Digital Alert and Reco: FDA Warns Novartis Over Facebook Sharing

[UPDATE, Sept. 29, 2010: Our recommendations and guidance have changed since we made this post. Check out this latest post for the update.]

Last week, the FDA issued a Warning Letter for the website for their drug, Tasigna. The main issue in the violation was content that was shared via social media. The Tasigna site had Facebook sharing buttons that, like other sites, automatically generate content for sharing. The content of this content is what the FDA cited. This content is drawn from META description tags on the website. These tags are invisible to visitors, but are used by search engines.

The FDA argues that the content in these META tags should include fair balance (risks, side effects, warnings, etc.) since they had the drug name and indication. The FDA did not have an issue with Facebook sharing in of itself, but rather the content that the site generates automatically, which cannot be changed by the user.

This is a potentially serious issue for all pharma marketers, but one that isn’t as bad as it seems on the surface. Several team members and I here at Bridge Worldwide prepared a response document that details the issues raised in the FDA Warning Letter and also our recommendations on how to deal with the issues FDA brings up in the letter.

You can download a copy of the document here:

(UPDATED: 9/29: Please download our updated recommendations here: Digital Alert-Bridge Worldwide-Social Sharing in Regulated Industries (910 downloads)

We welcome your comments and please feel free to share with your colleagues. As always, if you find it useful, please send out a tweet or Like this post so that others get a chance to see it too.

Some other good commentaries on this issue can be found here:

FDA demonstrates their ignorance of social media with letter to Novartis — Rich Meyer

Digitas Health Facebook Regulatory Alert — Digitas Health

Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget – John Mack

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35 Responses to “Digital Alert and Reco: FDA Warns Novartis Over Facebook Sharing”

  1. Matthew August 9, 2010 at 5:59 pm #

    Unfortunately, while you can play around with the metadescription to make sure it includes the generic but remains a reminder ad (no disease information) that doesn't help with a boxed warning product. These products are not allowed to do reminder ads. So simply the fact that the URL gets posted (http://www.boxedwarningbrandname.com) triggers the need for safety information and a link to the prescribing information and medication guide.

  2. Jonathan Richman August 9, 2010 at 6:17 pm #

    Great observation, Matthew. If we go by the letter of the law here, this would mean that for all boxed warning products, the META description would need to be blank. The question probably is if this counts as a reminder ad. If so, I'd like to see what FDA would recommend be included. So, yes, our recos apply for sure to non-boxed warning products. I'll have to dig a little to see how to apply to boxed warning products. Thanks for bringing this forward.

  3. Jonathan Richman August 9, 2010 at 6:17 pm #

    Great observation, Matthew. If we go by the letter of the law here, this would mean that for all boxed warning products, the META description would need to be blank. The question probably is if this counts as a reminder ad. If so, I'd like to see what FDA would recommend be included. So, yes, our recos apply for sure to non-boxed warning products. I'll have to dig a little to see how to apply to boxed warning products. Thanks for bringing this forward.

  4. Zane Safrit August 9, 2010 at 9:00 pm #

    You’re in an interesting spot. You want to design your client’s pages to maximize search results and word-of-mouth. You want to create a message about your client’s products that encourages their audience to further share it…implying an endorsement or at least a ‘look at this…’ recommendation.

    On the other hand, the client’s products have sometimes dangerous side-effects by themselves or when used with other products or when used incorrectly. And those side-effects are life threatening.

    And when those word-of-mouth recommendations move farther away from the source, the company’s materials, then the risk of those side-effects only grows.

    Isn’t it risky to move towards a more more general message that
    does not require fair balance, but is still useful to search engines and users. Isn’t it useful for users to understand those risks? Yes, it’s useful for users to see that Tasigna can be used to treat certain patients with a type of leukemia. But wouldn’t it be useful for those same users to see in that same spot that Tasigna should not be used if the user is allergic to nilotinib, or if you have low blood levels of potassium or magnesium, or a history of “Long QT syndrome.”

    There are many other drugs that can cause serious or life-threatening medical problems if you take them together with Tasigna.

    You should not use Tasigna if you are allergic to nilotinib, or if you have:
    • low blood levels of potassium or magnesium; or
    • a history of “Long QT syndrome.”
    If you have any of these other conditions, your doctor may need to adjust the dose of Tasigna or order special tests:
    • heart disease or heart rhythm disorder;
    • liver disease;
    • a personal history of pancreatitis; or
    • a family history of “Long QT syndrome.”
    FDA pregnancy category D. Do not use Tasigna if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether nilotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Tasigna.
    See also: Pregnancy and breastfeeding warnings in more detail
    Tasigna capsules may contain lactose. Talk to your doctor before using Tasigna if you have galactose intolerance, or severe problems with lactose (milk sugar).

    Read more: http://www.drugs.com/tasigna.html#ixzz0w91jjy1V

    Or that patients have reported:

    abdominal discomfort, acidosis, acute lymphocytic leukaemia recurrent, blood creatinine increased, blood urea increased, cardiac failure congestive, central nervous system leukaemia, dehydration, dilatation ventricular.

    http://www.patientsville.com/medication/tasigna

    Would that be useful for users to also see?

    It’s the users health that’s at risk as well as the returns on investment for the pharma company and its marketers.

  5. Chris Nelson August 10, 2010 at 12:30 am #

    Hi Jon. Great to see everyone discussing and learning about what the best approach might be.

    I have a somewhat differing opinion/suggestion…

    Yes, this (more officially) brings social media “up to standards” with what must be done re: compliance. But, I'm not sure a generic meta description is the best approach. (In fact meta may be getting a bad rap here.)

    Sure, meta that is off label or inaccurate – for it's intended function (description of the page of content it's created for) – should definitely be fixed. But, honestly that goes for any content on the page text/video/image or otherwise. These are all things within our control.

    But, changing title/meta to generic, non-descriptive statements is not ideal as it will likely have a negative impact on search and general usability.

    What is also within our realm of control is the ability to change what info/content we send to FB and Twitter when a social share occurs. (See FB open graph for an example.)

    One of the problems with Novartis was that they employed a tool that chose a default approach of sending title/meta. This tool also appeared to “truncate” the description – not good when your indication is lengthy.

    So, understanding all of this – as digital marketers and content developers – why not take the best of both worlds: 1) leave meta to do what it was designed for (description of a web page), and 2) develop FDA compliant copy for social shares.

    Sure, it may take a little extra work – but with the right partners and technology it shouldn't be moving mountains. And, we all know it will be worth the effort!

  6. Chris Nelson August 10, 2010 at 12:30 am #

    Hi Jon. Great to see everyone discussing and learning about what the best approach might be.

    I have a somewhat differing opinion/suggestion…

    Yes, this (more officially) brings social media “up to standards” with what must be done re: compliance. But, I'm not sure a generic meta description is the best approach. (In fact meta may be getting a bad rap here.)

    Sure, meta that is off label or inaccurate – for it's intended function (description of the page of content it's created for) – should definitely be fixed. But, honestly that goes for any content on the page text/video/image or otherwise. These are all things within our control.

    But, changing title/meta to generic, non-descriptive statements is not ideal as it will likely have a negative impact on search and general usability.

    What is also within our realm of control is the ability to change what info/content we send to FB and Twitter when a social share occurs. (See FB open graph for an example.)

    One of the problems with Novartis was that they employed a tool that chose a default approach of sending title/meta. This tool also appeared to “truncate” the description – not good when your indication is lengthy.

    So, understanding all of this – as digital marketers and content developers – why not take the best of both worlds: 1) leave meta to do what it was designed for (description of a web page), and 2) develop FDA compliant copy for social shares.

    Sure, it may take a little extra work – but with the right partners and technology it shouldn't be moving mountains. And, we all know it will be worth the effort!

  7. Chris Nelson August 10, 2010 at 12:30 am #

    Hi Jon. Great to see everyone discussing and learning about what the best approach might be.

    I have a somewhat differing opinion/suggestion…

    Yes, this (more officially) brings social media “up to standards” with what must be done re: compliance. But, I'm not sure a generic meta description is the best approach. (In fact meta may be getting a bad rap here.)

    Sure, meta that is off label or inaccurate – for it's intended function (description of the page of content it's created for) – should definitely be fixed. But, honestly that goes for any content on the page text/video/image or otherwise. These are all things within our control.

    But, changing title/meta to generic, non-descriptive statements is not ideal as it will likely have a negative impact on search and general usability.

    What is also within our realm of control is the ability to change what info/content we send to FB and Twitter when a social share occurs. (See FB open graph for an example.)

    One of the problems with Novartis was that they employed a tool that chose a default approach of sending title/meta. This tool also appeared to “truncate” the description – not good when your indication is lengthy.

    So, understanding all of this – as digital marketers and content developers – why not take the best of both worlds: 1) leave meta to do what it was designed for (description of a web page), and 2) develop FDA compliant copy for social shares.

    Sure, it may take a little extra work – but with the right partners and technology it shouldn't be moving mountains. And, we all know it will be worth the effort!

  8. Chris Nelson August 10, 2010 at 12:30 am #

    Hi Jon. Great to see everyone discussing and learning about what the best approach might be.

    I have a somewhat differing opinion/suggestion…

    Yes, this (more officially) brings social media “up to standards” with what must be done re: compliance. But, I'm not sure a generic meta description is the best approach. (In fact meta may be getting a bad rap here.)

    Sure, meta that is off label or inaccurate – for it's intended function (description of the page of content it's created for) – should definitely be fixed. But, honestly that goes for any content on the page text/video/image or otherwise. These are all things within our control.

    But, changing title/meta to generic, non-descriptive statements is not ideal as it will likely have a negative impact on search and general usability.

    What is also within our realm of control is the ability to change what info/content we send to FB and Twitter when a social share occurs. (See FB open graph for an example.)

    One of the problems with Novartis was that they employed a tool that chose a default approach of sending title/meta. This tool also appeared to “truncate” the description – not good when your indication is lengthy.

    So, understanding all of this – as digital marketers and content developers – why not take the best of both worlds: 1) leave meta to do what it was designed for (description of a web page), and 2) develop FDA compliant copy for social shares.

    Sure, it may take a little extra work – but with the right partners and technology it shouldn't be moving mountains. And, we all know it will be worth the effort!

  9. Chris Nelson August 10, 2010 at 12:30 am #

    Hi Jon. Great to see everyone discussing and learning about what the best approach might be.

    I have a somewhat differing opinion/suggestion…

    Yes, this (more officially) brings social media “up to standards” with what must be done re: compliance. But, I'm not sure a generic meta description is the best approach. (In fact meta may be getting a bad rap here.)

    Sure, meta that is off label or inaccurate – for it's intended function (description of the page of content it's created for) – should definitely be fixed. But, honestly that goes for any content on the page text/video/image or otherwise. These are all things within our control.

    But, changing title/meta to generic, non-descriptive statements is not ideal as it will likely have a negative impact on search and general usability.

    What is also within our realm of control is the ability to change what info/content we send to FB and Twitter when a social share occurs. (See FB open graph for an example.)

    One of the problems with Novartis was that they employed a tool that chose a default approach of sending title/meta. This tool also appeared to “truncate” the description – not good when your indication is lengthy.

    So, understanding all of this – as digital marketers and content developers – why not take the best of both worlds: 1) leave meta to do what it was designed for (description of a web page), and 2) develop FDA compliant copy for social shares.

    Sure, it may take a little extra work – but with the right partners and technology it shouldn't be moving mountains. And, we all know it will be worth the effort!

  10. Chris Nelson August 10, 2010 at 12:30 am #

    Hi Jon. Great to see everyone discussing and learning about what the best approach might be.

    I have a somewhat differing opinion/suggestion…

    Yes, this (more officially) brings social media “up to standards” with what must be done re: compliance. But, I'm not sure a generic meta description is the best approach. (In fact meta may be getting a bad rap here.)

    Sure, meta that is off label or inaccurate – for it's intended function (description of the page of content it's created for) – should definitely be fixed. But, honestly that goes for any content on the page text/video/image or otherwise. These are all things within our control.

    But, changing title/meta to generic, non-descriptive statements is not ideal as it will likely have a negative impact on search and general usability.

    What is also within our realm of control is the ability to change what info/content we send to FB and Twitter when a social share occurs. (See FB open graph for an example.)

    One of the problems with Novartis was that they employed a tool that chose a default approach of sending title/meta. This tool also appeared to “truncate” the description – not good when your indication is lengthy.

    So, understanding all of this – as digital marketers and content developers – why not take the best of both worlds: 1) leave meta to do what it was designed for (description of a web page), and 2) develop FDA compliant copy for social shares.

    Sure, it may take a little extra work – but with the right partners and technology it shouldn't be moving mountains. And, we all know it will be worth the effort!

  11. Jonathan Richman August 10, 2010 at 2:21 am #

    The problem with this approach is that it's not technically possible based on this new regulatory guidance. Either you can have completely meaningless META descriptions (Ask your doctor if Drug X is right for you) or no META descriptions. If you include the slightest suggestion of what the drug does, then you need all the fair balance. However, you can't add the fair balance in the META tags. So, the best compromise to me is having META descriptions that are compliant, but that also encourage people to click on the shared item and find out more. Let's be clear: no one is going to ask for and start taking a drug based on the quick description of a page shown on a friend's Facebook page. That idea is crazy. The person is going to do some research and in the course of that research will see all the good and all the bad.

    So, yes, it would be useful for people to see all of this, which is why the website exists. Social sharing is supposed to encourage people to visit the site in shared, not make decisions based on the snippet that is shared. This is especially true in healthcare. The question is this: is it better to have META descriptions that when shared tell you nothing about the drug and give someone no reason to click on the shared content (to read the whole thing) and find out more OR is it better to share just a little to pique someone's interest so that they click to get the full story. I'd argue that the latter is the best option for everyone.

  12. Jonathan Richman August 10, 2010 at 2:40 am #

    Chris,

    Good suggestion and actually one that we investigated and included in our full recommendation (check out the link for the PDF to download in the post above). Yes, you can have different META data for Facebook sharing and for what is seen and used by search engines in search results pages. However, what about ShareThis, which the Novartis page also used? You can't specify different META descriptions for each social media platform, so what happens when I use ShareThis to share on Digg, Google Buzz, MySpace, Orkut, LinkedIn, or Mixx. What if I snip a bit of it to autopost to my Posterous blog or Amplify? Or what about any of the other 25 sharing options in Shareaholic? Are you going to have different META descriptions for each of these? Problem is that you can't. There's no technical (never mind practical) way to do this.

    Based on the letter, as I see it, sharing via Facebook isn't the issue. The auto-generated content that is written by the site owner that becomes the shared content is the issue. This shared content is based on META descriptions, which are completely controlled by the company who developed the site.

    So, while having more generic (but not completely generic) descriptions isn't ideal, it is the best solution. The FDA has yet to cite someone based on how their website's content appears in search results, but that is coming. It's clearly warned about in this letter. Generic descriptions will not affect search rankings, as META descriptions are not a factor for search rankings for any of the major search engines. They could affect clickthrough rates on search results, so this is why we explain in our full recommendations that companies write the descriptions so that they are somewhat compelling instead of overly generic like “Find out if Drug X is right for you.”

    Just a quick technical note, the tool they employed isn't a Novartis based tool, it was simply a shortcut Facebook share button that works one way and one way only. When you share something using the widget, it grabs content based on who Facebook created the coding (which isn't used any longer since Open Graph was introduced). At the same time, the tool, nor any setting that Novartis could control (since there aren't any in the old sharing tools) the length of the description. This is set by Facebook at around 50 words. Everything else is truncated using these social sharing tools. So, Novartis couldn't control any of this outside of changing the content that is shared by changing the META descriptions. This was all considered and covered in our full document, as we did have some consultation with Facebook.

    However, to be sure, the issue here isn't Facebook or any other type of social sharing. If it was, FDA would have also showed a bunch of user added comments and how these could make the shared content even more of a violation. The issue is in what is shared and the fact that the manufacturer sets these parameters. Since they control them and own them, then they must be compliant. They weren't. In fact, based on this standard, I'd argue that almost every single pharma brand website would be in violation, which is why you can expect to see more letters soon. Perhaps FDA took more issue with Novartis' because they “enabled” the sharing a bit more by having the widget on the page, but I don't think that's the standard. I have 3 extensions in Chrome that allow me to share with 40 different social networks regardless of what tools the site provides me. If I used any of the 40, this site still would be out of compliance based on the standards in the letter.

    So, while I appreciate the comment and solution (it was an early one that we thought might work as well), it doesn't address the underlying issues raised by the letter. Regardless of what the bigger picture is that FDA is trying to communicate, this idea doesn't work since FDA called out ShareThis as an issue since it uses the same META data. You can't customize the META data for ShareThis nor the individual social sites that you can share to from it (except for Facebook). So, according to FDA, ShareThis is an issue and the solution you mentioned doesn't solve for this.

  13. BioJobBlogger August 10, 2010 at 3:33 pm #

    While I tend to agree with what you say most of the time, I have to differ with your take on the Novartis Facebook brouhaha. The people who design websites and widgets for pharmaceutical companies know about metatags and how to configure the code to optimize search engines. Alternatively, the widgets can be configured to add code that will display appropriate safety information or direct folks to it.

    This is just another example of pharmaceutical marketers trying to goose the system knowing full well what the implications of their actions may be. All drugs have side effects and the label defines appropriate use of an approved drug. If the manufacturers are not forthcoming with the required safety information and guidelines for use then those companies are at risk of possible regulatory actions and lawsuits. Cmon, everybody knows the rules of the game…if everybody would play fair and according to the rules (that they all know and understand) we would have fewer warning letters and social media would have easily been adopted by pharma just like all other industries doing business today.

  14. Matthew August 10, 2010 at 12:43 pm #

    I think the key point around sharing is who initiates the concept of sharing. If I have a Share To Facebook widge on my toolbar (which I do), and and a private citizen, I choose to share a page, that's my business. I'm under no obligation to provide safety information or a link to prescribing information. But, if as a Webmaster for a Pharma company I place a Share This button on the site itself, that's completely different. Now the company is initiating the share, so that share has to be compliant to all promotion laws.

    Now, whether or not FDA is doing more harm than good by treating social media that way is another question entirely.

  15. Matthew August 10, 2010 at 12:45 pm #

    Furthermore, the URL would need to be unbranded, or the drug name in the URL would trigger everything else.

    So, does that mean that the main URL for boxed warning drug (and maybe even all drugs to be safe) should be unbranded with brand.com redirecting to it?

  16. Matthew August 10, 2010 at 12:47 pm #

    How long before DDMAC extends this philosophy to organic search results? The Pharma company controls the meta description, so they can be held responsible for it, regardless of its intentions.

    They already issued letters on sponsored search, which granted is clearly advertising as you pay for clicks, but the look/feel to the user is almost identical, so how long . . . ?

  17. Tdeal August 10, 2010 at 2:14 pm #

    Great post, Jonathan (as usual)! When I initially read the news on this, I thought it was doomsday, but your analysis and recommendation around META tags and the new “like” buttons make perfect sense. I still don't think it's great news because perception is reality and things like this will scare busy brand managers away from FB and social media, particularly if they don't dive deeper into the story than just the headline. But thankfully there are people like you out there to help us all better understand what's really going on and what it means to our business. Keep up the great work!

  18. Jonathan Richman August 10, 2010 at 3:36 pm #

    A finer point, but this isn't quite the issue. Yes, as a private citizen, you can say whatever you want about anything (sort of) and share it however you want. You have no legal obligation to provide fair balance like a manufacturer. However, if the content you are sharing is generated by a pharma company and that content isn't compliant, then the company is liable.

    The offline equivalent would be if the company gave you a print brochure about one of their drugs so you could give it to a friend, but the brochure had no fair balance. You wouldn't be under any obligation to give fair balance, but the FDA would have something to say about the brochure, since the company created it. In this case, the META data is the brochure and the way you're sharing is by hand. Inherently, there's no real difference as the FDA sees it.

  19. Jonathan Richman August 10, 2010 at 3:38 pm #

    Not very. I mentioned this in my full recos and to a few other people who asked. It's the same exact content that was cited in this letter placed somewhere without fair balance (search results page), so it's the same thing. Paid search was simpler to go after because the companies wrote the copy and intended to have it displayed exactly that way. There might be a bit more leeway for META data since it's largely invisible and companies might argue there was no intent to create something misleading.

    Stay tuned…I think this is the next big thing.

  20. Jonathan Richman August 10, 2010 at 3:40 pm #

    Thanks. Yes, I agree that it's going to take a little more work now, but everything should be fine. On the plus side, you can point out to people that FDA didn't express any concern for comments that people added to the content from the META tags. That is, it doesn't appear that FDA thinks companies are liable for comments or additional content that is either created by consumers or used to further enhance companies' content. This should put companies at ease who were somehow worried that they'd be responsible for anything said about their drug no matter where it was posted.

  21. Jonathan Richman August 10, 2010 at 5:08 pm #

    I disagree with this for a couple of reasons. Yes, the people who make these sites know about meta data, but likely the Pharma clients don't. It's not an excuse, but is the reality.

    The meta descriptions have no impact on search results rankings. They do appear in search results, but only to provide a bit more clarity about what the subject of the page is. There's not much space to use though, so you can't say much.

    From a technology standpoint, you cannot configure what each of these sharing tools shows. You can set what Facebook shows, but that's about it. What about the 25 or so other top sharing sites? You can't set what is displayed for all of these on a case by case basis without changing the meta data. So, every share (with the exception of Facebook) would share the same content. The sharing tools aren't as customizable as you imply. Assuming you could make one that was to put on your site, this still doesn't fix the problem, which is the content in the meta data. I believe companies are equally liable if the sharing widget was embedded in their site or the visitor used a sharing tool that's part of their browser.

  22. Nathan Stewart August 10, 2010 at 5:50 pm #

    Meta Tags, when used by the search engines to insert a title and description, do not provide “a bit more clarity” but the ONLY clarity a user will receive about the site before going to it from search. Is it worth it for major pharmaceutical companies to diminish their ability to participate in a “pull” marketing channel, and channel where around 91% of all internet users begin their internet experience, a marketing channel filled with highly relevant traffic, so that someone can post to their Facebook page about a drug that may be only relevant to them.

    In the future, maybe. In the present, I don’t believe so.

    I can say with strong confidence that Novartis has received more traffic from natural search then they have received from all social sites combined. Do we even know how many users actually used the “Share” feature?

    • Jonathan Richman August 10, 2010 at 11:09 pm #

      Here’s the thing, Nathan. This might not a choice that companies have. They may not be able to have meta descriptions like they always have had. The FDA appears to be saying that the content within those meta descriptions are a problem. So, they may not have a choice. They may have to change them to remain in regulatory compliance. I don’t think the issue is only social sharing, it’s the content that is shared, which is generated by pharma companies and isn’t compliant with DDMAC regulations as is (in most cases).

      I totally agree that I’d rather have quality descriptions for search than for social sharing. And I’d rather have organic search traffic versus social media traffic if I’m a pharma company since the former is much larger now, but perhaps not for long. I don’t think you’re making a choice between one or the other. Companies have to interpret the FDA letter for themselves to determine if they believe the issue is the meta descriptions wherever they appear or the social sharing aspect.

      Just a finer point, the meta description isn’t the only thing that gives clarity. The page title should be fairly descriptive as well (and actually impacts search rankings unlike meta descriptions). That’s why I said “some clarity.”

  23. Chris Nelson August 10, 2010 at 6:06 pm #

    Hi John. Thanks for the quick reply.

    After reading all the replies and responses from last night and this am, to me the issue that caused the letter can (still) be boiled down to:

    The pharma company initiated/encouraged the social share by placing the tool “ShareThis” on the site, and what was shared was not compliant. (As you explained, this tool was built for non-pharma sites, and has no ability to control what it sends to social networks.)

    I am giving the FDA the benefit of the doubt here. They understand that tools you place on your site are within your control. (Even if the only “control” you have over that tool is to place the tool on the site or remove it.)

    So, to elaborate on my suggestion: I suggest removing non-compliant tools and look for other alternatives. (They exist, or you can build your own internal tool.)

    Additionally, you cannot promote social networks that you cannot control. (Many of the ones you mentioned as examples.)

    In my opinion, this is still the ideal approach. You do not want to negatively affect a channel (search) that is one of the highest volume and quality traffic drivers.

    Here's my example tying it to offline promotion. Company X creates a brochure. Company X then hands the brochure over to a 3rd party for distribution. The 3rd party cuts out one paragraph, and then passes it over to consumers. These consumers then hand out the (non-compliant) paragraph to others.
    Company X may not be able to control what the 3rd party is cutting down in the brochure, but they can control if they work with that 3rd party!

    I don't think (hope) organic search comes up anytime soon. To use another offline example – it would be the equivalent of releasing an FDA compliant press release to the public, and then the pharma being held responsible for how Channel X news delivers the message on their nightly TV show. These are things completely out of our control – in the same way we cannot control Google’s natural search results. Paid search was called out because that is entirely within our control. (It's ad copy the pharma develops.)

    Great conversation. Keep it going!

  24. Jonathan Richman August 10, 2010 at 6:56 pm #

    Makes sense, Chris. The question really is whether the issue that bothered FDA was that on this site the sharing was encouraged (or you might say enabled) by the company, so they knew what was going to happen and what content was going to be shared and they made sure this happened. Or you can argue that it doesn't matter if the tools were available on the site, it's the content shared by the that creates the issue.

    I'm not sure which I'm hoping is correct. Each would pose different problems actually. The first scenario (your idea) would be simple to manage by leaving out sharing tools or customizing them for your site and the content. Not a huge deal, but still doable. The question would be whether or not people would embrace these special pharma sharing tools (and trust them) opposite the standard tools they're used to. I'd guess that they wouldn't. Alternatively, the second scenario still allows you to have the standard sharing tools on your site, but you'd have to water down your meta descriptions, which makes the content being shared a little less powerful. However, you would be able to use the standard sharing tools that people are used to using and I'd bet the rate of sharing would be much higher.

    I think I'm leaning to the second scenario.

    I am trying to get a better answer on this from several people regarding what the actual issue is, so stay tuned. Thanks for keeping the discussion going.

  25. Jonathan Richman August 11, 2010 at 3:09 am #

    Here’s the thing, Nathan. This might not a choice that companies have. They may not be able to have meta descriptions like they always have had. The FDA appears to be saying that the content within those meta descriptions are a problem. So, they may not have a choice. They may have to change them to remain in regulatory compliance. I don’t think the issue is only social sharing, it’s the content that is shared, which is generated by pharma companies and isn’t compliant with DDMAC regulations as is (in most cases).

    I totally agree that I’d rather have quality descriptions for search than for social sharing. And I’d rather have organic search traffic versus social media traffic if I’m a pharma company since the former is much larger now, but perhaps not for long. I don’t think you’re making a choice between one or the other. Companies have to interpret the FDA letter for themselves to determine if they believe the issue is the meta descriptions wherever they appear or the social sharing aspect.

    Just a finer point, the meta description isn’t the only thing that gives clarity. The page title should be fairly descriptive as well (and actually impacts search rankings unlike meta descriptions). That’s why I said “some clarity.”

  26. Jonathan Richman August 11, 2010 at 3:18 am #

    Here's the thing, Nathan. This might not a choice that companies have. They may not be able to have meta descriptions like they always have had. The FDA appears to be saying that the content within those meta descriptions are a problem. So, they may not have a choice. They may have to change them to remain in regulatory compliance. I don't think the issue is only social sharing, it's the content that is shared, which is generated by pharma companies and isn't compliant with DDMAC regulations as is (in most cases).

    I totally agree that I'd rather have quality descriptions for search than for social sharing. And I'd rather have organic search traffic versus social media traffic if I'm a pharma company since the former is much larger now, but perhaps not for long. I don't think you're making a choice between one or the other. Companies have to interpret the FDA letter for themselves to determine if they believe the issue is the meta descriptions wherever they appear or the social sharing aspect.

    Just a finer point, the meta description isn't the only thing that gives clarity. The page title should be fairly descriptive as well (and actually impacts search rankings unlike meta descriptions). That's why I said “some clarity.”

  27. Nathan Stewart August 11, 2010 at 4:43 pm #

    Thanks for the reply, Jonathan.

    It sounds like we have reached an impasse due to differences in interpretation, just like anyone who has read the Bible, studied philosophy, or seen the move 'Contact'. We seem to be taking different things away from this FDA letter.

    From reading your above article and comments, I think we do agree that current Meta Tags are not the best source to draw on for sharing tools, and that the Novartis Meta Tags had some issues in and of themselves.

    Where we don't seem to agree, with regard to this most recent FDA letter, is whether this is the fault of the Meta Tags or the Sharing Tools.

    My point is simply that by changing Meta Tags to meet the needs of a sharing tool is a perversion of what Meta Tags are meant to do, and has major implications for SEO and users finding the valuable information they need. Considering that Meta Tags are addressed in this FDA letter only within the realms of Social Sharing Tools, I believe that changing Meta Data to be either generic (which won't tell anyone anything about the content of the page or help with search rankings) or to include ISI (something that no one would see anyway considering the limited space on search engine results) seems to be an extreme and ineffective response.

    In other words, just take down the sharing tool, or add one that allows for greater customization beyond pulling from Meta Tags.

    I acknowledge your point that Meta Tags might one day fall under the gaze of the FDA, but I don't believe that day is today. And if that day does come, I will not go quietly into that good night, but will claw, kick and scream for better FDA education regarding the purpose and level of user interaction of Meta Data.

    But hey, I'm a search guy. It's my job to freak out about this stuff. I am curious to see how this plays out.

  28. Jonathan Richman August 11, 2010 at 6:02 pm #

    Glad someone freaks out about this stuff.

    Perhaps this is a bit of a perversion of meta descriptions, but what else are they used for? As you know, they have no impact on search rankings. The only impact they have would be on what is shown on SERPs next to each link. However, I think between a quality page title (never a given) and a meta description that tells you something, you shouldn't lose any clickthrough. When I say “generic” I don't mean “try drug x”. I mean something that actually describes what the page is about. Considering that the content FDA objected to was consisted only of the drug indication, I'd say these weren't effective descriptions anyway. They should describe what's on the page, not be the same on every page. So having something like “drug x is used to treat a variety of conditions, which are described on this page” is way better than most meta descriptions already and it's regulatory compliant. Check out some of the meta descriptions on pharma sites, they aren't great and most have the same description on every page. That's got to really freak you out.

    So, in my mind, we can improve descriptions by making them, well, descriptive finally and at the same time be compliant with the regulations.

  29. BioJobBlogger August 13, 2010 at 1:27 pm #

    After working with professionals who design and operate websites, I believe that any technological issues can be overcome by clever and creative software engineers. My bottom line: pharma marketers and brand managers know they are going to get whacked by FDA if appropriate safety information is not supplied with promotional ads whether print, radio or web-based. Instead of trying to test the water and limits in areas where regulatory guidelines may be murky or don’t exist, there may be a better ROI and uptick in sales if ads making use of social media are crafted based on accepted and well known regulations. A great example of this is Novo Nordisk’s Race for the Cure diabetes medication promotion on Twitter. The campaign was brilliantly crafted (based on existing regulatory guidelines) and has been extremely successful (without regulatory agency intervention) on Twitter one of the cutting edge social media tools. Perhaps other companies like Novartis can implement similar campaigns without running afoul of FDA and other regulatory agencies.

    My rule of thumb is: if the guidelines are difficult to interpret or don’t exist the best thing to do is contact the agency and ask what they think may be acceptable or not. The days of playing cat and mouse with the agency make about as much business sense as the antiquated blockbuster drug business model.

  30. Jonathan Richman August 13, 2010 at 1:38 pm #

    I’m in agreement. I don’t see a lot of benefit pushing the limits because you don’t think they’re clear. That’s not going to work as a defense at least. I think there’s enough evidence and examples out there that show companies that pushing too far and excluding risk information, promoting off-label, etc. may work in the short-term, but in the long-term you’re going to get caught and punished in a big way.

  31. Kmm Murdock August 13, 2010 at 3:52 pm #

    Why not create your own share this functionality that includes ISI and link to PI to balance title and url of webpage shared?

  32. Jonathan Richman August 13, 2010 at 4:01 pm #

    That doesn’t quite solve the problem that you’re limited to the length of content that you can share. For example, even if your sharing tool has all the right info, if you post on Facebook, Facebook will trim it down to the first 45 or so words. You can’t get all the ISI in there. Having a link is not a solution. FDA has been pretty clear that a link to safety information isn’t good enough. Since you can’t fit everything in the space allowed and you can’t link to the rest, there’s still a problem.

    In addition, I’m not sure that people will trust or know what do with a pharma created sharing tool. It goes against everything else they do online.

  33. Matthew August 16, 2010 at 3:11 pm #

    I don’t know about that Jonathan. The pharma company put out a compliant Web site. In your example, the company was violating the law by sharing a noncompliant brochure with me in the first place. The comparison would be a compliant brochure being given to me, me making a photocopy of the opening paragraph, and then posting that photocopy in a public place with a note to get a copy of the full brochure.

    That’s not the company’s fault.

    However, adding a Share This function to a Web site is akin to perforating that first page and printing “Pull this out and share it with your friends.” By instructing the user to separate the claims and ISI the company has put themselves at risk.

    Of course, the argument could be made that the company knows that the metadata will appear if someone shares the site regardless of whether or not they asked the user to share the site, but does that put the company at risk?

    We all know that the metadata is often pulled by search engines and appears devoid of ISI and PI link on Yahoo!, Google, and Bing, but no letters have gone out on that . . . yet. One would think that the Novartis letter easily could have had a paragraph about that, or the Sponsored Link letters that went out to most of the major pharmaceuticals last year could easily have mentioned organic search.

  34. Jonathan Richman August 16, 2010 at 4:12 pm #

    Good (I should say, better) analogy about the “perforated” brochure. I’m with you. Perhaps I overstated my point a bit. Let’s look at it this way. The question is really this: did the company actually put out a compliant website? If you argue that the company had no idea how meta data is used and never intended for it to be used elsewhere (with or without their permission), then maybe you can say that they’re clear. If you know that the meta description is used by Google and others and that this description is clearly violative as is, don’t you have an obligation to change it?

    The answer is that I don’t know. Maybe yes, maybe no. The question becomes, to borrow your analogy, is having meta descriptions that are violative on their own the equivalent of having a perforated brochure? I’m not sure whether or not enabling the sharing (in this case by having the widget on your site) makes it better or worse. Only the FDA knows for sure.

    Regarding your last point, no letters have gone out yet, with that last word being the key. I’m not sure FDA would include information about how search engines use the data it in this letter. They’re talking about one particular piece of a website while how search engines use it is another (but related) issue. I think they try to keep these letters pretty focused. Same would go for the Sponsored Link letters if you go by this logic. I’m working more on getting a definitive answer on some of these.