Thursday, January 22, 2009

New Media, Old Regulations: Like Oil and Water, They Don't Mix!

I just learned that oil and water do not mix!!! Unbelievable! Who knew? You can try this experiment and find out for yourself.

Know what else don't mix? New media (aka, social media) and Old FDA regulations.

My new friend, John Murray, a former regulatory professional employed by pharmaceutical companies, now a consultant and blogger (see here), gave a great example of this "failure to mix" phenomenon in a comment to my post "The Real Reason Why Pharma Hates Social Media Marketing":

"Posts or comments in any blog that end up having product mentioned or discussed causes that blog, or at least that post, to be a form of labeling," said Murray. "That means, for most companies, that that content needs to go through a medical, legal, regulatory review before dissemination. More importantly, labeling (in this case promotional labeling) and advertising must (and I mean must) be submitted to FDA on what's called a 2253 form "at time of initial dissemination" according to the regulations. This requirement in and of itself makes it near impossible for companies to do any real time blogging related to any of their products, and also requires them to pre-review comments on a pass-fail basis."

What this situation requires, IMHO, is some good NEW-fashioned DETERGENT! I've pointed out many times before that the FDA MUST update its regulations and guidelines to keep up with technology -- see, for example, "Where's DDMAC's Head At?"

Regulations, which reflect how regulatory agencies intend to assure that the law is followed, can be changed. Now that Obama -- who carries a Blackberry! -- is president, perhaps he will nominate a similarly techno-savvy FDA Commissioner who will spearhead the revision of FDA regulations and guidelines so that they are in sync with today's world. One caveat: the drug industry may fight tooth and nail against any revisions. You never know what can happen when a government agency sets out to make substantial changes in how it regulates.

We can help by putting pressure on both the FDA and the industry to come up with guidelines for pharmaceutical marketing via the Internet. I suggest that my ePharma Pioneer Club™ members (and would-be members) get together and draw up some examples for the FDA/industry or suggest a public hearing on the matter.

I only note, with regret, that I was a member of an FDA-hosted public hearing about the Internet way back in 1997! Nothing ever came out of it, except for the Internet Healthcare Coalition that I founded to fill in the gap and develop a set of self-regulatory standards. Even that was better than a sharp stick in the eye, which is what ePharma social media marketing pioneers are faced with today.


  1. Anonymous12:36 PM


    You got me. Of course, we can and should make an attempt to update the regulations. We should convert the country's fuel supply to natural gas, get Pete Rose in the Hall of Fame and revamp the tax code, among other things. You'll hear the regulatory and legal responses echoing across the nation "do you know how long it takes to revise and pass new regulations (that haven't been significantly revised since the 60s")? Its pretty true that this is likely to be a long and hard effort.

    Nonetheless, nothing ventured nothing gained. Perhaps someone should create a model example of how different social media vehicles should look and work (one that supports what FDA regulations should encourage and prohibit) and then draft a regulation (or guidance) that ensures these needs (if you wait for FDA to draft such a regulation or even a guidance document, you might as well wait for the first manned Mars mission).

    Of course if you draft anything and you are not a government employee, you will be roundly criticized for being self interested and your document will be bashed. Just be prepared. That shouldn't stop people from advancing a decent purpose. For grown ups, harnessing self interest is actually good policy.

    Sounds like a task for someone.

  2. What Do Yoga and Social Networking Have in Common?

    In my many years as a yoga practitioner (or yogini as they say) I heard the same thing many times from those that felt unfit or unable to practice yoga: "Oh, I could never take on yoga, I can't even touch my feet..." My answer to them was always the same, 'anyone can do it', and if you stick with me for a couple of paragraphs I will explain how this statement relates to my conviction that even the pharma industry can embrace and practice web 2.0 and social networking.

    Last week I was in New Brunswick, NJ at the PharmaMed Marketing and Media Conference. Rubbing shoulders with marketers and life sciences executives alike, I listened to great "lessons learned" from successful media campaigns, including tactics to engage patients and HCPs, insights on how to improve patient compliance, and how to address regulatory hurdles. I also observed that when it comes to social networking and Web 2.0 some pharma marketers are still thinking about blogs and patient forums as the point of entry into the new media, in other words, they are trying to touch their toes before the long series of stretches that such an achievement requires.

    An experienced yoga teacher will structure her/his class so each exercise is built upon the former exercise in the sequence, in a progressively more complex way. The teacher will spend more than half of each class building upon isolated exercises that open up each part of the body before the dreaded Paschimottanasana, or head-to-toe forward bend, is introduced. Only someone that does not understand yoga would think that one must be able to touch their toes in order to engage in this greatly beneficial practice.

    Beginner yogis are taught basic but effective principles of alignment and balance. To an unexperienced observer, those beginner classes look very easy and almost rudimentary. However, they are very effective in a few ways - they set the foundation for more audacious and complex movements, but most importantly they set a framework and mindset that is fundamental to the entire practice of yoga.

    Bringing it back to our marketing world:

    Web 2.0 and social networking can be defined by a number of tactics and tools to engage users, distribute user-generated content, and promote online collaboration. Yes, blogs are a great example, user forums as well, but there are a large number of tactics that are much safer for the pharma industry and that should be considered first before diving head first into the new media world.

    An online savvy marketer will build a web 2.0 strategy with RSS feeds, podcasts, video, wikis as these are perfectly safe and 'containable' practices and won't immediately result in a veto from your regulatory department. As in the yoga world, those initial tactics can be the foundation for the new media strategy, they will spark discussion and lay the foundation of a web 2.0 practice within both marketing and legal departments. As the regulatory environment evolves and the industry becomes more comfortable with the new media, the strategy can be expanded to include bolder initiatives such as a YouTube channel (this belongs in the first group) a corporate blog with comments, patient forums, or Facebook pages and groups.

    For now, let's stick with the basics, for example:

    Enabling users to subscribe to your content through RSS will enable you to deliver your content to this user in real time and within context. A De.licio.Us icon within your site will encourage your audience to share your content with their network of family, friends or peers. A YouTube channel with educational videos for patients that support your brand within particular indications. These are all 'web 2.0' tactics, that allow you to learn the basics, build your foundation, and stretch before you try to touch your toes!



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