21st Century Prescription Drug Communications. Dale Cooke, President PhillyCooke

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1 21st Century Prescription Drug Communications Dale Cooke, President PhillyCooke

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4 of oncology patient encounters resulted in patients receiving unnecessary treatments

5 Shifting Media Consumption 45% 40% 35% 41% 37% % 25% 22% 23% 20% 18% 15% 15% 12% 10% 8% 7% 4% 4% 6% 5% 3% 2% 0% Print Radio TV Other Non- Desktop/Lapt Mobile Other Digital Digital op % 15% 41% 7% 22% 4% 4% % of time spent with each channel of all time spent with media per day % 12% emarketer October % 2% 18% 23% 6%

6 Shifting Media Consumption 45% 40% 35% % 37% All digital went from 30% to 47% 30% 25% 22% 23% 20% 18% 15% 15% 12% 10% 8% 7% 4% 4% 6% 5% 3% 2% 0% Print Radio TV Other Non- Desktop/Lapt Mobile Other Digital Digital op % 15% 41% 7% 22% 4% 4% % of time spent with each channel of all time spent with media per day % 12% emarketer October % 2% 18% 23% 6%

7 Shifting Media Consumption 45% 40% 35% 41% 37% Mobile exploded from 4% to 23% 30% 25% 22% 23% 20% 18% 15% 15% 12% 10% 8% 7% 4% 4% 6% 5% 3% 2% 0% Print Radio TV Other Non- Desktop/Lapt Mobile Other Digital Digital op % 15% 41% 7% 22% 4% 4% % of time spent with each channel of all time spent with media per day % 12% emarketer October % 2% 18% 23% 6%

8 Is it So-Mo or Mo-So? Minutes spent on social media Online 32 Mobile 35 Phone 20 Tablet 15 April 2014

9 Photo by Michael Coghlan via Flickr

10 1 in 5 minutes spent on mobile is spent on Facebook Photo by Michael Coghlan via Flickr comscore Mobile Metrix, US December 2014

11 Demography is destiny! 90% of millennials trust health information or engage in activities found via social media Social media "likes" healthcare, 2012

12 Doctors are people too! Photo by NEC-Medical-51 via Flickr

13 Doctors are people too! 56% of HCPS use social media for professional purposes Photo by NEC-Medical-51 via Flickr Physician Adoption of Social Media, June 2014

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15 Technology Changes Rapidly

16 FDA Regulation Doesn t FDA s social media guidance released in 2014 First official mention of Twitter in 2011 FDA still hasn t released any guidance on mobile promotion

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20 FDA Enabled Real-time Promotion Accepting monthly submissions to meet 2253 filing requirements Acknowledging User Generated Content s independence Abbreviated risk & indication statement Link to full risk information Meeting some promotional requirements via links Correcting misinformation outside promotional requirements

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24 A Video s Worth 100,000 Words

25 The World is Mobile

26 PhillyCooke.com

27 Speaker Bio: Dale Cooke Dale Cooke is the owner of PhillyCooke Consulting, which provides advice and training to companies about developing compliant promotional materials for FDA-regulated products. Dale has worked with more than 30 pharmaceutical and medical device clients around the world. His insights have been featured in the Wall Street Journal s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a Stronger FDA. He also serves on the faculty of the University of California San Francisco s American Course in Drug Development and Regulatory Sciences program. Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of FDLI s primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media. Previously, Dale served as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare Communications Group. Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University s School of Public Health and Healthcare Compliance at Seton Hall University s School of Law.