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Pharma, Social Media, & Mobile A Happy Ménage à Trois?

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A presentation I made at the Third Annual Pharma eMarketing Congress in Barcelona on 11 September 2013.

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Pharma, Social Media, & Mobile A Happy Ménage à Trois?

  1. 1. Pharma, Social Media, & Mobile A Happy Ménage à Trois? 3rd Annual Pharma eMarketing Congress 11- 13 Sept 2013 * Barcelona, Spain © 2013 Pharmaguy
  2. 2. Learn from Milestones & Mistakes “Constant Effort and Frequent Mistakes are the Stepping Stones to Genius” Elbert Hubbard, American writer Milestones – Important “firsts” have paved the way for cautious followers. Mistakes – Best way to learn & benefit from your competition’s errors. © 2013 Pharmaguy 2
  3. 3. Pharmaguy Has Been There (at FDA), Done This Testified as Panel Member at 1996 FDA Hearing on Internet Co-Founded Internet Healthcare Coalition (1997) Co-Authored the eHealth Code of Ethics (2000) Blogged About Pharmaceutical Digital Marketing Practices Since 2005 Presented Survey Results at the 2009 FDA Hearing on Social Media © 2013 Pharmaguy 3
  4. 4. FDA Sends 14 Warning Letters April 2, 2009 FDA sends 14 letters on a single day to major pharmaceutical companies concerning their Google and Yahoo Rx paid search ads. Letters were dated 29 March 2009, but made public on 2 April 2009. 1 April 2009: Pharmaguy posted fake “April Fools” press release announcing publication of FDA guidance on pharma’s use of social media. © 2013 Pharmaguy 4
  5. 5. FDA Hosts Public Hearing November 12-13, 2009 “This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.” April 2, 2009: Pharmaguy issued first public call for FDA public hearing on social media. “We should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.” © 2013 Pharmaguy 5
  6. 6. FDA's "Social Media Guidance Cliff" New Deadline is July 2014  "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA) As of 30 May 2013, no “actions completed” reported in FDASIA-TRACK © 2013 Pharmaguy  “Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.” 6
  7. 7. Q: When is Pharma Accountable for Information on 3rd-Party Social Media Sites? For what online communications are manufacturers, packers, or distributors accountable? In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products? A. When marketer or agent sponsors the discussion (e.g., provides a specific grant to independent 3rd-party host such as a patient advocacy group to sponsor the discussion) B. When marketer or agent paid for the content (e.g., paid patients for testimonials or otherwise provided compensation) C. When marketer or agent paid for display ads to be run on specific discussion pages (e.g., only discussions related to the product advertised) © 2013 Pharmaguy 7
  8. 8. Accountability Survey Results © 2013 Pharmaguy 8
  9. 9. Accountability: Best Practices  DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible. Half of survey respondents agree  Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.] About two-thirds of survey respondents agree © 2013 Pharmaguy 9
  10. 10. Q: Should Pharma Edit Drug Articles on Wikipedia? When is it appropriate for pharma companies to edit Wikipedia articles that include "misinformation" about their drugs? A. Never B. Always C. Depends © 2013 Pharmaguy 10
  11. 11. Appropriate Wikipedia Editing Practices © 2013 Pharmaguy 11
  12. 12. Q: What Are the Challenges in Handling AEs? What challenges are presented in handling adverse event information from social media sources? A. The amount of information from these sources is potentially too vast to be processed economically (lack of resources) B. Finding adverse event information from these sources is like finding a needle in a haystack (too daunting) C. The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable) D. There are many potential issues that won't fully be known until the practice of monitoring social media for AEs is more prevalent (unknown issues) © 2013 Pharmaguy 12
  13. 13. Social Media Adverse Event Survey Results © 2013 Pharmaguy 13
  14. 14. UCB Embraces Adverse Events on Sponsored PatientsLikeMe Epilepsy Discussion Board June 16, 2009  Goal: Generate patient-reported outcomes that may help UCB better understand how patients live with epilepsy and help advance epilepsy care.  Provides disease tracking tools  Deployed a system for reporting adverse events to FDA “UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” -- Peter Verdru, MD, UCB‟s Vice President of Clinical Research © 2013 Pharmaguy 14
  15. 15. EU Online AE Reporting & Twitter Guidance  13 June 2011: ABPI Pharmacovigilance Expert Network (PEN) published “Guidance Notes” on management of AEs on pharma owned/sponsored Websites; AEs should be collected and documented, regardless of seriousness of event and whether or not there is an identifiable reporter (http://bit.ly/BritAEguide)  1 April 2011: PMCPA issued “informal guidance” for applying its Code to social media; e.g., communication with physicians via Twitter, corrections to Wikipedia, appropriate use of metadata (http://bit.ly/PMBBritsvFDA) © 2013 Pharmaguy 15
  16. 16. FDA Off-Label Guidance & Social Media December 27, 2011  Section VI addresses responding to unsolicited requests on public forums such as the Internet and "emerging electronic media”  Cites cases on YouTube, blogs, and Twitter: Pharma should respond to unsolicited requests via private channels  “FDA recommends that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information” © 2013 Pharmaguy 16
  17. 17. Pharma is Overcoming Social Media Hurdles © 2013 Pharmaguy 17
  18. 18. Pharma is Overcoming Social Media Hurdles Period I: 24% Period II: 42% Period I: 54% Period II: 30% © 2013 Pharmaguy 18
  19. 19. Sanofi-Aventis Vs. Patient on Facebook March 15, 2010 The pharmaceutical industry’s worst fear was realized when a “disgruntled patient” posted multiple adverse event messages and photos on the wall of a Sanofi-Aventis Facebook page (VOICES). The page did not have comments turned off and did not include any terms of use. © 2013 Pharmaguy 19
  20. 20. Sanofi US Diabetes Won the 2012 Pharmaguy Social Media Pioneer Award Sanofi Didn’t Give Up on Facebook August 11, 2011 “Since we operate in a heavily regulated industry, we… must preview all messages.” “While some messages may not be posted, we are listening and encourage you to continue sharing.” “Likes” have grown from 522 in January 2011 to over 6,700 in June 2013. © 2013 Pharmaguy 20
  21. 21. First (& Only?) Pharma Rx Branded Tweet! June 18, 2009 I called this tweet “Sleazy Twitter Spam” We’re Still Friends! © 2013 Pharmaguy Challenge (US): How to fit benefits and fair balance in 140 characters or less? Challenge (Globally): How to make it meaningful for patients 21
  22. 22. Tony Jewell, AZ, won the 2011 Pharmaguy Social Media Pioneer Award First Live Pharma TweetChat February 16, 2011 AstraZeneca hosted a one-hour chat on Twitter to raise awareness about helping patients save money through prescription savings programs. © 2013 Pharmaguy 22
  23. 23. Pharma’s First Disease Condition TweetChats September 2 and 9, 2013 Boehringer Ingelheim hosted a live #COPDChat TweetChat at the European Respiratory Society 2013 Congress to “discuss the latest 'hot topics' in #COPD with leading experts. We'll be chatting about the role of dual bronchodilation in COPD, discussing whether there is a need for new treatment options and whether digital COPD tools can improve patient care and disease outcomes. NonUS/UK participants only. BI also hosted #ChatAFib, a live TweetChat event which took place on 2 September 2013 during #ESCCongress2013. The participants discussed cardiovascular disease and thrombosis in women. © 2013 Pharmaguy 23
  24. 24. Pharma Employee Tweet Problem December 13, 2011  The Prescription Medicines Code of Practice Authority (PMCPA) ruled Allergan breached the Code on several counts after an employee accidentally tweeted publicly about Botox  Employee violated Allergan’s "Global Social Media Policy” that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity."  Should pharmacos make their SM policies public to be more transparent & accountable? © 2013 Pharmaguy 24
  25. 25. Thoughts on an Outward-Facing SM Policy  A promise to visitors of SM sites you own or sponsor about how YOU will behave, not how you expect THEM to behave  Think of it as serving a similar purpose as your privacy policy  Includes: Your comment moderation policy; this requires more details than what has been seen to date Rules for participation by your employees (reflects the internal policy that your employees are trained on) Rules for participation by agents of your company (should be same as apply to your employees; trained on also) Other “rules of engagement”; e.g., correction of misinformation © 2013 Pharmaguy 25
  26. 26. What's Your Social Media Implementation Plan? © 2013 Pharmaguy 26
  27. 27. End of Part 1 Any QUESTIONS? © 2013 Pharmaguy 27
  28. 28. Reigning in the “Wild West” of Mobile Health Apps     Inaccurate Health Apps Good App Privacy Practices Test and Document Certification of Mobile Health Apps  Industry Self-Regulation © 2013 Pharmaguy 28
  29. 29. Is This the Typical Mobile Health App Developer Hired by Pharma? Easy entry into mHealth offers incredible opportunity for innovation in healthcare; however, the open market comes with certain concerns, namely, “how credible are the apps I am (or my patients are) using?”  Are developers knowledgeable about applicable regulations, laws, and pharma sensibilities? © 2013 Pharmaguy 29
  30. 30. FDA Mobile Medical Apps “Scope of Oversight” Pyramid © 2013 Pharmaguy 30
  31. 31. Q: Is This App an MMA Subject to FDA Regulation?  uChek Urine analyzer, which is intended for use with reagent strips (e.g., Bayer Diastix) for the qualitative determination of urine analytes including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity. A. Yes B. No C. I Don’t Know © 2013 Pharmaguy 31
  32. 32. Undocumented & Untested(?) Pharma MMAs  Psoriasis app by Janssen includes a “PASI” (Psoriasis Area and Severity Index) calculator  No citation of source used to perform calculation – was it the equation above?  No disclaimer such as "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein.”  Was the app tested and certified by a third-party?  Is this an “MMA” subject to FDA regulation? © 2013 Pharmaguy 32
  33. 33. The First Ever “Dear Doctor” Letter Regarding a Mobile Medical App Recall  Pfizer Rheumatology Calculator  Most downloaded app tracked by POCKET.MD (5-Star user rating)  Recalled via a “Dear Doctor” Letter in October 2011 because of "a bug in the app ... gives wrong results.” © 2013 Pharmaguy 33
  34. 34. More Mobile Health App Guidance from FDA for Pharma to Worry About Standalone Clinical Decision Support (CDS) © 2013 Pharmaguy 34
  35. 35. Pharma Mobile Health App Best Practices Survey © 2013 Pharmaguy 35
  36. 36. Q: Will Mobile App Regulations Stifle Innovation? How concerned are you that current draft FDA regulatory guidelines will inhibit pharma companies from developing mobile health apps for consumers and physicians? A. Concerned B. Not Concerned C. Neutral © 2013 Pharmaguy 36
  37. 37. More Survey Results How concerned are you that current draft FDA regulatory guidelines will inhibit pharma companies from developing mobile health apps for consumers and physicians?  77% agree that it is in the drug industry's best interest to police itself and develop best practices or selfregulatory guidelines © 2013 Pharmaguy 37
  38. 38. Self- Regulation of Pharma Mobile Medical Apps  The pharmaceutical industry must police itself with regard to development of medical apps; e.g., Issue “Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry.” Some suggested guidelines, include:  Apps should cite the source of the data used by the app and include contact information for reporting errors. Call this a “Mobile App Adverse Event Reporting & Tracking” system.  Apps must be rigorously tested & certified by a third-party to ensure quality and accuracy.  Apps should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run. © 2013 Pharmaguy 38
  39. 39. Resources  Social Media Pharma Marketing Readiness Self-Assessment -http://bit.ly/SMreadiness  Pharma Mobile Health App Best Practices Survey -http://bit.ly/MobileBPsurvey  Overcoming Space Limitations in Social Media; http://bit.ly/fdasmSpace Use code „FDA397‟ to get it FREE!  Accountability for Pharma Content on Social Media Sites; http://bit.ly/fdasmAcct Use code „FDA497‟ to get it FREE!  Solving the Social Media Adverse Event Reporting Problem; http://bit.ly/fdasmAE Use code „AE495‟ to get it FREE!  Pharma is Overcoming Social Media Hurdles: Assessing the Three Biggest Obstacles to Success; http://bit.ly/SMhurdles Use code „SMhurdleFREE‟ to get it FREE! © 2013 Pharmaguy 39
  40. 40. Thank You! © 2013 Pharmaguy 40

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