Fact or Fiction - FDA Has a Policy on Social Media?

This, apparently, is a stampede in progress....

Today the Post ran a story in its Health Section that had the headline "Drug Firms Jockey for Space Online" and when the story print continuity breaks and carries on to a subsequent page, the headline is "Drugmakers Seeking a Niche Flock to Online Social Media."  Emphasis my own.    

Flock?  Flock?  FLOCK?  The only way you could use the term "flock" in connection with pharmaceutical firms and social media is to say that companies are a scared flock of geese.  And they are frightened because they are regulated by an agency at FDA - DDMAC - which has a fundamental lack of understanding of how people use the Internet for healthcare and therefore does not understand how to regulate it.  The result has been regulatory action taken against companies where the rules are unclear and what seems clear one minute is completely unclear in the next.  

How many minutes in a video or Webcast before you have to mention the risk information associated with a drug?  If you mention a benefit, how much time do you have to mention the risk? Know the answer?   No, no one does.  Apparently DDMAC knew, but didn't tell anyone and the fact that no one knew of such a policy didn't stop DDMAC from issuing a warning letter to a Johnson & Johnson this month for violating that unknown rule.  According to the Warning Letter, the video was six minutes long with the risk information bundled at the seventh minute.  Would you have guessed that to be ok?  On a print ad, the risk information is at the end of a multi-page ad (and no one reads it).  What would the difference be?  No one knows, and DDMAC apparently makes this stuff up as they go along.   That is the kind of Whack-a-Mole game DDMAC plays.  We won't tell you what is off limits, until you do it and then WHACK!

Can a company respond to a request for information in a chat room?  When do companies have to report potential adverse events seen perceived in social media?  If a company makes a comment or entry on another Web site and leaves their own Web site information (as everyone does) have they tripped a regulatory wire?  How long into a YouTube video before a company has to mention risk?  Is it a minute, is it two - it certainly isn't six we have learned.  

Does risk information need to be included in a search engine ad that names the drug and what it is for when the placement of the risk information is no differently handled than in a print ad?  Years went by before DDMAC answered that one and apparently the answer was yes.  This, despite the fact that anyone who understands how the Internet is used would know that if a patient is interested in the drug mention, they will click on the link and land on the page with the risk information on it.

So many unanswered questions about the innumerable nuances of social media and the Internet, and an agency that keeps mum about the rules.  What is dysfunctional in that?

That is what was so shocking about the Post article was that its headlines imply this stampede to social media to promote drugs.  In fact, compared to other industries not hobbled by an ineffective regulatory body, the offerings made by pharma in the social media space have been nothing short of anemic, uncoordinated and lacking in sophistication.   And the number of companies actually doing anything at all out of the number of companies that actually exist is miniscule.  Anyone looking at the comprehensive forest would see that there are very few trees within it.

And that was what was so amazing about the statement from the FDA in this article.  Here it is:

"If drug companies or others working on behalf of drug companies wish to promote [their products] using social media tools, FDFA would evaluate the resulting messages as to whether they comply with the applicable laws and regulations.  our laws and regulations don't restrict thte channels that prescription drug companies choose to use for disseminating product promotional messages."

 

That is the same line they fed me during my podcast with DDMAC in March which turned out to be inaccurate when they issued the 14 untitled letters on search engine ads.  They are still sticking to their story - but take a whole dose of caveat emptor if you want to rely on it.

Because when formulating a social media endeavor, which pharma companies should be doing, be aware it is a Wild West venture - anything goes.  Apparently the Post thinks you might get caught up in a stampede, but in reality, it is much more likely some cowboy at DDMAC might mistake you for a mole.  

Comments

[Robin Robinson]

You go, Cowboy! Love your passion and your reasoning. I think you are right on target. Too bad the Post didn't call you for an interview.

[locus]

Are you aware that DDMAC will review any advertising materials and give feedback on them to industry before they go public? (The italicized portion of this post alludes to this.) Does this change some of your argument about FDA reacting to the newest internet advertising techniques?

I agree that FDA needs to develop its policies over internet advertising, but they must follow the regulations as written. If a company decides to advertise its products in a novel manner, nothing is stopping them from getting DDMAC's opinion on it before it goes live.

[Mark Senak]

Hi and thanks for your comment. Yep, I'm aware of the fact that FDA can review. I'm also aware of the fact that the time it would take for review would be considerable and kind of takes the immediacy out of social media. The agency should not leave people to guess the policy - they should interpret the regulations and enunciate the policy. To do otherwise is a waste of dollars and time. That is their role, and they have in effect, abdicated it. The emergence of new media makes it incumbent on them to interpret how regulations will be enforced vis a vis their use.

[MaverickNY]

Dysfunctional, toothless and pitiful are some of the nicest things one might say about the FDA and DDMAC right now. However, this situation isn't new, it's been going going on for some time, way back to even the web1.0 world where there was very little (read none) guidance about websites.

I vividly remember submitting artwork for pens and pads with the company name on them and DDMAC's first comment was that this was promotional and required fair balance! You want to put fair balance text on a pen? That's how bad it used to be and clearly, the lack of clear, precise instructions still prevails so is it any wonder that companies and review committees are nervous about taking steps in social media?

No wants to be the brand team that gets the dreaded wrist slap letter with all the internal politics and hand wringing that involves.

It's a real shame but you have to wonder about the leadership at the FDA - maybe it will change and become more transparent with the new heads. We can but hope.

[Veritatis Cupitor]

Why is it there are never any more than 2 or 3 comments on your blog posts? Is it because you don't have many readers ? Maybe you have data that says otherwise. If you do, then one can only conclude that there is some other reason for the lack of commentary or discussion about your posts.

In the business world, companies that are successful typically have clearly defined core values and align their processes and actions with those values. Those that do not, ultimately cease to exist. So looking at your blog from a business perspective, I have to ask myself...What are Mark's core values. He sure has a lot to say about FDA and public health and sure does seem to be passionate about it. So one of his core values must be promoting the public health. So logically , the next step is to see if his actions are aligned with his values. Well...He does criticize quite a bit, always seeming to have a better solution to a myraid of problems. Maybe some of them are good ideas, maybe not. But are complaining and criticizing really the most effective way to promote the public health. Are his actions aligned with his values? Perhaps your readers, regardless of the number, see through the shallow passion you profess to have for promoting public health. Seems to me, with your experience, you could probably land a position with the Agency you lambast so often. Then, you could spend everyday and every action in aligment with your core values. Think about it, the opportunity to drive policy changes from the inside. Surely this would be an ideal alignment and much more effective means of promoting the public health. But alas, perhaps your zeal for public health is a mere facade, masking your true values..."to help pharma and biotech companies" (from your bio) and ultimately making you more money. What's that? Your offended by my assertion that money is more important to you than promoting the public health? Well, then prove me wrong....I'm sure the agency has positions open for attorneys. In fact, DDMAC (who you seem to be obsessed with)has a few openings for attorneys according to their organization chart. Live your passion brother! Give up that high paying position with Fleishman and go to work to make a difference! I won't hold my breath.

You're no different than our CEO who claims that our first responsibility is to the patients, yet institutes business practices that aren't aligned with that value. I'd tell him the same thing if I could, but one of my core values is staying employed.

[Rob]

I'm really glad you are keeping an "eye on FDA" about this! We're all very confused about the regulations, and would welcome some guidance, and explicit guidelines.
Thanks,
Rob

[Barbara Bix]

I'm not sure if I got the gist of the post or not. Here's the source of my confusion.

This post seems to focus on using social media to acquire customers. As you note, the FDA regulates what a company can say or do when marketing or selling to customers. As such, it's not unreasonable to expect the same restrictions to apply to social media campaigns that apply to conventional campaigns.

That said social media has many other valuable applications--which may not be restricted by the FDA. One example is listening to the concerns that stakeholders have about particular diseases or treatments. This is what Glaxo did before they launched Alli when they launched a forum to discuss weight loss challenges and successes.

The question that this post raises for me is, "Is social media the best strategy for customer acquisition?" By its very nature, the goal of social media is to engage prospects, customers and others in a conversation--rather than to pitch them. Companies might be better served if they use this media for marketing research and/or branding--and use conventional marketing campaigns for customer acquisition.

By the way, I'm not sure if listening is also regulated by the FDA so someone else may want to comment on this.

[Mark Senak]

Barbara - Actually your point is interesting in that I had not thought of it as using social media to pitch or acquire customers. I considered it from the patient point of view - when I go on line to look for information about healthcare, I want to be able to find it. Now if I put in search terms along disease lines what I will see are people selling ads about "natural" and "herbal" "cures" but the ads about legitimate medicine are missing - which to me anyway is a lack of fair balance in the market place. Of course, it is expected that pharma have to act along the same lines as other forms of communications that are regulated, but my point is that just as there are different rules for print and media, there are significant nuances to the Internet that present circumstances and questions not resolved by looking to print or broadcast rules to solve. So in the FDA's failure to enunciate policy that is specific to the Internet in the same way they have enunciated different policies for print from broadcast, we have a problem.

[Ed Berger]

Your demand that FDA "interpret the regulations and enunciate the policy" to provide certainty to "publishers" may be reasonable for mature media, but is unrealistic for emerging/evolving media. FDA is in a learning mode about social media, just as the applications and capabilities of social media are still being explored and developed. In such a situation, practical regulatory standards (as opposed to principles) will necessarily evolve on a case-by-case basis before they are codified. It is part of the price of being on the cutting edge - sometimes you nick yourself. Most importantly - if you push FDA into making explicit policy statements specific to social media too early in the learning curve, those policies will be more restrictive than the ones that evolve organically. Best advice - Chill.

[Mark Senak]

Thanks for commenting but I strongly disagree. Neither patients nor industry are well served by the status quo