logic, as it prevents companies from posting a ton of off-label information all over the place. It could really be abused by companies who could seek out questions just to publish off-label information.

      • gene miller January 5, 2012 at 9:07 am #

        I agree.  It’s just a little confusing in bullet form on the chart.  If the individual has provided additional contact information, then the response should be direct and private, beyond the general public responses outlined in lines 396-403 of the draft guidance.

  3. Mark Davis January 4, 2012 at 3:14 pm #

    I’ve read this about 5 times and the flow chart is a great device to decipher it. It will be interesting to see how medical affairs handles this load.

    Missing is what the responsibility is of the manufacturer for unsolicited inquires on forums, discussion boards – how much effort should be spent monitoring those. The 3rd party liability question came up in the hearings and is not addressed in this guidance.

    • Jonathan Richman January 4, 2012 at 4:37 pm #

      Good question. The way I see it is that companies have no responsibility to monitor posts or sites that they aren’t already involved in. That is, if they see a request, they don’t have to respond to it. It’s voluntary. However, if they do respond, I think they should follow that thread (and only that thread) to look for additional questions. 

      This is different than the responsibility for adverse events. In that case, if a company sees it on a third party site, they are obligated to act on it. I see no obligation for answering unsolicited inquiries.

  4. Anonymous January 4, 2012 at 3:35 pm #

    Thank you Johnathan, a nice analysis and very useful chart. What I am still trying to work out, perhaps because I am not that familiar with FDA terminology, is whether this is “draft” or “final” guidance. My reading of the document is that it is still a draft and as such seeks comments. Much commentary I have seen is treating this as “The” FDA guidance.  Regards Paul

    • Jonathan Richman January 4, 2012 at 4:39 pm #

      This is draft. If you download the document from the FDA (link in the post), you’ll actually see that it has “Draft — Not for implementation” printed right at the top. True that most (including me) are calling this “The” guidance, but I think it’s only in the sense that it is THE only guidance in this area. This give companies a lot of coverage later if they follow even this draft guidance. They’ll probably (emphasis on probably) not find themselves in violation if no other guidance or regulations supersede this.

      • Anonymous January 4, 2012 at 5:51 pm #

        Interesting. I wouldn’t think that many companies in Europe would follow (from the top of the document) guidance which contains “Nonbinding Recommendations….Not for Implementation”  Most would wait to see what final document contains.

        • Sven Awege January 5, 2012 at 9:24 am #

          Can see where you’re coming from Paul, my view is that the shakers are already there, even in Europe, before this new guidance appeared. The rest are finding excuses.

        • Jonathan Richman January 5, 2012 at 10:01 am #

          A lot of companies have been following guidance of this level for years, which FDA never makes formal. I’m not an expert in this area (and not a lawyer), but to me, following draft guidance is pretty safe in the case where there is absolutely no other guidance or regulations as is the case here.

  5. HouseDoc January 4, 2012 at 4:53 pm #

    The more information there is out there, the greater the need for physician’s advice, to sort out the information and help decide how it applies to individual patients. #HealthCare and #medical advice are always complex subjects. 

  6. Sven Awege January 5, 2012 at 9:22 am #

    Great work Jonathan, I read the guidance document several times, and fully agree that this is a wonderful starting point that Pharma should latch on to. My view is that some Pharma are already ahead of the game, and not waiting. They’re probably keen to keep their lead, and this might be a trigger point for more socially responsible projects.

    • Jonathan Richman January 5, 2012 at 10:02 am #

      This is always the case. Some companies are way ahead of others. I’ve seen very little in the way of companies participating in discussions on third party sites however. Looking forward to seeing this though.

  7. Anonymous January 5, 2012 at 10:25 am #

    Good to see the FDA at least addressing the current paralysis by pharma co’s on social media sites. As you’ve said before there’s potential for harm by not responding at all to or deleting off-label use comments/questions.

    This is going to be tricky for a lot of companies who’ve placed social media squarely in the hands of their PR/Comms/Marketing departments. They’ll have to read the guidance carefully. I agree that even on-label comments are going to need the same response, as you’ve suggested, at least for the time being. “Contact us at X for more information” is the best response for now. There are just too many variables that could cause harm. 

    • Jonathan Richman January 5, 2012 at 10:59 am #

      Yes, that’s probably a safe response for on-label questions as well. We’ll see if any companies get involved now.

  8. Admiral Taptap January 5, 2012 at 10:54 am #

    So the FDA is now advising Big Pharma on how best to restrict off-label info to the most narrow audience possible? Got it.

    • Jonathan Richman January 5, 2012 at 10:58 am #

      An even shorter summary than mine.

      I don’t think this is necessarily a bad thing. The problem is that some companies (or individuals at these companies) are quick to find ways to promote data that they shouldn’t. In most cases, it’s “off-label” for a reason. Inviting companies to freely post this information online would result in more companies taking advantage of the freedom instead of sharing the information responsibly. The FDA really had no choice but to go with this compromise in my opinion.

  9. Felix Jackson January 23, 2012 at 9:02 am #

    Great article. Love the flowchart.

    I think you haven’t mentioned one key point: specifically that the guidance only applies to the off-label use of a medicine that has a different, licensed indication. It does not apply to products in development that do not have a license (I call this pre-licence).

    This could be an important question that is added to your flowchart to make sure that the guidance is applied correctly.

    If you are interested, I have written my own summary and opinion on the guidance on the medDigital blog: http://www.meddigital.com/?page_id=258

  10. Anonymous March 18, 2012 at 1:11 am #

    As a healthcare marketer myself I agree that only medical professionals, and not social media managers, should respond to off-label questions.

    However, this handoff of information–from social media manager to medical professional–is difficult because doctors or pharmacists are already extremely busy and may not view posting in a forum as a productive use of their time.

    Do you have any advice in convincing the medical professionals that responding to these questions is indeed worth their time?

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