0
© 2013 Pharmaguy	

Overcoming Pharma’s Social
Media & Mobile Challenges
Bayer Pharma Meets
Pharmaguy Meets Startups
11 Jun...
© 2013 Pharmaguy	

Learn from Milestones & Mistakes
 Milestones – Important “firsts” have
paved the way for cautious foll...
© 2013 Pharmaguy	

 3	
  
Pharmaguy Has Been There (at FDA), Done This
 Testified as Panel Member at 1996 FDA
Hearing on ...
© 2013 Pharmaguy	

FDA Sends 14 Warning Letters
FDA sends 14 letters on a single day
to major pharmaceutical companies
con...
© 2013 Pharmaguy	

 5	
  
FDA Hosts Public Hearing
November 12-13, 2009
“This meeting and the written comments
are intende...
© 2013 Pharmaguy	

 6	
  
 "Miscellaneous Provision" of the "Food and
Drug Administration Safety and Innovation
Act" (aka...
© 2013 Pharmaguy	

Accountability
For what online communications are manufacturers, packers, or distributors accountable? ...
© 2013 Pharmaguy	

Accountability: Best Practices
  DISCLOSURE of involvement with or influence over 3rd-party social med...
© 2013 Pharmaguy	

Parameters for Correcting Misinformation
Are there any parameters or criteria that could be used to det...
© 2013 Pharmaguy	

Should Pharma Edit Drug Articles on Wikipedia?
10
© 2013 Pharmaguy	

 11
What challenges are presented in handling adverse event information from these sources?	

  The am...
© 2013 Pharmaguy	

“UCB has an ethical and legal responsibility to report adverse events associated
with our drugs. If adv...
© 2013 Pharmaguy	

 13
 13 June 2011: ABPI Pharmacovigilance Expert Network (PEN)
published “Guidance Notes” on managemen...
© 2013 Pharmaguy	

 14
December 27, 2011
 Section VI addresses responding to unsolicited
requests on public forums such a...
© 2013 Pharmaguy	

Pharma is Overcoming Social Media Hurdles
15
© 2013 Pharmaguy	

Pharma is Overcoming Social Media Hurdles
16
Period I: 54%
Period II: 30%
Period I: 24%
Period II: 42%
© 2013 Pharmaguy	

Sanofi-Aventis Vs. Patient on Facebook
17
March 15, 2010
The pharmaceutical industry’s
worst fear was r...
© 2013 Pharmaguy	

Sanofi Didn’t Give Up on Facebook
18
August 11, 2011
“Likes” have grown from 522 in January 2011 to ove...
© 2013 Pharmaguy	

I called this tweet
“Sleazy Twitter Spam”	

Challenge (US): How to fit
benefits and fair balance in 140...
© 2013 Pharmaguy	

First (& Last?) Live Pharma Twitter Chat
20
February 16, 2011
AstraZeneca hosted a one-hour chat on Twi...
© 2013 Pharmaguy	

 21
December 13, 2011
 The Prescription Medicines Code of Practice Authority
(PMCPA) ruled Allergan br...
© 2013 Pharmaguy	

 22	
  
 A promise to visitors of SM sites you own or sponsor about how
YOU will behave, not how you e...
© 2013 Pharmaguy	

What's Your Social Media Implementation Plan?
23
© 2013 Pharmaguy	

Is This the Typical Mobile Health App Developer
Hired by Pharma?
Easy entry into mHealth offers
incredi...
© 2013 Pharmaguy	

FDA Mobile Medical Apps “Scope of Oversight”
Pyramid
25	
  
© 2013 Pharmaguy	

An Obvious MMA Subject to FDA Regulation
26	
  
  uChek	
  Urine	
  analyzer,	
  which	
  is	
  
inten...
© 2013 Pharmaguy	

Undocumented & Untested(?) Pharma MMAs
27	
  
  Psoriasis	
  app	
  by	
  Janssen	
  includes	
  a	
  ...
© 2013 Pharmaguy	

The First Ever “Dear Doctor” Letter Regarding a
Mobile Medical App Recall
28	
  
  Pfizer	
  Rheumatolo...
© 2013 Pharmaguy	

More Mobile Health App Guidance from FDA for
Pharma to Worry About
29	
  
Standalone Clinical Decision ...
© 2013 Pharmaguy	

Reigning in the “Wild West” of Mobile Health Apps
30	
  
  Inaccurate	
  Health	
  Apps	
  
  Good	
 ...
© 2013 Pharmaguy	

Pharma Mobile Apps Survey Results
31	
  
© 2013 Pharmaguy	

More Survey Results
32	
  
How concerned are you that
current draft FDA regulatory
guidelines will inhi...
© 2013 Pharmaguy	

Self- Regulation of Pharma Mobile Health Apps
33	
  
  The	
  pharmaceu:cal	
  industry	
  must	
  pol...
© 2013 Pharmaguy	

 Social Media Pharma Marketing Readiness Self-Assessment --
http://bit.ly/SMreadiness
 Pharma Mobile ...
© 2013 Pharmaguy	

Thank You!	
  
35	
  
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Overcoming Pharma’s Social Media & Mobile Challenges

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This is a presentation I made at a Bayer HealthCare Grants4Apps™ meeting on June 11, 2013, in Berlin. It highlights some pharma social media and mobile app “milestones” or “firsts” that have paved the way for others to follow.

I identify the “Pioneers” who have helped the industry navigate through “uncharted” territory lacking regulatory guidance.

I also analyze some “mistakes” made by both leaders and followers. Only those who learn from thee mistakes of their competitors will move forward. Those who learn from their OWN mistakes will move forward fastest!

Finally, I present some ideas for “best practices” and “guiding principles” that may help you avoid regulatory actions.

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Transcript of "Overcoming Pharma’s Social Media & Mobile Challenges "

  1. 1. © 2013 Pharmaguy Overcoming Pharma’s Social Media & Mobile Challenges Bayer Pharma Meets Pharmaguy Meets Startups 11 June 2013 * Berlin, Germany
  2. 2. © 2013 Pharmaguy Learn from Milestones & Mistakes  Milestones – Important “firsts” have paved the way for cautious followers.  Mistakes – Best way to learn & benefit from your competition’s errors. “Constant Effort and Frequent Mistakes are the Stepping Stones to Genius” Elbert Hubbard, American writer 2  
  3. 3. © 2013 Pharmaguy 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  
  4. 4. © 2013 Pharmaguy FDA Sends 14 Warning Letters 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. April 2, 2009 4   1  April  2009:  Pharmaguy  posted   fake  “April  Fools”  press  release   announcing  publica;on  of  FDA   guidance  on  pharma’s  use  of   social  media.  
  5. 5. © 2013 Pharmaguy 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.”
  6. 6. © 2013 Pharmaguy 6    "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA)  “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.”     FDA's "Social Media Guidance Cliff" New Deadline is July 2014 As of 30 May 2013, no “actions completed” reported in FDASIA-TRACK
  7. 7. © 2013 Pharmaguy Accountability 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?   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)   When marketer or agent paid for the content (e.g., paid patients for testimonials or otherwise provided compensation)   When marketer or agent paid for display ads to be run on specific discussion pages (e.g., only discussions related to the product advertised) 3rd-Party Independence 7  
  8. 8. © 2013 Pharmaguy 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   Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should only be REQUIRED to do so only for sites owned or directly sponsored by them. 8  
  9. 9. © 2013 Pharmaguy Parameters for Correcting Misinformation Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?   ONLY misinformation of real and imminent danger to the public health (to be determined by company) should be corrected   ALL off-label claims—even if supported by peer-reviewed medical literature— should be corrected)   Only off-label claims NOT substantiated by peer-reviewed medical literature should be corrected   Companies should not be burdened by FDA regulations requiring them to make corrections about ANY product misinformation published on 3rd-party sites Posting Corrective Information 9  
  10. 10. © 2013 Pharmaguy Should Pharma Edit Drug Articles on Wikipedia? 10
  11. 11. © 2013 Pharmaguy 11 What challenges are presented in handling adverse event information from these sources?   The amount of information from these sources is potentially too vast to be processed economically (lack of resources)   Finding adverse event information from these sources is like finding a needle in a haystack (too daunting)   The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable)   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) Adverse Event Reporting Social Media Adverse Event Challenges
  12. 12. © 2013 Pharmaguy “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  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 12 UCB Embraces Adverse Events on Sponsored PatientsLikeMe Epilepsy Discussion Board June 16, 2009
  13. 13. © 2013 Pharmaguy 13  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) EU Online AE Reporting & Twitter Guidance
  14. 14. © 2013 Pharmaguy 14 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” FDA Off-Label Guidance & Social Media
  15. 15. © 2013 Pharmaguy Pharma is Overcoming Social Media Hurdles 15
  16. 16. © 2013 Pharmaguy Pharma is Overcoming Social Media Hurdles 16 Period I: 54% Period II: 30% Period I: 24% Period II: 42%
  17. 17. © 2013 Pharmaguy Sanofi-Aventis Vs. Patient on Facebook 17 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.
  18. 18. © 2013 Pharmaguy Sanofi Didn’t Give Up on Facebook 18 August 11, 2011 “Likes” have grown from 522 in January 2011 to over 6,700 in June 2013. “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.” Sanofi US Diabetes Won the 2012 Pharmaguy Social Media Pioneer Award
  19. 19. © 2013 Pharmaguy I called this tweet “Sleazy Twitter Spam” Challenge (US): How to fit benefits and fair balance in 140 characters or less? Challenge (Globally): How to make it meaningful for patients We’re Still Friends! 19 First (& Only?) Pharma Rx Branded Tweet! June 18, 2009
  20. 20. © 2013 Pharmaguy First (& Last?) Live Pharma Twitter Chat 20 February 16, 2011 AstraZeneca hosted a one-hour chat on Twitter to raise awareness about helping patients save money through prescription savings programs. Tony Jewell, AZ, won the 2011 Pharmaguy Social Media Pioneer Award
  21. 21. © 2013 Pharmaguy 21 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? Pharma Employee Tweet Problem
  22. 22. © 2013 Pharmaguy 22    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   Thoughts on an Outward-Facing SM Policy
  23. 23. © 2013 Pharmaguy What's Your Social Media Implementation Plan? 23
  24. 24. © 2013 Pharmaguy 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?” 24     Are  developers   knowledgeable  about   applicable  regula:ons,   laws,  and  pharma   sensibili:es?  
  25. 25. © 2013 Pharmaguy FDA Mobile Medical Apps “Scope of Oversight” Pyramid 25  
  26. 26. © 2013 Pharmaguy An Obvious MMA Subject to FDA Regulation 26     uChek  Urine  analyzer,  which  is   intended  for  use  with  reagent   strips  (e.g.,  Bayer  Dias:x)  for  the   qualita:ve  determina:on  of   urine  analytes  including  glucose,   urobilinogen,  pH,  ketone,  blood,   protein,  bilirubin,  nitrite,   leukocyte,  and  specific  gravity.         Company  received  “It  Has  Come   to  Our  APen:on”  lePer  from  the   FDA  reques:ng  a  “clearance   number.  
  27. 27. © 2013 Pharmaguy Undocumented & Untested(?) Pharma MMAs 27     Psoriasis  app  by  Janssen  includes  a   “PASI”  (Psoriasis  Area  and  Severity   Index)    calculator     No  cita:on  of  source  used  to  perform   calcula:on  –  was  it  the  equa:on  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  cer:fied  by  a   third-­‐party?     Is  this  an  “MMA”  subject  to  FDA   regula:on?  
  28. 28. © 2013 Pharmaguy The First Ever “Dear Doctor” Letter Regarding a Mobile Medical App Recall 28     Pfizer  Rheumatology  Calculator     Most  downloaded  app  tracked   by  POCKET.MD  (5-­‐Star  user   ra:ng)     Recalled  via  a  “Dear  Doctor”   LePer  in  October  2011  because   of  "a  bug  in  the  app  ...  gives   wrong  results.”  
  29. 29. © 2013 Pharmaguy More Mobile Health App Guidance from FDA for Pharma to Worry About 29   Standalone Clinical Decision Support (CDS)
  30. 30. © 2013 Pharmaguy Reigning in the “Wild West” of Mobile Health Apps 30     Inaccurate  Health  Apps     Good  App  Privacy  Prac:ces     Test  and  Document     Cer:fica:on  of  Mobile  Health   Apps     Industry  Self-­‐Regula:on  
  31. 31. © 2013 Pharmaguy Pharma Mobile Apps Survey Results 31  
  32. 32. © 2013 Pharmaguy More Survey Results 32   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   prac:ces  or  self-­‐ regulatory  guidelines    
  33. 33. © 2013 Pharmaguy Self- Regulation of Pharma Mobile Health Apps 33     The  pharmaceu:cal  industry  must  police  itself  with   regard  to  development  of  medical  apps;  e.g.,  Issue   “Guidelines  for  Mobile  Health  Apps  Developed  by   the  Pharmaceu:cal  Industry.”  Some  suggested   guidelines,  include:       Apps  should  cite  the  source  of  the  data  used  by  the  app  and   include  contact  informa:on  for  repor:ng  errors.  Call  this  a   “Mobile  App  Adverse  Event  Repor:ng  &  Tracking”  system.     Apps  must  be  rigorously  tested  &  cer:fied  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.  
  34. 34. © 2013 Pharmaguy  Social Media Pharma Marketing Readiness Self-Assessment -- http://bit.ly/SMreadiness  Pharma Mobile Health App Best Practices Survey -- http://bit.ly/ByMobile  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! Resources   34  
  35. 35. © 2013 Pharmaguy Thank You!   35  
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