Archive | regulatory RSS for this section

Are Meta Tags a Regulatory Time Bomb?

Your branded pharma site is non-compliant. Yes, yours.

Paying attention yet?

As pharma marketers, we operate in a world governed by strict rules. As digital pharma marketers, those strict rules can often be ambiguous, poorly-defined, or simply absent, requiring us to interpret vague requirements and/or extrapolate from other (presumably) relevant precedents. (Yeah, I know, it’s almost exactly like having a girlfriend.)

Which brings me back to your Brand.com.

What’s to worry about, you say? Everything’s ship-shape, buttoned-up, right? On-label messaging, appropriate fair balance, all content submitted and approved by the FDA. Looks like everyone else’s.

Well, perhaps there is one aspect of your branded product site that you’ve overlooked. One that is routinely ignored as it seems so tucked away and safe from scrutiny. But one that is on the FDA’s radar and which might be the source of some serious compliance headaches one day soon. Could it be that deep down within the HTML code of your website there exists a regulatory time bomb?

Read More…

Applying Some Sanity to a Regulatory Debate

Okay…today’s post is a bit of a rant, but I think it’ll include some practical, rationale advice that will help you too. As you can tell by the featured image for this post, I find myself out of ideas on how to explain my point in a calm, bullet-pointed way, so I’m going with the rant approach. I’d like to thank a number of you for both adding clarity to my thoughts and for being the very inspiration behind this post (you each know who you are).

What am I so annoyed at?

Conservatism.

Not the political ideology…the approach to marketing and specifically legal and regulatory concerns. To be sure, I’ve been one of the biggest defenders of the legal and regulatory teams at various companies. It’s not an easy job. You’ve got people like me telling you that you’re crazy and bashing their skulls against your walls when you won’t let them do something we we’d like. But at the same time, you save us from ourselves sometimes. As one of my favorite regulatory people once said, “I’m not telling you that you can’t do it, DDMAC [i.e., the FDA] is telling you that you can’t do it.” Substitute your own industry’s watchdog group in that quote if you’d like.

That somehow managed to get me off the ledge a few times and made me redirect my ire to more appropriate targets. However, after working with many, many companies over the past couple of years, I’ve realized one thing: it isn’t always DDMAC after all. Certainly it is sometimes, but other times, perhaps more times, it’s us. We’re not really mad that the FDA is preventing us from doing something, we’re mad that our own company won’t. Again, many of these rules exist to protect the company and make a lot of sense. I get that and I’m not advocating for anarchy, but I am advocating for a bit of common sense (perhaps I should have used a picture of Thomas Paine’s essay instead of the Sanity picture…nah).

The one “rule” that is making me crazy lately deals with the concept and interpretation of “sponsorship.” Allow me to explain what I mean by this. This might be something like when a company pays to have their content included on a website in something like a special information section. WebMD has a number of these. The regulatory challenge is that since the company is paying for the placement of this content, even though they don’t control the site in any other way (e.g., WebMD), the company is, of course, still responsible for the content itself. That is, they can’t include wildly off-label or inaccurate information simply because it’s not on their own website (here’s an example of one of these pages). Got that…makes total sense.

Here’s where I get annoyed…someone along the way has taken this regulation WAY too far. It seems that everything is treated as a “sponsorship” and what is in the control of the company and what it is liable for has been absurdly expanded. It’s no longer just sponsored “sections” or pages, it’s now ads as well. Allow me to demonstrate.

Rather than have a sponsored section on WebMD, you place a banner ad on WebMD. Okay. No problem, right? Wrong.

The new regulatory concern these days is figuring out what page the ad is placed on and what content surrounds it. Similarly, for the sponsored page, what other content, but that is not controlled by the company, is included on the page? The rationale?

Here’s an almost direct quote that I heard last week: “If we placed and paid to have something on the site, then we’re responsible for whatever is around it even if we have no control whatsoever over what’s around it.”

Seriously?

I’ve heard this from five different companies in the past two weeks. It’s a trend.

It’s leading to some behavior I find odd and unnecessary. For example, one company has removed their Facebook page because they were concerned about the ads (that Facebook controls) being placed next to their page’s content. What? The rationale from the legal and regulatory teams is that the company is somehow responsible for the content of those ads and the ads could expand the product’s claims and….

I don’t know what came after that…my ears stopped working, but I think you can fill in the blanks. I understand not wanting to have your ad next to an article bashing your product. That’s another story. That’s not desirable certainly, but it’s also not a violation of any laws.

So, let’s look at this rationally. First, this phenomenon appears to be especially acute on any site that you could remotely categorize as “social media.” That is, the rules seem a bit more lax when we’re not talking about Facebook. Social media always seems to make people panic. This tends to create a few interesting double standards. We’ll come back to that in a minute.

First, I want to share a perfect analogy that explains why all of this is so crazy. It comes from Peter Pitts, a former Associate Commissioner at the FDA and current partner at PR firm, Porter Novelli. I’d encourage you to read his entire commentary found in this white paper, but here’s the part I loved:

“…what does “sponsored mean? Let’s do a brief thought experiment. Consider a televised PGA tour event. When a product logo for an erectile dysfunction medicine appears on the screen and the announcer intones, “This portion of the Masters is sponsored by DRUG NAME HERE,” nobody out there in the viewing audience takes that to mean the “sponsor” has chosen the speed of the greens, the height of the rough or the pairing of golfers in the tournament. But say “sponsored” on a social media site and watch the sparks fly at internal regulatory review.”

Question for all of you: does that one simple statement make all of this debate about what you are responsible for seem a bit ridiculous all of a sudden? It did for me. It points out a perfectly created double standard that keeps social media as a pariah and “traditional” channels on the whitelist. Allow me to elaborate.

First, from Peter’s analogy, it’s okay if we “sponsor” a sporting event (or Race for the Cure or a NASCAR) and it doesn’t matter what appears next to our sponsorship. We don’t control, as Peter said, the pairings of golfers. Everyone’s fine with that. No one would assume otherwise because assuming otherwise would be insane.

But there’s more…

We don’t worry about what commercial follows ours on TV or what the news story leads into our commercial during the evening news.

We don’t care what ads appear above or below ours or what results appear on the same page as our paid Google AdWords.

We don’t think about what billboard is next to ours or what buildings it is near.

We don’t agonize over which stories are printed next to our ads in a magazine.

We don’t fret about which ads show up next to (or as a pre-roll to) our YouTube videos or channels. For example, here’s one of J&J’s videos (see red boxes):

I didn’t even bother highlighting the “Promoted Video” right under AOL’s ad.

So, how come regulatory and legal folks seem to be fine when we’re talking about TV, billboards, print, YouTube, Google, and yet worry about Facebook and some other places?

The FDA has never (read that last word again) told anyone that they are responsible for content they don’t control. So, if you place an ad or sponsor a section of a website, you should only need to worry about what you can control. You can control the content of what you give to the website to publish. That’s it. Of course, if you actually control more than that, then you’ve got a different issue. But you don’t control what ads show up next to your page on Facebook, so you’re not responsible for worrying about whether or not they cause your content to be in violation (side note: Facebook can actually turn off those ads in some cases, contact me if you need help).

Some of you might be saying that there’s a distinction between placing an ad (like a banner) and having a sponsored section. No way. You create the content for both and you dictate where each appears. For the sponsored section, you know where it’s going to go on the third party site (e.g., where on WebMD). For banner ads, you should know every single place where they show up. If not, talk with your media buying agency and get that info from them now. In each case, you created the content and helped decide on the placement. What you don’t get to decide is everything else that appears around it. Not the search results next to your Google AdWords, not the billboard under yours, not the TV commercial that follows your…none of these. Since you don’t control this why do you feel responsible? Why do you think that the FDA is going to come down on you? Show me one example and I’ll leave you alone.

We call these “ghost rules” around our office and they only do one thing really well: kill good thinking and innovation.

Rant over…thanks.

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

The Beginner’s Guide to Pharma Social Media

(image credit to WTFoodge)

After my most recent post, 10 Things I’m Tired of Hearing About Pharma Social Media, I received three basic responses. One type of response was complete agreement. These were in the minority, but there were a few. There were also those who partly agreed, but weren’t ready to come along completely. And, of course, there were those who completely disagreed. I’m pleased to say that this group was also pretty small.

The biggest overall objection I received was from people who said that if we stop talking about the ten areas referenced in my post, then for new people just investigating social media, they won’t ever have the chance to become more than beginners. That is, if there’s no one to tell them the basics, how can they understand the more complex issues? I suppose that’s a fair challenge.

Not wanting to leave anyone behind, I’m willing to help. However, I’m not doing this because I’ve reconsidered my position and think that people who have heard everything in my “10 Things…” need to keep hearing it. Nope. If we keep saying the same things over and over to the same people, it shouldn’t be much of a wonder that things aren’t changing. So, if you aren’t part of the “same people” group, then this post is for you. If you are, then skip this post and wait for my “10 Things I Want to Hear About Pharma Social Media” that will be coming soon.

Now then, for all the new people, a couple of warnings. First, this is going to take a bit of work on your part. I’m going to give you a lot links and show you where to find a bunch of presentations to review. It’s not for the faint at heart. If you really want to catch up and understand all the things that I discussed in my first “10 Things…” post, then you’ll need to invest a bit of your time. I’d estimate one day. Just one full day of your time to get all the way up to speed. Second warning: a lot of what I’ll refer you to comes from this blog, but not everything. So, you’ll have to do a little research on your own too. I’ll point you to some good sources, but you’ll have to do a little digging as well. I’m not the end all, be all commentator on social media.

I’ve divided this up into questions that I frequently hear new people asking about. They’re somewhat organized, but not meticulously. Dewey Decimal I’m not.

Here goes…

Why should I care about all this social media stuff anyway?

Easy one…just watch this.

This social media stuff is so restrictive. No companies in pharma or healthcare are really doing anything in this space. Right?

Wrong. You’ll find about 350 industry examples on the Pharma and Healthcare Social Media Wiki including Twitter, Facebook, YouTube, communities, and everything in between. That ought to be enough precedent for your lawyers.

Well, that’s quite a lot to review. Is there a smaller list?

Hmmm…I told you this wouldn’t be easy, but you’re in luck. Check out the 2010 Dose of Digital Dosie Award Winners. The Dosie awards were created to find the best examples of social media in pharma and healthcare. The nominees for the awards were drawn from the Pharma and Healthcare Social Media Wiki. If a site or program was listed on the Wiki, then it was a nominee. This means there were about 550 nominees, so we had to pare this list down to a set of finalists. The public voted for the finalists and then voted again on the finalists to pick the ultimate winners.

Are you really sure that companies are doing this already in pharma?

Yes, I’m sure. In fact, I just did a presentation about this (Pharma Social Media…Yes, It’s Possible). You can download the PowerPoint version of Pharma Social Media-Yes, It's Possible (1530 downloads) here. My only request: if you like it, tweet it (or LIKE! it)…spread the love.

As an additional service to all of you, I’ve taken the audio from my presentation and synced it up with the slides using SlideShare’s (frustrating-to-create-but-easy-for-you-to-view-tool) SlideCast. I’ve embedded it below.

Does anyone really use social media when it comes to healthcare?

If you just do a brief search on Google, you’ll find a ton of information about this. If you want a lot of it all in one place, then check out Pew’s “The Social Life of Health Information.” Read that and you’ll be quoting stats in no time. There are also some more stats in my FDA presentations (see below). What’s that? Don’t have time to search Google? Sure, sure. I can help. Click here for some resources.

Isn’t the FDA coming out with guidelines about social media soon? What’s the deal?

The answer is maybe. FDA has publicly said that they plan to release guidelines sometime in late 2010. However, there’s no guarantee that they will and there’s no guarantee how specific or vague these guidelines will be. That is, the guidelines might not be as much help as some marketers would like them to be.

Want some background on the hearings? Check out this post: FDA Public Hearing on Social Media Agenda and Speaker List Released, which includes links to the FDA site on this topic.

If you want some more comprehensive information about this issue including the ongoing debate on this topic by people like me, then follow the #fdasm hashtag on Twitter and also go through everything on the #FDASM site. (If you don’t know what a hashtag is…well, I’m not even going to answer that…)

If you’re wondering what people said at these hearing, the #FDASM site has links to all of the presentations. If you want to see what I testified about, then you can get those presentations here: A Sneak Preview of My FDA Social Media Hearing Testimony. If you want the “audio book” version, which features me presenting the slides at the actual hearing, you’re in luck. Here are both of my presentations:

There was a lot covered at the hearing, but there were few things that I expected to hear, but didn’t. Here’s my take on that from a presentation I did at a conference after the hearing. If you just want to review the slides on your own feel free to download a copy of my slides here:

Okay, so what about adverse events? I hear these are a big problem.

If I had a dollar for every time I’ve heard the words “adverse events” (AEs) in context to pharma social media, well, let’s just say I wouldn’t be writing this blog anymore because they don’t have WiFi on my private island. You’re not alone if you have questions about adverse events, but it’s not something that should stop all of your social media efforts.

Start with The Myth of Adverse Event Reporting and after that, if you’d like a little more detail, move onto 166 Reportable Adverse Events Equals One Red Herring. That should put the whole AE issue into some context.

One of the big issues around AEs is monitoring. Should you monitor conversations online knowing that if you see an adverse event you are responsible for reporting it? Well, my first take on this is that Pharma Should Forget About Social Media Monitoring. If you want some data why AEs should not impede your monitoring activities, then check out this post that I did with Nielsen: Monitoring Adverse Events in Social Media for Pharma’s Biggest Brands: Hopeless Task or Simple Project?

I’ve got some ideas for getting started in social media, but I’m not completely sure where to begin. Thoughts?

Plenty actually. Start with my post 9 Simple Steps to Getting Started in Social Media. That’ll tell you everything you need to know to…well…get started.  You might not be quite ready for that one though, so hold that thought. You probably have a bunch of other questions before you’re ready to jump in.

Actually, you’re right. I’m not sure what platforms or programs make sense for my brand, but I’ve got some ideas. We’d really like to <insert social media idea here>. What do you think of that idea?

Chances are that I don’t like your idea much. How can I say that without hearing what your <insert social media idea here> program is all about? Well, I’m going by what readers of this blog in the past have said would be their number one thing to do if they could do anything in social media. Ask yourself that question(and read the post): What If There Were No Rules in Pharma Marketing?

For a look at all the answers people gave in the survey and my commentary on why some of them might not be the best ideas, check out these two posts: Crushing Pharma’s Digital Marketing Dreams–Part 1 and Crushing Pharma’s Digital Marketing Dreams–Part 2.

Wow. Hadn’t thought of it that way. Are the benefits of participating in social media even worth all the risk?

Here’s a definitive answer for you: Yes. Or no. It depends on your brand, the disease it treats, and what you want to accomplish. Here are my thoughts on How to Make the Social Media Risk Worthwhile.

Okay, that helps, but what can social media do for my brands in pharma? How can I use it?

A lot of people have this question and a lot of people think that the options are endless. In fact, they are a finite number of options with an infinite number of customizations. In the end, there are really only 7 ways to use social media. Here they are: The Seven Uses of Social Media in Business — The 7 “C”s. An additional thought that’s specific to pharma (which fits under one of the 7) is to use social media purely to communicate risks of a product. I gave a talk about this once called (quite formally) “Communicating Drug Risk Using New Media Technologies.” What’s that? You’d like to take a look? Here you go…along with my narration (or download a copy: Communicating Drug Risk Using New Media Technologies (825 downloads))

How in the world am I going to get my idea approved? Our regulatory/legal/senior management/shareholders/general manager/grandmothers really don’t think this is a good idea.

You’re not alone. Good thing I created the 6 Steps to Getting Your Healthcare Social Media Idea Approved. Only 6 steps. They aren’t necessarily a walk in the park, but there are only six of them.

Anything I should know about participating in social media specifically in pharma or healthcare?

Actually, there’s a ton you should know. There are some rules that are general to participating in social media in general, but also others that are unique to pharma and healthcare. Here’s a presentation I did on this very topic:

If you’d like a copy of the presentation to review at your leisure, you can download the latest version (which is slightly different from the above) that includes all of my speaking notes. Here’s the link:

Annotated Version of Healthcare and Social Media...Know the Rules (1891 downloads)

How about some specific advice on using some of the different social media platforms?

Number one…go and review (and then copy) your colleagues. Check out what they’re doing by researching the examples on the  Pharma and Healthcare Social Media Wiki.

After that, for YouTube, try out these two: 8 Tips to Help You Own YouTube’s Search Results and The 10 Scariest Pharma and Healthcare YouTube Videos (so you see why YouTube is important). For Twitter, here are 140 Healthcare Uses for Twitter from Phil Baumann. Yep, 140 ideas…one for each character you’re allowed on Twitter. I don’t have a specific guide for Facebook, but if you’ve made it this far, you probably know what’s a good idea and what’s not.

Where is all this social media stuff going in the future?

One of my favorite topics. Try out these two posts: Your Choice: Your Privacy or Your Life? and Can Social Media Improve Your Health and Save Your Life? Yes, I’m serious about the last one. And, before you get too far ahead of yourself, be sure to check out 10 Healthcare Dinosaurs Digital Technology Will Make Extinct. Don’t invest too much in any of these areas.

We’re awesome. We’ve done all of this and more. What now?

Well, I’d like to take a ride on your pet unicorn someday, but in the meantime, why don’t you try, say, three of the Ten Digital Marketing Ideas Pharma Companies Will Never Try (But Should)?

____________

That’s it. If you went through everything, then I’m impressed. You should be well beyond most people when it comes to pharma social media. And, you likely understand why I’m tired of talking about the “10 Things.” You’re also in good position to join in on the debate when I share the things that I’d like to start hearing sometime in the next week or so.

If you still have questions after reviewing all of this, you’ve got two options. Go to the Dose of Digital page on Facebook and start a discussion or post a question on the Wall or contact me privately and I’ll do my best to answer your questions.

-