[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 (2069 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 (1823 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:
- 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
- Short, consistent safety disclaimers — this would be in lieu of the five thousand pages of fair balance required now
- Current prescribing information is your script — don’t add commentary, just include text from your approved labeling
- Validate your answer is legitimate — give people a way to confirm that the answer is actually from the company and not an impostor
- 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 (1240 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.