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John Soat

FDA Questions Big Pharma's Online Presence

Written by John Soat
11/24/2009 8 comments
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When pharmaceutical companies advertise online or via email and text messaging -- or by interacting in social media such as blogs, Facebook, or Twitter -- who’s making sure they’re adhering to the strict requirements the U.S. Food and Drug Administration imposes concerning any discussion of their regulated products?

The FDA held a two-day hearing earlier this month to discuss the thorny issue of how pharmaceutical companies should market their products online and in social media. The hearing was held in the National Transportation and Safety Board Conference Center in Washington and featured more than 60 15-minute presentations by representatives of big pharma, public interest groups, public relations firms, and Internet companies, including Google (Nasdaq: GOOG) and Yahoo Inc. (Nasdaq: YHOO).

A 12-member panel from the FDA’s division of drug marketing, advertising, and communications interacted with the speakers. The FDA will consider whether to issue new guidelines concerning Internet-specific regulations.

As anyone who watches television or reads magazines knows, the FDA requires drug companies to be as clear as possible about their claims for their products and to include an explanation of any potential risks related to their products in their ads.

Apparently, when it comes to search engines, social networks, and the blogosphere, those regulations have been more honored in the breach. Last April, the FDA sent warning letters to 14 companies, including Eli Lilly and Merck, about their online marketing practices, according to a Reuters article about this month’s hearing.

It’s an important issue, as more and more consumers turn to the Internet for information about products and services. Especially in the case of certain demographic groups, such as the elderly, accurate data about drugs and medication is vital. Also, more people are joining social networks and using digital forms of communication, such as text messaging or Twitter, which makes those avenues viable (and valuable) marketing venues.

Drug companies and marketers contend that such forms of communication don’t allow for long, detailed descriptors, information about risk, or warning labels.

The hearing has generated considerable discussion among interested parties in forums and blogs over the last week or so. Here are summaries of some of those discussion points:

  • The Internet is an important source of healthcare information, and consumers need to be assured the information they are receiving is accurate and objective.

  • Social networking is an increasingly important way for companies to interact with their customers, but drug manufacturers and marketers are unclear about FDA requirements or regulations in this regard.

  • Who’s responsible for the information disseminated by marketers and advertisers? “We don’t think companies should be responsible for policing the entire Internet for information about their products,” said Johnson & Johnson executive Elizabeth Forminard at the FDA hearing, according to the Reuters story.

  • How much (or, how much more) should the feds be involved in online activities? Do we really need or want federal regulators monitoring discussions going on in social networks and the blogosphere to ensure drug firms and marketing people are adhering to guidelines?

Several proposals were made at the hearings for how to go forward:

    1) Pharmaceutical companies should be limited to promoting their products on their own Websites, where the content can be monitored by regulatory agencies.

    2) The FDA needs to hire enforcers who are familiar with the social Web and can monitor discussions by pharmaceutical companies and their representatives about the efficacy and potential hazards of their products and those of their competitors.

    3) The FDA should create a logo that pharma companies can use in search engine advertisements, on social networks, and on Twitter to alert consumers to where they can find FDA-mandated risk information about the products being advertised or discussed.

The FDA will accept written or electronic comments on the issue until February 28, 2010. For instructions on filing comments, go here.

— John Soat is a freelance journalist who specializes in business, technology, and security.

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Fiercesome
Rank: Scrivener
Monday November 30, 2009 11:32:25 AM
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Just for a bit of behind the scenes, I used to work at the NLM (National Library of Medicine) and I also ran a retail pharmacy in a former life.  Pharmaceutical companies are put through the wringer by FDA regulations.  There may be a cure for the common cold out there but you won't hear about it for six years until it is fully vetted and then approved.  (I'm exaggerating, obviously.  Not about the time frame but about the "cure".)

About 15 years ago, the FDA regulations on drug/side-effect disclosure got drastically tighter.  Just to rip the fodder away from poor stand-up comics, the drug companies were required to reveal ALL side effects experienced by any member of a test study.  So therefore, out of 1,500 people, if two of them got a nosebleed, that has to go into the list of "potential" side effects.  If you've got a drunk signing up for test studies and shows up hung over for his $50, takes the trial, and has a headache afterwards, it gets documented.  That's why those television commericals seem so long on the list of "potential side effects" as compared to what the drug actually does for you.

Not contributing to the article particularly, just thought I'd pull back the curtain for a second.

 

Mr. Roques
Researcher
Wednesday November 25, 2009 7:34:47 AM
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But then again, how many warnings can you write in 140 characters or less? "Buy Aspirin from Bayer, for your headaches, etc, etc... oh and if you have this or that, or that, or that, or that... (re)... go to your doctor"

bauerb
Rank: Scrivener
Wednesday November 25, 2009 7:12:58 AM
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that was not my point. Social Media portals like FaceBook are not the ideal places to throw up healthcare billboards. the lights are already too blinding...

What Social Media does for us however, and this was the heart of my post, is show us who people are, what they do, and what they like.  We can learn as much as we need to know if we track social media statistics back using forensic social anthropology. 

What I find so interesting is that the Engagement Layers placed ontop of common-denominator social science are often so blindingly effective, we think that the magnetism of the new site is "dark magic". 

People don't change really change their social behaviors.  this message is lost because so many high velocity enablers are placed just a mouse-click away.  But, Social Mean Reversion is a stronger force. and when FaceBook is gathering dust on the Pop Phenomona archives shelf next to the Spice Girls and Saved by the Bell, we will all scratch our heads, and someone will write a book, and the book reviews will get debated on "NewSocialMediaFrenzy.com". and I will ask you to be my "NSMF Pal"

ChrisTOP
Thinkernetter
Wednesday November 25, 2009 12:12:17 AM
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While it goes without saying that pharmaceutical companies should be as forthcoming as possible in regards to FDA regulations, it seems to me that you shouldn't automatically trust something you saw a banner for on your way back to the farmvile page. 
 
In short, if you have a question about some kind of medication, consult a physician. 

bauerb
Rank: Scrivener
Tuesday November 24, 2009 4:43:29 PM
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lets combine Universal Healthcare with Outcomes based Reimbursements.  Then to make it more fun, lets completely restrict one of the most cost effective forms of patient communication.  and if thats not fun enough, lets whip up a frenzy of Health2.0 Tech initiatives and not let Pharma play. 

Its really, really easy to criticize health reform. it is really, really hard to make meaningful changes.

I work with big pharma on these challenges daily. I also work with patient groups, payers, and HCP's.  I drive my computer into the eye of the storm on a daily basis.  what do I think?  the most impactful, best performing solutions to solve some of these problems are going to be the ones that are modeled after the people who define the system that we are trying to change: the patient. and because we are all patients of some form or another, and because we are all different, and because many of us are a litlle "funny in the head", the solutions taht will work will be so different from anything that has been seen before that these solutions, when unveiled, will be prodded, poked, scorned, criticized, and otherwise trashed by the same people who, if they took a really good honost look inside themselves, would realize that these new solutions were not created in the Pharma Lab, they were created by modern day Cultural/Social Anthroplogists with advanced degrees in Facebook, and Mafia Wars. the next generation of effective, impactful healthcare tools will be a mirror into our collective souls, and will look as funny as we do. but guess what, the solutions will fit like a fuzzy network of friends on Ning, and offer so little resistance that in between photo tagging and mafia hit jobs, we won't even notice that we are adhering to sublte, but important behavior modifications.....

tnieusma
IQ Crew
Tuesday November 24, 2009 2:47:19 PM
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I formally worked very closely with labeling in OTC pharmaceuticals. I can say that there are MANY regulations regarding print that are watched and adhered to very diligently. However, from a marketing perspective, there is also a close eye kept on any available loopholes. After all, there is a bottom line being watched.

That being said, if there is a way to avoid using 100% of the required warnings, it will happen. If it is mandated that the disclosures be available, I'm sure that a link of some sort to the company site would be simple enough.

As you point out though, the trouble is in the policing of the situation. With labels and ads, there are required submissions to the FDA with every change and companies dare not break that rule. In cyber-space, that is certainly more difficult to keep up with.

You can be certain though that each marketing department is tracking and searching for every comment, post, etc. related to their products. Therefore, it is not impossible for them to look at it from a regulatory perspective as well; providing the proper incentive to do so exists. The fact is that many folks consult the web for pharmaceutical information and the danger of misinformation leading to dire consequences is real and should therefore be addressed.

John Soat
Thinkernetter
Tuesday November 24, 2009 12:31:27 PM
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There's a fundamental question here concerning the nature and function of social networks, and that is: What's the difference between interaction with constituency and potential customers, and marketing and advertising copy? If the pharma companies want to create dialogues with their customer base, do they have to incorporate regulatory language into every blog, tweet, or social network posting? Does the word "casual" ever apply to what pharma companies, or their representatives, have to say about their products?

Mary Jander
Thinkernetter
Tuesday November 24, 2009 12:16:17 PM
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The kinds of extensive qualifications required by the FDA for TV and magazine drug ads might make it tough to adapt pharma messages to social sites. Where's the room on Twitter for things like "may cause involuntary throat closure that can in rare instances prove fatal"?

Still, the pharma firms found a way to work other media and they'll no doubt find a way onto social sites as well.

 

 

 

 

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