FDA Social Media Guidelines: Irresponsible? - Pharmaceutical Executive

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FDA Social Media Guidelines: Irresponsible?
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 Posted Feb 21 2012 07:22AM
Jennifer, Thanks for the frank discussion on the FDA draft guidance. Very nicely written and one of the best pieces I have read on the draft guidance. I look forward to Phrma's input on the draft but I can imagine the direction it will take. I have found it somewhat difficult to understand the purpose of the guidance and its limits. After reading the draft, it caused me to wonder why the FDA would take so much time to issue such little guidance. Is there a message in the lack of message. Hopefully the final guidance will effectively incorporate the industry's feedback and provide additional direction on how we can use social media to advance the health and well being of patients through better communication.
 Posted Feb 22 2012 11:51AM
FDA first started looking at social media about 1997, so a first guidance 14 years later that doesn't answer important questions...speaks for itself. To provide further context, your readers might be interested in something I wrote this week in my blog, FDA Matters, wwww.fdamatters.com. I was responding to a reader who argued that EMA had been eager on biosimilars and FDA reluctant. My reply: "In less than two years, FDA has produced multiple policy speeches and articles, three guidances, held multiple sponsor meetings and allowed several sponsors to begin work. I assure you: FDA is fully committed to biosimilars! As an aside, anyone familiar with the lack of FDA guidance on product-related social media can tell you how FDA behaves when it is reluctant to act. It looks quite different." Yes, FDA and social media really is that bad!
 Posted Feb 29 2012 02:09AM
I understand the frustration which is being expressed by many of my colleagues in the industry. It would have been nice if the FDA provided greater clarity. However, I see this as a positive. Had the FDA provided greater guidance and provided it earlier, we may not have liked what was provided. I see this as a vote of confidence from the FDA. They have seen the industry act - and act in a responsible manner. They have seen groups like the Digital Health Coalition get formed and attempt to provide some cohesiveness around guidelines. Companies like AstraZeneca and SanofiAventis have developed and published guidelines just to name a few proactive companies. Webcina provided open access Social Media Guidelines for Pharma. Social Media is an area where the industry clearly has a level of comfort greater than the FDA - and the industry is acting responsibly. We just need to keep leading the FDA by responsible action - promoting better health, being transparent, etc. The consumer is speaking up as well - and supporting our active involvement. In a recent ePharma Consumer® study of 6,600 adults,they reported that 42 percent of online adults agree that pharmaceutical companies should be involved in online health communities for consumers. Additionally, only 19 percent of online adults disagree that pharma should participate in this type of forum - with the additional 39 percent being impartial to the issue. Let's take the opportunity to led by example sand responsible actions. Jack J Florio, CBO LiquidGrids
 Posted Mar 01 2012 02:15PM
Irresponsible? When I saw that adjective, I assumed people were referring to all the examples provided in the FDA guidance of “solicited requests for off-label information.” It’s a laundry list of pharma promo sins! But I disagree that the FDA is being “Irresponsible.” Yes, they are being slow, overly-cautious and not particularly helpful. But if anyone – pharma marketing execs or agency advisors or social media communities like Sermo – expects the FDA to publish a definitive list of DOs and DON’Ts, you’re going to be disappointed. There will be no “Social Media for Pharma” paint-by-numbers book that allows our clients to “color within the lines” and rest easy. Things change too fast, and each company will use various tools and channels in unique ways. Any “playbook” published during 2012 will be inadequate by mid-2013; the channel causing the most consternation in 2014 likely hasn’t even been invented yet. The ideal we can all hope for is a well-thought out, well-articulated philosophy about what pharma is responsible for when crafting its message when it doesn’t own/control the medium … or media … specifically social media! -- Rich Westelman, SVP - Sales & Client Services at Sermo
 
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