The First and Only Regulationships FDA Social Media Public Meeting Award Goes to.....
11/13/09 14:36 Filed in: Social Media Regulation
Now that FDA's Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools is over, Regulationships.com would like to take this opportunity to announce its first and only Most Important Presentation Award. I thought long and hard about this (or at least as long as my Acela ride back to Philadelphia). It was a hard choice among a lot of great presentations from a host of diverse people interested in FDA regulation.
It would be too easy to dismiss the roles of persons involved in social media regulation, because they are not in a regulatory or legal role. At this week's FDA public meeting on regulation of the internet and social media, the substantial majority of speaker participants could be classified as "service providers." These are people who are providing services to the companies that are directly regulated by FDA, but these are not the people or companies who are directly regulated. This does not mean they are not directly affected by FDA's regulatory policies. Far from it. Many of the service providers are online marketing and communication agencies, ad agencies (or both), or a variety of companies providing portals or communities for which manufacturer participation (and sponsorship) is far lower than its potential. My point is, that everyone has a voice in FDA's guidance making process, and for the most part, everyone represented the collective interests of the regulated very well.
But today, I'm going to tell you who's participation was perhaps most noteworthy, and it might make you scratch your head.
First, understand that the public hearing, while important and impactful to FDA, is only a scratch in the dent of progress. FDA repeatedly reiterated that all parties should post their comments to the official docket by February 28, 2010. A lot of details sailed passed FDA's ears during the November 12 and 13 hearing. Many good thoughts and ideas dissipated into the ether, but that is ok and to some extent it is by design. The formal commenting process is designed to ensure that the full range of comments are captured and documented through official submissions to the docket. FDA's public hearing serves its greatest value in giving a vivid impression of the issues and tasks at hand. I think clearly that FDA was impacted positively in the need to modernize its regulation and policy and even its overall mentality.
The First and Only Ever Award for Most Important Presentation at FDA's Public Meeting on the Internet and Social Media
This all brings me to my winner for the most important presentation of the meeting. That distinction goes to none other than John Mack, aka Pharmaguy, and owner and author of the Pharmamarketing Blog. As a regulatory and compliance person trained in the art of formality and decorum in regulatory issues and proceedings, I am inclined toward the unqualified reverence of participants, much the way I expect the FDA panel is. John Mack, on the other hand, stood for the authenticity of the issue of social media regulation. Although substantive and largely respectful, John was unbound by the decorum someone like me would have been chained to. I could see FDA squirm as John's slides showed images of John's blog character "FDA Intern" and then on day two, John's fictitious pitch for the Social Media Hearing t-shirts. Heck, I squirmed myself. I said to myself, "John don't, it's just not necessary." The impressions of the "FDA Intern" cartoon and the fictitious pitch to sell t-shirts perhaps made the biggest impression on the FDA panel as they tried to stay as stone faced as possible. But in and among these images or slides, John did present survey data (albeit as John himself pointed out "non-scientific" survey data). The data are every bit as interesting as other data presented that day, because it represented a less formal but "rank and file" perspective on industry issues in social and internet media. But lets get something straight. Most data on internet behavior is exploratory behavioral research--certainly not of the precision, conclusiveness, and generalizability of the studies that FDA requires for conclusions of efficacy and safety about drugs. As far as I'm concerned, it is all anecdotal research. Some is a bit more relevant to certain issues, but its conclusiveness and generalizability beyond the sample studied is questionable, at least under FDA standards. FDA considers most of these types of surveys to be pseudo science when applied to actual medicine and product efficacy and safety. [In spite of its perceived confirmatory or inferential quality, there was indeed a stunning collection of research presented that I believe will ultimately be the biggest catalyst for changing policy, but more on that in later posts.]
Representing the Untidy World of Social Media and, Ultimately, Its Regulation
The most important reason that I think John Mack's presentation was most noteworthy relates to what it represents. For all the formality, reverence, and structure of public health policy making, no one can escape the cold hard reality that regulatory policy making is an inanimate set of rules and principles that are applied to the animate and living world. The application of rules and principles to the animated and "real" world of medicine and medical communication is "messy." That's right, its a mess. It's unpredictable and all at once triumphant and tragic. It's full of despair, promise, elation, happiness, apprehension, and the miracle of life given meaning by the stark juxtaposition of the sadness and inevitability of sickness and death. Most of what I saw at FDA's public meeting was a highly professional and thoughtful collection of constructive thoughts and ideas, but I've been in this business too long to know that this isn't the everyday world of healthcare commercialization and communication. In reality, there are way more moving parts and vastly divergent pressures, incentives, issues and intentions. It is, perhaps at best, a reflection of the everyday world of public hearings.
What John Mack's presentations represented for me was that we need to be reminded of how medicine makes us squirm. It's no comfort zone and what you think and the way you go about things can only be planned and sterilized so much. In drug advertising and promotion we depict benefits but disclose risks. Even in the most legal and informative piece of FDA-compliant communication, companies don't depict the blood-stained floors or emergency rooms, or getting headaches, or sitting on the toilet with diarrhea even though these might be serious or common side effects disclosed in the advertisement. What is depicted are people living their lives, not too well and not too unwell, presumably due to the drug or medical product being advertised. Neither the risks or the benefits portrayed provide a full range of the relevant medical issues (either positive or negative). Regulatory medicine is not real medicine and even the everyday world of drug regulation bears only a slight resemblance even to sterile atmosphere of the public hearing. Having said this, I also want to acknowledge Diane Zuckerman, patient advocate Kim Witczak as well as Alan Coukell whose organization petitioned FDA for a hearing just like this way back in December 2008 (before FDA created a stir by issuing 14 letters on sponsored links). They also are distinguishable in another way. They authentically represent people who who don't have a commercial interest FDA's regulatory policy. I was actually more surprised that there wasn't more representation from commercially disinterested parties.
But, getting back to John Mack, the challenge to our formal sensibilities from his FDA Intern and T-shirt slides were perhaps a bit more unexpected. I do think John has and will continue to have an important voice in pharma marketing issues. I don't agree with everything John says, I don't agree with all the ways in which John communicates on the issues, and I can't promise you that I won't fry him in one of my own blog posts sometime in the future. In fact, I took exception to some of John's survey data (or at least how the results were presented). But, nonetheless, John represented an authenticity that no other speaker represented, at least from a pharma marketing perspective (Diane Zuckerman, Alan Coukell, and Kim Witczak excluded). We need to be reminded that policy making should not be frozen by fears of unintended outcomes or consequences and that policy making and enforcement takes a human and flexible approach to reacting to the real, beautiful, grotesque, irrational and unpredictable world.
John Mack Best Represented the Complexity of a Regulationship
John Mack best represented what a "Regulationship" is--an unwieldy, somewhat unregimented, unorthodox, valuable and inevitable continuum of relationships between people, places, and things impacted by regulation and policy. An attempt to fit the unorthodox and unpredictable into an orthodoxy. John Mack, the "concerned party," blogger, tweeter, critic, advocate and satirist is a player on the regulatory policy field of social media. The crux of regulatory and business issues in social media is the organic nature where everyone is a potential participant and stakeholder. Here, John Mack is a player on a field where FDA and industry doesn't get to decide who plays. This is the very embodiment of the challenge of social media regulation. We don't get to decide who is a player in the social media world when you begin a multidirectional communication. FDA then has to figure out if and how do regulate communication in each direction. Who has what regulationship to what? How does that regulationship determine regulation?
Congratulations, John Mack. Unfortunately, you don't get any tangible reward for this distinction, other than my current respect for what that's worth.
It would be too easy to dismiss the roles of persons involved in social media regulation, because they are not in a regulatory or legal role. At this week's FDA public meeting on regulation of the internet and social media, the substantial majority of speaker participants could be classified as "service providers." These are people who are providing services to the companies that are directly regulated by FDA, but these are not the people or companies who are directly regulated. This does not mean they are not directly affected by FDA's regulatory policies. Far from it. Many of the service providers are online marketing and communication agencies, ad agencies (or both), or a variety of companies providing portals or communities for which manufacturer participation (and sponsorship) is far lower than its potential. My point is, that everyone has a voice in FDA's guidance making process, and for the most part, everyone represented the collective interests of the regulated very well.
But today, I'm going to tell you who's participation was perhaps most noteworthy, and it might make you scratch your head.
First, understand that the public hearing, while important and impactful to FDA, is only a scratch in the dent of progress. FDA repeatedly reiterated that all parties should post their comments to the official docket by February 28, 2010. A lot of details sailed passed FDA's ears during the November 12 and 13 hearing. Many good thoughts and ideas dissipated into the ether, but that is ok and to some extent it is by design. The formal commenting process is designed to ensure that the full range of comments are captured and documented through official submissions to the docket. FDA's public hearing serves its greatest value in giving a vivid impression of the issues and tasks at hand. I think clearly that FDA was impacted positively in the need to modernize its regulation and policy and even its overall mentality.
The First and Only Ever Award for Most Important Presentation at FDA's Public Meeting on the Internet and Social Media
This all brings me to my winner for the most important presentation of the meeting. That distinction goes to none other than John Mack, aka Pharmaguy, and owner and author of the Pharmamarketing Blog. As a regulatory and compliance person trained in the art of formality and decorum in regulatory issues and proceedings, I am inclined toward the unqualified reverence of participants, much the way I expect the FDA panel is. John Mack, on the other hand, stood for the authenticity of the issue of social media regulation. Although substantive and largely respectful, John was unbound by the decorum someone like me would have been chained to. I could see FDA squirm as John's slides showed images of John's blog character "FDA Intern" and then on day two, John's fictitious pitch for the Social Media Hearing t-shirts. Heck, I squirmed myself. I said to myself, "John don't, it's just not necessary." The impressions of the "FDA Intern" cartoon and the fictitious pitch to sell t-shirts perhaps made the biggest impression on the FDA panel as they tried to stay as stone faced as possible. But in and among these images or slides, John did present survey data (albeit as John himself pointed out "non-scientific" survey data). The data are every bit as interesting as other data presented that day, because it represented a less formal but "rank and file" perspective on industry issues in social and internet media. But lets get something straight. Most data on internet behavior is exploratory behavioral research--certainly not of the precision, conclusiveness, and generalizability of the studies that FDA requires for conclusions of efficacy and safety about drugs. As far as I'm concerned, it is all anecdotal research. Some is a bit more relevant to certain issues, but its conclusiveness and generalizability beyond the sample studied is questionable, at least under FDA standards. FDA considers most of these types of surveys to be pseudo science when applied to actual medicine and product efficacy and safety. [In spite of its perceived confirmatory or inferential quality, there was indeed a stunning collection of research presented that I believe will ultimately be the biggest catalyst for changing policy, but more on that in later posts.]
Representing the Untidy World of Social Media and, Ultimately, Its Regulation
The most important reason that I think John Mack's presentation was most noteworthy relates to what it represents. For all the formality, reverence, and structure of public health policy making, no one can escape the cold hard reality that regulatory policy making is an inanimate set of rules and principles that are applied to the animate and living world. The application of rules and principles to the animated and "real" world of medicine and medical communication is "messy." That's right, its a mess. It's unpredictable and all at once triumphant and tragic. It's full of despair, promise, elation, happiness, apprehension, and the miracle of life given meaning by the stark juxtaposition of the sadness and inevitability of sickness and death. Most of what I saw at FDA's public meeting was a highly professional and thoughtful collection of constructive thoughts and ideas, but I've been in this business too long to know that this isn't the everyday world of healthcare commercialization and communication. In reality, there are way more moving parts and vastly divergent pressures, incentives, issues and intentions. It is, perhaps at best, a reflection of the everyday world of public hearings.
What John Mack's presentations represented for me was that we need to be reminded of how medicine makes us squirm. It's no comfort zone and what you think and the way you go about things can only be planned and sterilized so much. In drug advertising and promotion we depict benefits but disclose risks. Even in the most legal and informative piece of FDA-compliant communication, companies don't depict the blood-stained floors or emergency rooms, or getting headaches, or sitting on the toilet with diarrhea even though these might be serious or common side effects disclosed in the advertisement. What is depicted are people living their lives, not too well and not too unwell, presumably due to the drug or medical product being advertised. Neither the risks or the benefits portrayed provide a full range of the relevant medical issues (either positive or negative). Regulatory medicine is not real medicine and even the everyday world of drug regulation bears only a slight resemblance even to sterile atmosphere of the public hearing. Having said this, I also want to acknowledge Diane Zuckerman, patient advocate Kim Witczak as well as Alan Coukell whose organization petitioned FDA for a hearing just like this way back in December 2008 (before FDA created a stir by issuing 14 letters on sponsored links). They also are distinguishable in another way. They authentically represent people who who don't have a commercial interest FDA's regulatory policy. I was actually more surprised that there wasn't more representation from commercially disinterested parties.
But, getting back to John Mack, the challenge to our formal sensibilities from his FDA Intern and T-shirt slides were perhaps a bit more unexpected. I do think John has and will continue to have an important voice in pharma marketing issues. I don't agree with everything John says, I don't agree with all the ways in which John communicates on the issues, and I can't promise you that I won't fry him in one of my own blog posts sometime in the future. In fact, I took exception to some of John's survey data (or at least how the results were presented). But, nonetheless, John represented an authenticity that no other speaker represented, at least from a pharma marketing perspective (Diane Zuckerman, Alan Coukell, and Kim Witczak excluded). We need to be reminded that policy making should not be frozen by fears of unintended outcomes or consequences and that policy making and enforcement takes a human and flexible approach to reacting to the real, beautiful, grotesque, irrational and unpredictable world.
John Mack Best Represented the Complexity of a Regulationship
John Mack best represented what a "Regulationship" is--an unwieldy, somewhat unregimented, unorthodox, valuable and inevitable continuum of relationships between people, places, and things impacted by regulation and policy. An attempt to fit the unorthodox and unpredictable into an orthodoxy. John Mack, the "concerned party," blogger, tweeter, critic, advocate and satirist is a player on the regulatory policy field of social media. The crux of regulatory and business issues in social media is the organic nature where everyone is a potential participant and stakeholder. Here, John Mack is a player on a field where FDA and industry doesn't get to decide who plays. This is the very embodiment of the challenge of social media regulation. We don't get to decide who is a player in the social media world when you begin a multidirectional communication. FDA then has to figure out if and how do regulate communication in each direction. Who has what regulationship to what? How does that regulationship determine regulation?
Congratulations, John Mack. Unfortunately, you don't get any tangible reward for this distinction, other than my current respect for what that's worth.