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Thank	
  you	
  for	
  invi.ng	
  me	
  speak	
  at	
  the	
  Roche	
  Digital	
  Academy!	
  
Unfortunately,	
  I	
  will	
  have	
  to	
  speak	
  rapidly	
  in	
  English	
  to	
  get	
  through	
  all	
  
my	
  slides	
  in	
  the	
  alloAed	
  .me,	
  but	
  I	
  am	
  sure	
  you	
  will	
  get	
  a	
  copy	
  of	
  my	
  
slides	
  –	
  including	
  my	
  notes	
  –	
  to	
  read	
  at	
  your	
  leisure	
  aDerward.	
  
I	
  this	
  presenta.on,	
  I	
  will	
  show	
  you	
  some	
  pharma	
  social	
  media	
  
“milestones”	
  or	
  “firsts”	
  that	
  have	
  paved	
  the	
  way	
  for	
  others	
  to	
  follow.	
  	
  
I	
  will	
  iden.fy	
  the	
  “Pioneers”	
  who	
  have	
  helped	
  the	
  industry	
  navigate	
  
through	
  “uncharted”	
  territory	
  lacking	
  regulatory	
  guidance.	
  
I	
  will	
  also	
  show	
  you	
  some	
  “mistakes”	
  made	
  by	
  both	
  leaders	
  and	
  
followers.	
  Only	
  those	
  who	
  learn	
  from	
  thee	
  mistakes	
  of	
  their	
  compe.tors	
  
will	
  move	
  forward.	
  Those	
  who	
  learn	
  from	
  their	
  OWN	
  mistakes	
  will	
  move	
  
forward	
  fastest!	
  
Finally,	
  I	
  will	
  present	
  some	
  ideas	
  for	
  “best	
  prac.ces”	
  and	
  “guiding	
  
principles”	
  that	
  may	
  help	
  you	
  avoid	
  regulatory	
  ac.ons.	
  
	
  
The	
  dic.onary	
  defines	
  "aficionado"	
  as	
  a	
  “person	
  who	
  is	
  very	
  
knowledgeable	
  and	
  enthusias.c	
  about	
  an	
  ac.vity,	
  subject,	
  or	
  pas.me.”	
  	
  
I	
  have	
  been	
  around	
  for	
  a	
  quite	
  some	
  .me	
  and	
  have	
  first-­‐hand	
  experience	
  
with	
  government	
  regulatory	
  and	
  voluntary	
  industry	
  codes	
  of	
  prac.ce.	
  
Studying	
  digital	
  pharma	
  has	
  been	
  my	
  “pas.me”	
  for	
  many	
  years.	
  But	
  I	
  
don’t	
  just	
  study	
  digital	
  pharma,	
  I	
  document	
  and	
  try	
  to	
  INFLUENCE	
  it,	
  as	
  
you	
  will	
  see	
  in	
  the	
  following	
  slides.	
  
	
  
FDA’s	
  famous	
  14	
  leAers	
  alerted	
  pharma	
  to	
  the	
  fact	
  that	
  the	
  agency	
  is	
  
now	
  looking	
  carefully	
  at	
  how	
  the	
  industry	
  promotes	
  its	
  products	
  via	
  the	
  
Internet.	
  	
  
I	
  pushed	
  this	
  issue	
  in	
  December	
  2006	
  when	
  I	
  blogged	
  that	
  “FDA	
  should	
  
be	
  taking	
  a	
  closer	
  look	
  at	
  drug	
  promo.on	
  via	
  the	
  Internet.”	
  	
  
And	
  the	
  .ming	
  of	
  my	
  2009	
  April	
  Fools’	
  joke	
  was	
  perfect	
  –	
  many	
  pharma	
  
people	
  were	
  primed	
  to	
  believe	
  the	
  FDA	
  actually	
  came	
  out	
  with	
  digital	
  
guidance	
  and	
  several	
  were	
  angry	
  at	
  me	
  for	
  playing	
  such	
  a	
  cruel	
  joke!	
  
The	
  14	
  leAers	
  took	
  aim	
  squarely	
  at	
  the	
  so-­‐called	
  “one-­‐click	
  rule”	
  which	
  
was	
  not	
  a	
  rule	
  at	
  all	
  –	
  it	
  was	
  just	
  what	
  pharma	
  people	
  wanted	
  to	
  believe	
  
and	
  were	
  lead	
  to	
  believe	
  by	
  FDA’s	
  inac.on	
  prior	
  to	
  the	
  14	
  leAers.	
  In	
  
fact,	
  I	
  warned	
  the	
  industry	
  about	
  the	
  invalidity	
  of	
  this	
  “rule”	
  or	
  
“received	
  wisdom”	
  as	
  far	
  back	
  as	
  November,	
  2006,	
  when	
  I	
  debated	
  it	
  at	
  
an	
  industry	
  conference.	
  Alas,	
  only	
  someone	
  outside	
  the	
  industry	
  could	
  
see	
  that	
  the	
  Emperor	
  had	
  no	
  clothes!	
  
I’d	
  like	
  to	
  believe	
  that	
  my	
  call	
  for	
  public	
  hearings	
  back	
  in	
  April	
  2009,	
  
mo.vated	
  the	
  FDA	
  to	
  act.	
  Unfortunately,	
  however,	
  the	
  hearings	
  were	
  
has.ly	
  organized	
  and	
  as	
  a	
  result,	
  they	
  did	
  not	
  include	
  ALL	
  stakeholders	
  
as	
  I	
  urged.	
  Consumer	
  advocates	
  were	
  missing	
  and	
  agencies	
  and	
  industry	
  
service	
  providers	
  dominated	
  the	
  speaker	
  roster.	
  Rela.ve	
  to	
  the	
  1996	
  
hearing,	
  few	
  pharma	
  companies	
  made	
  presenta.ons	
  at	
  the	
  2009	
  
hearing.	
  
This	
  shirt	
  appeared	
  in	
  my	
  presenta.on	
  to	
  the	
  FDA	
  at	
  the	
  November	
  
hearings!	
  It	
  was	
  my	
  way	
  of	
  predic.ng	
  the	
  outcome.	
  	
  
Congress	
  put	
  some	
  language	
  in	
  in	
  recent	
  legisla.on	
  that	
  requires	
  the	
  FDA	
  
to	
  issue	
  social	
  media	
  guidance	
  by	
  July	
  2014.	
  	
  
Does	
  that	
  mean	
  the	
  FDA	
  will	
  deliver?	
  If	
  not,	
  it	
  wouldn't	
  be	
  the	
  first	
  .me	
  
that	
  a	
  government	
  agency	
  missed	
  deadlines	
  imposed	
  by	
  Congress.	
  
I	
  call	
  this	
  FDA's	
  "Social	
  Media	
  Guidance	
  Cliff.”	
  
FDA	
  Safety	
  and	
  Innova.on	
  Act	
  (FDASIA)-­‐TRACK	
  must	
  include	
  the	
  
deliverables	
  with	
  statutory	
  dates,	
  as	
  well	
  as	
  other	
  tasks	
  required	
  to	
  
implement	
  the	
  law.	
  
To	
  date,	
  no	
  “other	
  tasks”	
  for	
  SM	
  guidance	
  have	
  been	
  entered	
  in	
  the	
  
database.	
  	
  
Why	
  the	
  delay?	
  Perhaps	
  the	
  industry	
  wants	
  legally	
  binding	
  regula.ons,	
  not	
  
guidance.	
  Pfizer,	
  for	
  example,	
  contends	
  that	
  FDA’s	
  proposed	
  social	
  media	
  
guidance	
  “raises	
  First	
  Amendment	
  concerns.”	
  Guidance,	
  said	
  Pfizer,	
  is	
  too	
  
vague	
  and	
  engenders	
  “extensive	
  [First	
  Amendment]	
  li.ga.on.”	
  
	
  
	
  
	
  
Over	
  the	
  2011	
  Christmas	
  holidays,	
  while	
  most	
  of	
  us	
  were	
  s.ll	
  on	
  vaca.on,	
  
the	
  FDA	
  quietly	
  issued	
  without	
  fanfare	
  "Guidance	
  for	
  Industry	
  Responding	
  
to	
  Unsolicited	
  Requests	
  for	
  Off-­‐Label	
  Informa.on	
  About	
  Prescrip.on	
  Drugs	
  
and	
  Medical	
  Devices."	
  	
  
Sec.on	
  VI.	
  of	
  this	
  guidance	
  addresses	
  responding	
  to	
  unsolicited	
  requests	
  
on	
  public	
  forums	
  such	
  as	
  the	
  Internet.	
  While	
  this	
  may	
  not	
  be	
  the	
  "social	
  
media"	
  guidance	
  many	
  people	
  were	
  expec.ng,	
  it	
  does	
  include	
  guidelines	
  
for	
  responding	
  to	
  unsolicited	
  requests	
  for	
  off-­‐label	
  informa.on	
  
encountered	
  through	
  "emerging	
  electronic	
  media.”	
  
The	
  primary	
  take-­‐away	
  is	
  that	
  such	
  requests	
  NOT	
  be	
  handled	
  by	
  sales	
  or	
  
marke.ng	
  people	
  and	
  that	
  responses	
  should	
  be	
  via	
  private	
  channels	
  not	
  
via	
  open	
  forums	
  such	
  as	
  on	
  Youtube,	
  blogs,	
  and	
  TwiAer.	
  
	
  
	
  
As	
  soon	
  as	
  the	
  FDA	
  issued	
  the	
  public	
  no.ce	
  about	
  the	
  hearings	
  and	
  
posted	
  19	
  ques.ons	
  it	
  was	
  seeking	
  to	
  answer,	
  I	
  hosted	
  a	
  survey	
  that	
  
asked	
  my	
  readers	
  to	
  respond	
  to	
  those	
  same	
  19	
  ques.ons.	
  
FDA	
  asked	
  “Open-­‐Ended”	
  ques.ons.	
  My	
  survey	
  asked	
  respondents	
  to	
  
vote	
  on	
  specific	
  op.ons	
  as	
  well	
  as	
  including	
  comment	
  boxes.	
  	
  
I	
  submiAed	
  the	
  complete	
  survey	
  results	
  to	
  the	
  FDA	
  docket	
  and	
  
summarized	
  the	
  results	
  in	
  my	
  presenta.ons	
  at	
  the	
  hearing.	
  The	
  following	
  
slides	
  also	
  summarize	
  some	
  results	
  from	
  that	
  survey	
  as	
  well	
  as	
  comments	
  
submiAed	
  to	
  the	
  docket	
  by	
  major	
  pharma	
  companies.	
  
FDA	
  asked	
  “Open-­‐Ended”	
  ques.ons.	
  My	
  survey	
  asked	
  respondents	
  to	
  
vote	
  on	
  specific	
  op.ons	
  as	
  well	
  as	
  including	
  open-­‐comment	
  boxes.	
  	
  
Regarding	
  accountability,	
  the	
  survey	
  wanted	
  to	
  compare	
  situa.ons	
  
where	
  pharma	
  paid	
  for	
  content,	
  provided	
  grants	
  for	
  independent	
  
content,	
  or	
  sponsored	
  branded	
  ads	
  that	
  targeted	
  specific	
  3rd-­‐party	
  
content.	
  	
  
Another	
  survey	
  I	
  hosted	
  asked	
  slightly	
  different	
  ques.ons	
  in	
  an	
  
aAempt	
  to	
  define	
  some	
  “best	
  prac.ces”	
  regarding	
  disclosures	
  and	
  
accountability.	
  
One	
  “best	
  prac.ce”	
  that	
  I’d	
  like	
  to	
  see	
  more	
  companies	
  prac.ce	
  is	
  a	
  
Public	
  Social	
  Media	
  Policy	
  that	
  includes	
  a	
  no.ce	
  of	
  its	
  transparency/
disclosure	
  and	
  other	
  policies	
  rela.ng	
  to	
  social	
  media.	
  About	
  two-­‐thirds	
  
of	
  survey	
  respondents	
  agree	
  with	
  me!	
  
I	
  know	
  of	
  only	
  one	
  company	
  that	
  has	
  a	
  public	
  social	
  media	
  policy.	
  That	
  
company	
  is	
  Roche.	
  
Comments	
  submiAed	
  to	
  the	
  FDA	
  docket	
  by	
  the	
  drug	
  industry	
  allow	
  us	
  
to	
  learn	
  more	
  about	
  what	
  the	
  industry	
  considers	
  to	
  be	
  best	
  social	
  
media	
  prac.ces	
  and	
  where	
  it	
  believes	
  the	
  regulatory	
  boundaries	
  are.	
  
Not	
  all	
  pharma	
  companies,	
  however,	
  agree	
  on	
  defini.ons	
  or	
  where	
  to	
  
draw	
  the	
  boundaries.	
  
Back	
  to	
  my	
  survey.	
  
How	
  pharma	
  corrects	
  or	
  allows	
  misinforma.on	
  to	
  be	
  posted	
  on	
  social	
  
media	
  sites	
  it	
  controls	
  is	
  an	
  important	
  part	
  of	
  its	
  social	
  media	
  policy	
  
that	
  should	
  be	
  revealed	
  to	
  visitors	
  of	
  such	
  sites.	
  
Nearly	
  a	
  majority	
  of	
  pharma	
  respondents	
  would	
  not	
  like	
  to	
  see	
  FDA	
  
mandate	
  that	
  they	
  correct	
  misinforma.on	
  about	
  products	
  on	
  3rd-­‐party	
  
sites,	
  although	
  about	
  one-­‐fiDh	
  think	
  misinforma.on	
  of	
  real	
  and	
  
imminent	
  danger	
  to	
  the	
  public	
  health	
  (to	
  be	
  determined	
  by	
  company)	
  
should	
  be	
  corrected.	
  
One	
  important	
  3rd-­‐party	
  site	
  where	
  misinforma.on	
  about	
  drugs	
  may	
  be	
  
found	
  is	
  Wikipedia.	
  
“If	
  you	
  want	
  your	
  customers	
  to	
  access	
  informa.on	
  about	
  your	
  products	
  
from	
  the	
  quality	
  perspec.ve	
  and	
  in	
  the	
  simplest	
  way,	
  you	
  have	
  to	
  deal	
  with	
  
using	
  Wikipedia,”	
  said	
  Dr.	
  Bertalan	
  Meskó	
  (@Berci).	
  
Berci,	
  however,	
  did	
  not	
  mean	
  that	
  pharma	
  companies	
  should	
  secretly	
  and	
  
selec.vely	
  alter	
  informa.on	
  as	
  in	
  this	
  example:	
  	
  
In	
  July	
  of	
  2007,	
  employees	
  of	
  AbboA	
  Laboratories	
  altered	
  entries	
  to	
  
Wikipedia	
  to	
  eliminate	
  informa.on	
  about	
  a	
  Mayo	
  Clinic	
  study	
  that	
  revealed	
  
that	
  pa.ents	
  taking	
  the	
  arthri.s	
  drug	
  Humira	
  faced	
  triple	
  the	
  risk	
  of	
  
developing	
  certain	
  kinds	
  of	
  cancers	
  and	
  twice	
  the	
  risk	
  of	
  developing	
  serious	
  
infec.ons.	
  
I	
  hosted	
  another	
  survey	
  asking	
  respondents	
  under	
  what	
  circumstances	
  
should	
  pharma	
  edit	
  drug	
  ar.cles	
  on	
  Wikipedia.	
  Based	
  on	
  this.	
  The	
  best	
  
prac.ce	
  is	
  to	
  appoint	
  an	
  “official”	
  Wikipedia	
  editor	
  as	
  recommended	
  by	
  
Berci	
  and	
  ensure	
  that	
  editors	
  reveal	
  .es	
  to	
  companies.	
  	
  Although	
  a	
  
substan.al	
  minority	
  of	
  respondents	
  feel	
  that	
  FDA	
  should	
  regulate	
  pharma	
  
edits	
  to	
  Wikipedia	
  drug	
  ar.cles,	
  in	
  comments	
  submiAed	
  to	
  the	
  FDA	
  docket,	
  
PhRMA	
  suggested	
  that	
  manufacturers	
  would	
  welcome	
  correc.ng	
  
misinforma.on	
  about	
  their	
  products	
  posted	
  to	
  3rd-­‐party	
  sites	
  such	
  as	
  	
  
14
According	
  to	
  my	
  survey,	
  the	
  vast	
  majority	
  –	
  83%	
  –	
  of	
  pharma	
  
respondents	
  think	
  it	
  is	
  impossible	
  to	
  adequately	
  handle	
  AEs	
  from	
  social	
  
media	
  sources.	
  “It's	
  remarkable	
  how	
  very	
  liAle	
  we	
  see	
  that	
  meets	
  the	
  
criteria	
  of	
  an	
  adverse	
  event,”	
  said	
  one	
  pharma	
  respondent.	
  The	
  criteria	
  
referred	
  to	
  are	
  these:	
  an	
  iden.fiable	
  pa.ent,	
  a	
  specific	
  medica.on,	
  an	
  
iden.fiable	
  reporter	
  and	
  a	
  reac.on.	
  
The	
  “iden.fiable	
  reporter”	
  is	
  the	
  most	
  difficult	
  bit	
  of	
  “required”	
  
informa.on	
  to	
  obtain.	
  “Many	
  people	
  use	
  the	
  Internet	
  to	
  share	
  
informa.on	
  and	
  remain	
  anonymous	
  when	
  doing	
  so,	
  even	
  if	
  an	
  email	
  
address	
  or	
  other	
  personal	
  (excluding	
  a	
  name)	
  is	
  provided,”	
  noted	
  PhRMA	
  
in	
  its	
  comments	
  to	
  the	
  FDA.	
  “Unless	
  people	
  opt-­‐in	
  to	
  say	
  they	
  want	
  their	
  
informa.on	
  to	
  be	
  shared	
  with	
  pharmaceu.cal	
  (or	
  other)	
  companies,	
  
these	
  companies	
  should	
  not	
  pursue	
  contac.ng	
  a	
  person	
  if	
  an	
  AE	
  is	
  
reported.	
  While	
  not	
  everyone	
  understands	
  that	
  AEs	
  can	
  be	
  reported	
  
directly	
  to	
  the	
  FDA	
  or	
  a	
  company,	
  there	
  needs	
  to	
  be	
  more	
  emphasis	
  to	
  
consumers	
  about	
  how	
  they	
  should/can	
  report	
  AEs	
  so	
  that	
  companies	
  are	
  
not	
  liable	
  for	
  what	
  they	
  "happen"	
  to	
  find	
  online.”	
  
In	
  light	
  of	
  all	
  the	
  emphasis	
  US	
  pharma	
  companies	
  place	
  on	
  “iden.fiable	
  
reporter,”	
  it	
  is	
  	
  interes.ng	
  that	
  ABPI	
  (UK)	
  advised	
  its	
  members	
  that	
  “AEs	
  
should	
  be	
  collected	
  and	
  documented,	
  regardless	
  of	
  seriousness	
  of	
  event	
  
and	
  whether	
  or	
  not	
  there	
  is	
  an	
  iden.fiable	
  reporter”	
  (see	
  SLIDE	
  #	
  X).	
  
Pharma	
  companies	
  had	
  some	
  sugges.ons	
  for	
  how	
  FDA	
  could	
  help	
  the	
  
industry	
  deal	
  with	
  online	
  adverse	
  event	
  reports.	
  
Meanwhile,	
  some	
  companies	
  are	
  sexng	
  the	
  “Gold	
  Standard”	
  for	
  managing	
  
online	
  adverse	
  event	
  reports	
  and	
  deploying	
  the	
  necessary	
  resources	
  to	
  make	
  
it	
  possible.	
  
The	
  Associa.on	
  of	
  the	
  Bri.sh	
  Pharmaceu.cal	
  Industry	
  has	
  also	
  come	
  out	
  
with	
  specific	
  guidelines	
  for	
  managing	
  adverse	
  events	
  on	
  pharma	
  owned	
  or	
  
sponsored	
  Web	
  sites.	
  Interes.ngly,	
  the	
  guidelines	
  ignore	
  the	
  “iden.fiable	
  
reporter”	
  condi.on	
  required	
  by	
  the	
  FDA	
  for	
  an	
  AE	
  to	
  be	
  “reportable.”	
  
The	
  Brits	
  have	
  also	
  issued	
  some	
  guidance	
  for	
  using	
  TwiAer	
  to	
  communicate	
  
with	
  physicians,	
  making	
  correc.ons	
  to	
  Wikipedia	
  –	
  an	
  issue	
  discussed	
  in	
  a	
  
previous	
  slide	
  –	
  and	
  appropriate	
  use	
  of	
  metadata.	
  	
  
You	
  can	
  find	
  details	
  by	
  following	
  the	
  links	
  given.	
  
Despite	
  the	
  lack	
  of	
  FDA	
  guidance,	
  pharmaceu.cal	
  marketers	
  have	
  come	
  a	
  
long	
  way	
  in	
  integra.ng	
  social	
  media	
  into	
  their	
  overall	
  marke.ng	
  strategy.	
  
These	
  are	
  data	
  from	
  the	
  Social	
  Media	
  Readiness	
  survey	
  tool	
  I	
  have	
  been	
  
running	
  since	
  December,	
  2007.	
  Over	
  300	
  marketers	
  working	
  for	
  drug	
  or	
  
device	
  companies	
  have	
  taken	
  the	
  survey.	
  The	
  survey	
  asks	
  ques.ons	
  to	
  
evaluate	
  readiness	
  in	
  three	
  categories:	
  regulatory	
  (e.g.,	
  aversion	
  of	
  risk),	
  
culture	
  (e.g.,	
  sensi.vity	
  to	
  cri.cism),	
  and	
  personal	
  experience.	
  Scores	
  are	
  
calculated.	
  This	
  compares	
  scores	
  prior	
  to	
  July,	
  2009,	
  with	
  scores	
  aDerward.	
  
Not	
  every	
  pharma	
  company,	
  however,	
  is	
  at	
  the	
  same	
  point	
  in	
  the	
  adop.on	
  
curve.	
  Some	
  are	
  more	
  willing	
  to	
  take	
  "risks,"	
  some	
  are	
  more	
  savvy	
  about	
  
applicable	
  FDA	
  regula.ons,	
  and	
  some	
  are	
  more	
  knowledgeable	
  about	
  
social	
  media	
  in	
  general.	
  	
  
Let’s	
  see	
  how	
  Roche	
  did.	
  
20
These	
  results,	
  of	
  course,	
  are	
  based	
  on	
  a	
  very	
  small	
  number	
  of	
  responses.	
  
It	
  seems,	
  however,	
  that	
  Roche	
  employees	
  feel	
  that	
  the	
  company	
  is	
  savvy	
  
regarding	
  the	
  regulatory	
  issues	
  rela.ng	
  to	
  social	
  media	
  but	
  lacks	
  the	
  type	
  
of	
  culture	
  required	
  to	
  be	
  comfortable	
  with	
  making	
  social	
  media	
  mistakes.	
  
If	
  you	
  have	
  not	
  taken	
  the	
  survey,	
  please	
  do.	
  I	
  can	
  report	
  back	
  updated	
  
results	
  aDerward.	
  	
  
21
Let’s	
  look	
  at	
  more	
  detail	
  regarding	
  how	
  pharma	
  employees	
  rate	
  their	
  
companies’	
  readiness	
  to	
  deal	
  with	
  social	
  media	
  readiness	
  issues.	
  
You	
  can	
  see	
  that	
  in	
  the	
  early	
  period	
  prior	
  to	
  July	
  2009,	
  the	
  majority	
  of	
  
respondents	
  thought	
  their	
  companies	
  had	
  a	
  “very	
  cau.ous”	
  regulatory	
  
climate	
  with	
  only	
  24%	
  saying	
  the	
  climate	
  was	
  “very	
  aggressive.”	
  Theses	
  
days,	
  it	
  seems	
  from	
  these	
  results,	
  pharma	
  companies	
  are	
  seen	
  as	
  much	
  
less	
  cau.ous	
  and	
  more	
  aggressive.	
  
I	
  guess	
  that	
  is	
  due	
  to	
  the	
  lack	
  of	
  significant	
  FDA	
  “warning”	
  leAers	
  being	
  
sent	
  that	
  involve	
  social	
  media.	
  In	
  other	
  words,	
  the	
  “received	
  wisdom”	
  is	
  
that	
  pharma	
  companies	
  are	
  nego.a.ng	
  the	
  social	
  media	
  regulatory	
  
challenges	
  without	
  specific	
  guidance	
  from	
  the	
  FDA.	
  
Be	
  careful	
  though!	
  The	
  FDA	
  hammer	
  may	
  fall	
  again	
  just	
  as	
  it	
  did	
  the	
  day	
  
aDer	
  April	
  Fools’	
  Day	
  in	
  2009.	
  
22
While	
  pharma	
  may	
  be	
  gexng	
  more	
  comfortable	
  engaging	
  in	
  social	
  media	
  
without	
  FDA	
  guidance,	
  there	
  has	
  been	
  some	
  retrenchment	
  in	
  adop.ng	
  
social	
  media	
  for	
  marke.ng.	
  
For	
  example,	
  there	
  are	
  fewer	
  pharma	
  Facebook	
  pages	
  today	
  than	
  there	
  
were	
  prior	
  to	
  August	
  15,	
  2011,	
  when	
  Facebook	
  changed	
  its	
  policy	
  on	
  
comments.	
  ADer	
  the	
  change,	
  which	
  did	
  not	
  allow	
  pharma	
  companies	
  to	
  
turn	
  off	
  comments	
  to	
  their	
  Facebook	
  pages,	
  many	
  companies	
  just	
  shut	
  
down	
  their	
  pages.	
  
"This	
  new	
  policy	
  will	
  alter	
  our	
  ability	
  to	
  consider	
  the	
  appropriateness	
  of	
  
comments	
  before	
  they	
  are	
  posted	
  which	
  is	
  important	
  to	
  us	
  as	
  a	
  company	
  
in	
  a	
  highly	
  regulated	
  industry,”	
  said	
  McNeil	
  Pediatrics	
  when	
  it	
  shut	
  down	
  
its	
  ADHD	
  Moms	
  page.	
  	
  
An	
  example	
  of	
  this	
  was	
  the	
  shutdown	
  of	
  the	
  Psoriasis	
  Facebook	
  page	
  by	
  
Janssen	
  Pharmaceu.cals.	
  This	
  page	
  –	
  launched	
  in	
  October,	
  2010	
  –	
  was	
  the	
  
first	
  pharma	
  Facebook	
  page	
  that	
  published	
  comments	
  BEFORE	
  reviewing	
  
but	
  reserved	
  the	
  right	
  to	
  delete	
  them	
  aDerward.	
  
Janssen	
  cited	
  its	
  inability	
  to	
  moderate	
  posts	
  made	
  to	
  the	
  Psoriasis	
  360	
  	
  
wall,	
  one-­‐third	
  of	
  which	
  "men.on[ed]	
  a	
  specific	
  drug	
  by	
  name,	
  or	
  talk[ed]	
  
about	
  the	
  efficacy	
  of	
  a	
  par.cular	
  treatment	
  is	
  (or	
  its	
  side	
  effects)."	
  In	
  such	
  
cases,	
  Janssen	
  had	
  to	
  ask	
  for	
  the	
  post	
  to	
  be	
  removed	
  or	
  to	
  "pull"	
  it.	
  	
  
Perhaps	
  this	
  decision	
  represents	
  a	
  lack	
  of	
  commitment	
  aDer	
  Alex	
  Butler,	
  
former	
  Janssen	
  Digital	
  Strategy	
  and	
  Social	
  Media	
  Manager,	
  leD	
  the	
  
company.	
  Alex	
  was	
  the	
  person	
  responsible	
  for	
  Psoriasis	
  360.	
  For	
  his	
  
efforts,	
  I	
  awarded	
  him	
  the	
  first	
  ever	
  Pharmaguy	
  Social	
  Media	
  Pioneer	
  
award.	
  
Another	
  example	
  was	
  the	
  shutdown	
  of	
  the	
  ADHD	
  Moms	
  Facebook	
  page	
  
by	
  McNeil	
  Pediatrics.	
  This	
  was	
  the	
  first	
  pharma	
  Facebook	
  page	
  –	
  launched	
  
in	
  June,	
  2008.	
  
"This	
  new	
  policy	
  will	
  alter	
  our	
  ability	
  to	
  consider	
  the	
  appropriateness	
  of	
  
comments	
  before	
  they	
  are	
  posted	
  which	
  is	
  important	
  to	
  us	
  as	
  a	
  company	
  
in	
  a	
  highly	
  regulated	
  industry,”	
  said	
  McNeil.	
  
	
  
There	
  were	
  examples	
  of	
  pharma-­‐owned	
  or	
  sponsored	
  open	
  discussion	
  
boards	
  even	
  before	
  Facebook	
  became	
  popular.	
  GSK’s	
  Ques.onEverything,	
  
which	
  was	
  launched	
  in	
  April,	
  2006,	
  is	
  an	
  example.	
  It	
  allowed	
  comments	
  
from	
  consumers	
  and	
  posted	
  them	
  aDer	
  review	
  (“pre-­‐modera.on”).	
  
This	
  site	
  is	
  no	
  longer	
  available.	
  
Pre-­‐modera.on	
  –	
  where	
  possible	
  –	
  may	
  be	
  the	
  best	
  prac.ce	
  for	
  pharma	
  
social	
  media	
  sites,	
  including	
  YouTube.	
  
However,	
  these	
  days,	
  very	
  few	
  pharma	
  companies	
  allow	
  any	
  comments	
  at	
  
all,	
  which	
  is	
  a	
  shame	
  because	
  	
  that	
  is	
  the	
  best	
  way	
  to	
  build	
  community	
  and	
  
aAract	
  more	
  viewers	
  
Of	
  course,	
  there	
  is	
  good	
  reason	
  why	
  pharma	
  companies	
  fear	
  comments	
  on	
  
Facebook	
  as	
  this	
  case	
  demonstrates.	
  
However,	
  this	
  could	
  have	
  been	
  prevented:	
  
•  Problem	
  #1:	
  No	
  one	
  at	
  S-­‐A	
  was	
  monitoring	
  this	
  site	
  or	
  seemed	
  to	
  be	
  
responsible	
  for	
  it.	
  
•  Problem	
  #2:	
  There	
  was	
  no	
  policy	
  in	
  place	
  for	
  what	
  cons.tutes	
  
acceptable	
  comments	
  and	
  how	
  comments	
  would	
  be	
  moderated	
  or	
  
deleted.	
  
•  Problem	
  #3:	
  There	
  was	
  no	
  social	
  media	
  “crisis	
  management	
  plan”	
  other	
  
than	
  “remove	
  all	
  comments!”	
  
	
  
Sanofi	
  learned	
  from	
  its	
  mistakes	
  and	
  even	
  spoke	
  about	
  them	
  in	
  a	
  public	
  
forum;	
  i.e.,	
  my	
  Pharma	
  Marke.ng	
  Talk	
  show	
  .tled:	
  “What	
  Sanofi-­‐Aven.s	
  
Learned	
  from	
  Its	
  FaceBook	
  Experience	
  &	
  What	
  the	
  Experts	
  Recommend	
  It	
  
Do	
  Now.”	
  In	
  that	
  show	
  I	
  interviewed	
  	
  Dennis	
  Urbaniak,	
  VP	
  U.S.	
  Diabetes.	
  	
  
Listen	
  to	
  the	
  podcast:	
  hAp://bit.ly/PMT098	
  	
  
The	
  Sanofi	
  US	
  Diabetes	
  team	
  won	
  the	
  third	
  (2012)	
  Pharmagy	
  Social	
  Media	
  
Pioneer	
  Award.	
  
	
  
Even	
  the	
  biggest	
  pharma	
  company	
  in	
  the	
  world	
  can	
  be	
  humbled	
  by	
  
Facebook	
  backlash.	
  In	
  this	
  case,	
  it	
  was	
  Pfizer	
  and	
  the	
  product	
  is	
  not	
  
regulated	
  by	
  the	
  FDA.	
  Nevertheless,	
  it	
  illustrates	
  how	
  important	
  it	
  is	
  to	
  
pay	
  aAen.on	
  to	
  what’s	
  going	
  on	
  in	
  the	
  social	
  media	
  spaces	
  that	
  you	
  own	
  
and	
  to	
  have	
  a	
  “crisis	
  plan”	
  in	
  place.	
  
The	
  issue	
  was	
  this:	
  Pfizer	
  selec.vely	
  deleted	
  “nega.ve”	
  comments	
  in	
  an	
  
aAempt	
  to	
  control	
  the	
  discussion.	
  
What’s	
  the	
  lesson?	
  
You	
  are	
  NOT	
  in	
  control	
  of	
  the	
  discussion	
  on	
  social	
  media.	
  
This	
  is	
  pharma’s	
  major	
  social	
  media	
  conundrum:	
  	
  
(1)  pharma	
  marketers	
  are	
  used	
  to	
  controlling	
  the	
  discussion	
  (or	
  not	
  having	
  
a	
  discussion	
  at	
  all),	
  and	
  	
  
(2)  pharma	
  marketers	
  are	
  legally	
  responsible	
  for	
  the	
  content	
  of	
  the	
  
discussions	
  on	
  sites	
  they	
  own.	
  
Although	
  Pfizer	
  got	
  into	
  trouble	
  with	
  comments	
  on	
  Facebook,	
  it	
  did	
  not	
  
shrink	
  from	
  allowing	
  comments	
  on	
  other	
  social	
  media	
  sites	
  like	
  its	
  “Get	
  
Old”	
  community.	
  
On	
  June	
  18,	
  2012,	
  Pfizer	
  launched	
  "Get	
  Old,"	
  a	
  mul.-­‐year	
  ini.a.ve	
  
supported	
  by	
  nearly	
  a	
  dozen	
  advocacy	
  organiza.ons.	
  	
  
Registered	
  users	
  can	
  post	
  links,	
  videos,	
  photos,	
  or	
  stories	
  (including	
  
comments	
  up	
  to	
  1000	
  characters)	
  to	
  the	
  site.	
  You	
  can	
  even	
  submit	
  
comments	
  to	
  other	
  posts	
  and	
  "Like,"	
  tweet,	
  or	
  email	
  comments.	
  Every	
  
comment	
  submiAed	
  is	
  reviewed	
  before	
  being	
  uploaded	
  -­‐	
  a	
  process	
  that	
  is	
  
completed	
  within	
  48	
  hours.	
  
Pfizer	
  says	
  it	
  has	
  a	
  social	
  media	
  “Playbook,”	
  according	
  to	
  Ray	
  Kerins,	
  
Pfizer’s	
  former	
  Vice	
  President	
  of	
  Worldwide	
  Communica.ons.	
  “While	
  I	
  
don't	
  want	
  to	
  say	
  it's	
  proprietary,”	
  said	
  Kerins,	
  “I	
  also	
  don't	
  want	
  to	
  make	
  
too	
  big	
  of	
  a	
  deal	
  about	
  it	
  because	
  we	
  call	
  it	
  common	
  sense.”	
  
In	
  the	
  U.S.,	
  of	
  course,	
  direct-­‐to-­‐consumer	
  branded	
  drug	
  adver.sing	
  is	
  
permissible,	
  but	
  is	
  it	
  always	
  necessary?	
  
I	
  cri.cized	
  this	
  tweet	
  as	
  “sleazy	
  twiAer	
  spam”	
  because	
  I	
  did	
  not	
  follow	
  
this	
  account	
  to	
  receive	
  branded	
  messages	
  but	
  to	
  learn	
  more	
  about	
  
how	
  the	
  celebrity	
  racecar	
  driver	
  Charlie	
  Kimball	
  coped	
  with	
  managing	
  
his	
  diabetes	
  while	
  racing.	
  	
  
Although	
  the	
  adver.sed	
  product	
  is	
  part	
  of	
  the	
  story,	
  this	
  tweet	
  had	
  no	
  
educa.onal	
  value	
  and	
  was	
  merely	
  a	
  “product	
  placement”	
  or	
  
“reminder”	
  type	
  of	
  ad	
  that	
  PhRMA	
  says	
  should	
  not	
  be	
  used	
  –	
  at	
  least	
  
on	
  TV.	
  But	
  if	
  it’s	
  not	
  OK	
  for	
  TV,	
  it	
  should	
  also	
  not	
  be	
  OK	
  for	
  social	
  
media.	
  
Anyway,	
  Novo	
  Nordisk	
  par.cipated	
  in	
  open	
  discussion	
  about	
  this	
  and	
  
learned	
  –	
  I	
  haven’t	
  seen	
  any	
  other	
  tweets	
  like	
  this	
  since.	
  
Listen	
  to	
  this	
  Pharma	
  Marke.ng	
  Talk	
  	
  podcast:	
  “Novo	
  Nordisk's	
  Race	
  
With	
  Insulin	
  Campaign:	
  It's	
  Not	
  Just	
  About	
  TwiAer”	
  	
  
hAp://bit.ly/PMTalk087	
  	
  
Back	
  in	
  November,	
  2011,	
  I	
  asked	
  “Will	
  a	
  Pharma	
  Company	
  Ever	
  Host	
  a	
  
Chat	
  on	
  TwiAer?”	
  (hAp://bit.ly/Twchat).	
  I	
  answered	
  my	
  own	
  ques.on	
  
with:	
  “most	
  pharma	
  companies	
  may	
  never	
  directly	
  host	
  or	
  moderate	
  
TwiAer	
  chats	
  because	
  they	
  can	
  control	
  neither	
  the	
  audience	
  nor	
  the	
  
message.”	
  
So,	
  I	
  was	
  surprised	
  when	
  Astrazeneca	
  hosted	
  the	
  first	
  live	
  TwiAer	
  chat	
  
session	
  on	
  February	
  16,	
  2011.	
  	
  
Despite	
  dire	
  predic.ons	
  of	
  "PR	
  failure,"	
  the	
  chat	
  was	
  a	
  great	
  success	
  and	
  
proof	
  that	
  a	
  pharmaceu.cal	
  company	
  can	
  indeed	
  host	
  meaningful	
  TwiAer	
  
chats.	
  
There	
  were	
  a	
  few	
  aAempts	
  by	
  two	
  or	
  three	
  "malcontents"	
  to	
  "hijack"	
  the	
  
conversa.on.	
  These	
  people	
  made	
  the	
  most	
  tweets	
  that	
  included	
  the	
  
#rxsave	
  hash	
  tag,	
  but	
  despite	
  their	
  aAempts	
  to	
  ask	
  "the	
  tough	
  ques.ons"	
  
about	
  off-­‐label	
  promo.on	
  of	
  drugs	
  and	
  Seroquel	
  side	
  effects,	
  everyone	
  
completely	
  ignored	
  the	
  hijackers	
  and	
  the	
  conversa.on	
  con.nued	
  as	
  if	
  
these	
  people	
  were	
  not	
  even	
  there.	
  
Tony	
  Jewell	
  (@tonyjewell),	
  Senior	
  Director	
  of	
  External	
  Communica.ons	
  at	
  
AstraZeneca	
  US,	
  received	
  the	
  2nd	
  Pharmaguy	
  Social	
  Media	
  Pioneer	
  award	
  
for	
  his	
  pioneering	
  use	
  of	
  TwiAer.	
  
It	
  is	
  one	
  thing	
  to	
  host	
  a	
  TwiAer	
  chat	
  where	
  you	
  can	
  control	
  what	
  is	
  
being	
  posted	
  by	
  your	
  representa.ve(s)	
  as	
  part	
  of	
  that	
  chat.	
  But	
  it	
  is	
  
quite	
  another	
  problem	
  controlling	
  unauthorized	
  tweets	
  made	
  by	
  
employees	
  without	
  the	
  knowledge	
  of	
  your	
  MLR	
  people	
  as	
  this	
  case	
  
illustrates.	
  
A	
  “Global	
  Social	
  Media	
  Policy”	
  doesn’t	
  mean	
  much	
  unless	
  
•  It	
  is	
  publicly	
  available	
  so	
  the	
  company	
  can	
  be	
  held	
  accountable	
  in	
  a	
  
transparent	
  fashion,	
  and	
  
•  Employees	
  are	
  trained	
  in	
  the	
  policy,	
  which	
  should	
  include	
  sanc.ons	
  
such	
  as	
  dismissal	
  for	
  viola.on	
  of	
  the	
  policy.	
  
Having	
  social	
  media	
  principles	
  that	
  guide	
  how	
  your	
  employees	
  use	
  
social	
  media	
  and	
  interact	
  with	
  the	
  public	
  online	
  is	
  a	
  good	
  first	
  step.	
  But	
  
if	
  they	
  are	
  to	
  have	
  any	
  effect,	
  employees	
  must	
  be	
  TRAINED	
  to	
  
understand	
  how	
  to	
  apply	
  the	
  principles	
  in	
  the	
  real	
  world.	
  And,	
  as	
  with	
  
privacy	
  policies,	
  the	
  fact	
  that	
  employees	
  receive	
  this	
  training	
  should	
  be	
  
stated	
  in	
  the	
  outward-­‐facing	
  social	
  media	
  policy	
  that	
  the	
  company	
  
publishes.	
  
These	
  are	
  just	
  a	
  few	
  of	
  my	
  “half-­‐baked”	
  ideas	
  pertaining	
  to	
  a	
  public	
  
social	
  media	
  policy	
  for	
  pharmaceu.cal	
  companies	
  to	
  adopt.	
  
Roche	
  is	
  the	
  only	
  pharmaceu.cal	
  company	
  that	
  has	
  publicly	
  disclosed	
  
its	
  social	
  media	
  principles.	
  Bravo!	
  
	
  
In	
  closing,	
  I	
  would	
  like	
  to	
  emphasize	
  that	
  to	
  implement	
  a	
  strategy	
  for	
  
using	
  social	
  media	
  as	
  part	
  of	
  your	
  marke.ng	
  campaigns,	
  it	
  is	
  important	
  
to	
  have	
  a	
  plan.	
  But	
  what	
  are	
  the	
  ac.on	
  items	
  for	
  implemen.ng	
  your	
  
plan?	
  	
  
This	
  survey	
  asked	
  respondents	
  to	
  indicate	
  how	
  important	
  the	
  following	
  
ac.on	
  items	
  are	
  in	
  implemen.ng	
  a	
  social	
  media	
  plan:	
  
•  #1:	
  Get	
  everyone	
  -­‐	
  including	
  marke.ng,	
  regulatory	
  people,	
  corporate	
  
communica.ons,	
  C-­‐level	
  execs	
  -­‐	
  on	
  board	
  
•  #2:	
  Become	
  a	
  dialogue	
  company	
  -­‐	
  learn	
  how	
  to	
  listen	
  and	
  respond,	
  not	
  just	
  
push	
  messages	
  out	
  
•  #3:	
  Have	
  a	
  sustained	
  vision/goal	
  
•  #4:	
  Train	
  people	
  who	
  will	
  be	
  interac.ng	
  directly	
  with	
  consumers	
  
•  Create	
  a	
  social	
  media	
  Tsar	
  posi.on	
  to	
  oversee	
  all	
  the	
  company's	
  SM	
  projects	
  
to	
  assure	
  compliance	
  with	
  guidelines	
  
•  Develop	
  a	
  modera.on	
  strategy	
  
•  Develop	
  guideposts,	
  internal	
  and	
  external	
  standard	
  opera.ng	
  procedures	
  
•  Marshall	
  necessary	
  resources	
  -­‐	
  use	
  the	
  best	
  tools	
  available	
  
•  Unblock	
  corporate	
  access	
  to	
  social	
  media	
  so	
  employees	
  can	
  monitor	
  and	
  
use	
  applica.ons	
  such	
  as	
  Facebook	
  while	
  at	
  work	
  
35
Overcoming Pharma’s Social Media Challenges
Overcoming Pharma’s Social Media Challenges

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Overcoming Pharma’s Social Media Challenges

  • 1. Thank  you  for  invi.ng  me  speak  at  the  Roche  Digital  Academy!   Unfortunately,  I  will  have  to  speak  rapidly  in  English  to  get  through  all   my  slides  in  the  alloAed  .me,  but  I  am  sure  you  will  get  a  copy  of  my   slides  –  including  my  notes  –  to  read  at  your  leisure  aDerward.  
  • 2. I  this  presenta.on,  I  will  show  you  some  pharma  social  media   “milestones”  or  “firsts”  that  have  paved  the  way  for  others  to  follow.     I  will  iden.fy  the  “Pioneers”  who  have  helped  the  industry  navigate   through  “uncharted”  territory  lacking  regulatory  guidance.   I  will  also  show  you  some  “mistakes”  made  by  both  leaders  and   followers.  Only  those  who  learn  from  thee  mistakes  of  their  compe.tors   will  move  forward.  Those  who  learn  from  their  OWN  mistakes  will  move   forward  fastest!   Finally,  I  will  present  some  ideas  for  “best  prac.ces”  and  “guiding   principles”  that  may  help  you  avoid  regulatory  ac.ons.    
  • 3. The  dic.onary  defines  "aficionado"  as  a  “person  who  is  very   knowledgeable  and  enthusias.c  about  an  ac.vity,  subject,  or  pas.me.”     I  have  been  around  for  a  quite  some  .me  and  have  first-­‐hand  experience   with  government  regulatory  and  voluntary  industry  codes  of  prac.ce.   Studying  digital  pharma  has  been  my  “pas.me”  for  many  years.  But  I   don’t  just  study  digital  pharma,  I  document  and  try  to  INFLUENCE  it,  as   you  will  see  in  the  following  slides.    
  • 4. FDA’s  famous  14  leAers  alerted  pharma  to  the  fact  that  the  agency  is   now  looking  carefully  at  how  the  industry  promotes  its  products  via  the   Internet.     I  pushed  this  issue  in  December  2006  when  I  blogged  that  “FDA  should   be  taking  a  closer  look  at  drug  promo.on  via  the  Internet.”     And  the  .ming  of  my  2009  April  Fools’  joke  was  perfect  –  many  pharma   people  were  primed  to  believe  the  FDA  actually  came  out  with  digital   guidance  and  several  were  angry  at  me  for  playing  such  a  cruel  joke!  
  • 5. The  14  leAers  took  aim  squarely  at  the  so-­‐called  “one-­‐click  rule”  which   was  not  a  rule  at  all  –  it  was  just  what  pharma  people  wanted  to  believe   and  were  lead  to  believe  by  FDA’s  inac.on  prior  to  the  14  leAers.  In   fact,  I  warned  the  industry  about  the  invalidity  of  this  “rule”  or   “received  wisdom”  as  far  back  as  November,  2006,  when  I  debated  it  at   an  industry  conference.  Alas,  only  someone  outside  the  industry  could   see  that  the  Emperor  had  no  clothes!  
  • 6. I’d  like  to  believe  that  my  call  for  public  hearings  back  in  April  2009,   mo.vated  the  FDA  to  act.  Unfortunately,  however,  the  hearings  were   has.ly  organized  and  as  a  result,  they  did  not  include  ALL  stakeholders   as  I  urged.  Consumer  advocates  were  missing  and  agencies  and  industry   service  providers  dominated  the  speaker  roster.  Rela.ve  to  the  1996   hearing,  few  pharma  companies  made  presenta.ons  at  the  2009   hearing.   This  shirt  appeared  in  my  presenta.on  to  the  FDA  at  the  November   hearings!  It  was  my  way  of  predic.ng  the  outcome.    
  • 7. Congress  put  some  language  in  in  recent  legisla.on  that  requires  the  FDA   to  issue  social  media  guidance  by  July  2014.     Does  that  mean  the  FDA  will  deliver?  If  not,  it  wouldn't  be  the  first  .me   that  a  government  agency  missed  deadlines  imposed  by  Congress.   I  call  this  FDA's  "Social  Media  Guidance  Cliff.”   FDA  Safety  and  Innova.on  Act  (FDASIA)-­‐TRACK  must  include  the   deliverables  with  statutory  dates,  as  well  as  other  tasks  required  to   implement  the  law.   To  date,  no  “other  tasks”  for  SM  guidance  have  been  entered  in  the   database.     Why  the  delay?  Perhaps  the  industry  wants  legally  binding  regula.ons,  not   guidance.  Pfizer,  for  example,  contends  that  FDA’s  proposed  social  media   guidance  “raises  First  Amendment  concerns.”  Guidance,  said  Pfizer,  is  too   vague  and  engenders  “extensive  [First  Amendment]  li.ga.on.”        
  • 8. Over  the  2011  Christmas  holidays,  while  most  of  us  were  s.ll  on  vaca.on,   the  FDA  quietly  issued  without  fanfare  "Guidance  for  Industry  Responding   to  Unsolicited  Requests  for  Off-­‐Label  Informa.on  About  Prescrip.on  Drugs   and  Medical  Devices."     Sec.on  VI.  of  this  guidance  addresses  responding  to  unsolicited  requests   on  public  forums  such  as  the  Internet.  While  this  may  not  be  the  "social   media"  guidance  many  people  were  expec.ng,  it  does  include  guidelines   for  responding  to  unsolicited  requests  for  off-­‐label  informa.on   encountered  through  "emerging  electronic  media.”   The  primary  take-­‐away  is  that  such  requests  NOT  be  handled  by  sales  or   marke.ng  people  and  that  responses  should  be  via  private  channels  not   via  open  forums  such  as  on  Youtube,  blogs,  and  TwiAer.      
  • 9. As  soon  as  the  FDA  issued  the  public  no.ce  about  the  hearings  and   posted  19  ques.ons  it  was  seeking  to  answer,  I  hosted  a  survey  that   asked  my  readers  to  respond  to  those  same  19  ques.ons.   FDA  asked  “Open-­‐Ended”  ques.ons.  My  survey  asked  respondents  to   vote  on  specific  op.ons  as  well  as  including  comment  boxes.     I  submiAed  the  complete  survey  results  to  the  FDA  docket  and   summarized  the  results  in  my  presenta.ons  at  the  hearing.  The  following   slides  also  summarize  some  results  from  that  survey  as  well  as  comments   submiAed  to  the  docket  by  major  pharma  companies.  
  • 10. FDA  asked  “Open-­‐Ended”  ques.ons.  My  survey  asked  respondents  to   vote  on  specific  op.ons  as  well  as  including  open-­‐comment  boxes.     Regarding  accountability,  the  survey  wanted  to  compare  situa.ons   where  pharma  paid  for  content,  provided  grants  for  independent   content,  or  sponsored  branded  ads  that  targeted  specific  3rd-­‐party   content.    
  • 11. Another  survey  I  hosted  asked  slightly  different  ques.ons  in  an   aAempt  to  define  some  “best  prac.ces”  regarding  disclosures  and   accountability.   One  “best  prac.ce”  that  I’d  like  to  see  more  companies  prac.ce  is  a   Public  Social  Media  Policy  that  includes  a  no.ce  of  its  transparency/ disclosure  and  other  policies  rela.ng  to  social  media.  About  two-­‐thirds   of  survey  respondents  agree  with  me!   I  know  of  only  one  company  that  has  a  public  social  media  policy.  That   company  is  Roche.  
  • 12. Comments  submiAed  to  the  FDA  docket  by  the  drug  industry  allow  us   to  learn  more  about  what  the  industry  considers  to  be  best  social   media  prac.ces  and  where  it  believes  the  regulatory  boundaries  are.   Not  all  pharma  companies,  however,  agree  on  defini.ons  or  where  to   draw  the  boundaries.  
  • 13. Back  to  my  survey.   How  pharma  corrects  or  allows  misinforma.on  to  be  posted  on  social   media  sites  it  controls  is  an  important  part  of  its  social  media  policy   that  should  be  revealed  to  visitors  of  such  sites.   Nearly  a  majority  of  pharma  respondents  would  not  like  to  see  FDA   mandate  that  they  correct  misinforma.on  about  products  on  3rd-­‐party   sites,  although  about  one-­‐fiDh  think  misinforma.on  of  real  and   imminent  danger  to  the  public  health  (to  be  determined  by  company)   should  be  corrected.  
  • 14. One  important  3rd-­‐party  site  where  misinforma.on  about  drugs  may  be   found  is  Wikipedia.   “If  you  want  your  customers  to  access  informa.on  about  your  products   from  the  quality  perspec.ve  and  in  the  simplest  way,  you  have  to  deal  with   using  Wikipedia,”  said  Dr.  Bertalan  Meskó  (@Berci).   Berci,  however,  did  not  mean  that  pharma  companies  should  secretly  and   selec.vely  alter  informa.on  as  in  this  example:     In  July  of  2007,  employees  of  AbboA  Laboratories  altered  entries  to   Wikipedia  to  eliminate  informa.on  about  a  Mayo  Clinic  study  that  revealed   that  pa.ents  taking  the  arthri.s  drug  Humira  faced  triple  the  risk  of   developing  certain  kinds  of  cancers  and  twice  the  risk  of  developing  serious   infec.ons.   I  hosted  another  survey  asking  respondents  under  what  circumstances   should  pharma  edit  drug  ar.cles  on  Wikipedia.  Based  on  this.  The  best   prac.ce  is  to  appoint  an  “official”  Wikipedia  editor  as  recommended  by   Berci  and  ensure  that  editors  reveal  .es  to  companies.    Although  a   substan.al  minority  of  respondents  feel  that  FDA  should  regulate  pharma   edits  to  Wikipedia  drug  ar.cles,  in  comments  submiAed  to  the  FDA  docket,   PhRMA  suggested  that  manufacturers  would  welcome  correc.ng   misinforma.on  about  their  products  posted  to  3rd-­‐party  sites  such  as     14
  • 15. According  to  my  survey,  the  vast  majority  –  83%  –  of  pharma   respondents  think  it  is  impossible  to  adequately  handle  AEs  from  social   media  sources.  “It's  remarkable  how  very  liAle  we  see  that  meets  the   criteria  of  an  adverse  event,”  said  one  pharma  respondent.  The  criteria   referred  to  are  these:  an  iden.fiable  pa.ent,  a  specific  medica.on,  an   iden.fiable  reporter  and  a  reac.on.  
  • 16. The  “iden.fiable  reporter”  is  the  most  difficult  bit  of  “required”   informa.on  to  obtain.  “Many  people  use  the  Internet  to  share   informa.on  and  remain  anonymous  when  doing  so,  even  if  an  email   address  or  other  personal  (excluding  a  name)  is  provided,”  noted  PhRMA   in  its  comments  to  the  FDA.  “Unless  people  opt-­‐in  to  say  they  want  their   informa.on  to  be  shared  with  pharmaceu.cal  (or  other)  companies,   these  companies  should  not  pursue  contac.ng  a  person  if  an  AE  is   reported.  While  not  everyone  understands  that  AEs  can  be  reported   directly  to  the  FDA  or  a  company,  there  needs  to  be  more  emphasis  to   consumers  about  how  they  should/can  report  AEs  so  that  companies  are   not  liable  for  what  they  "happen"  to  find  online.”   In  light  of  all  the  emphasis  US  pharma  companies  place  on  “iden.fiable   reporter,”  it  is    interes.ng  that  ABPI  (UK)  advised  its  members  that  “AEs   should  be  collected  and  documented,  regardless  of  seriousness  of  event   and  whether  or  not  there  is  an  iden.fiable  reporter”  (see  SLIDE  #  X).  
  • 17. Pharma  companies  had  some  sugges.ons  for  how  FDA  could  help  the   industry  deal  with  online  adverse  event  reports.  
  • 18. Meanwhile,  some  companies  are  sexng  the  “Gold  Standard”  for  managing   online  adverse  event  reports  and  deploying  the  necessary  resources  to  make   it  possible.  
  • 19. The  Associa.on  of  the  Bri.sh  Pharmaceu.cal  Industry  has  also  come  out   with  specific  guidelines  for  managing  adverse  events  on  pharma  owned  or   sponsored  Web  sites.  Interes.ngly,  the  guidelines  ignore  the  “iden.fiable   reporter”  condi.on  required  by  the  FDA  for  an  AE  to  be  “reportable.”   The  Brits  have  also  issued  some  guidance  for  using  TwiAer  to  communicate   with  physicians,  making  correc.ons  to  Wikipedia  –  an  issue  discussed  in  a   previous  slide  –  and  appropriate  use  of  metadata.     You  can  find  details  by  following  the  links  given.  
  • 20. Despite  the  lack  of  FDA  guidance,  pharmaceu.cal  marketers  have  come  a   long  way  in  integra.ng  social  media  into  their  overall  marke.ng  strategy.   These  are  data  from  the  Social  Media  Readiness  survey  tool  I  have  been   running  since  December,  2007.  Over  300  marketers  working  for  drug  or   device  companies  have  taken  the  survey.  The  survey  asks  ques.ons  to   evaluate  readiness  in  three  categories:  regulatory  (e.g.,  aversion  of  risk),   culture  (e.g.,  sensi.vity  to  cri.cism),  and  personal  experience.  Scores  are   calculated.  This  compares  scores  prior  to  July,  2009,  with  scores  aDerward.   Not  every  pharma  company,  however,  is  at  the  same  point  in  the  adop.on   curve.  Some  are  more  willing  to  take  "risks,"  some  are  more  savvy  about   applicable  FDA  regula.ons,  and  some  are  more  knowledgeable  about   social  media  in  general.     Let’s  see  how  Roche  did.   20
  • 21. These  results,  of  course,  are  based  on  a  very  small  number  of  responses.   It  seems,  however,  that  Roche  employees  feel  that  the  company  is  savvy   regarding  the  regulatory  issues  rela.ng  to  social  media  but  lacks  the  type   of  culture  required  to  be  comfortable  with  making  social  media  mistakes.   If  you  have  not  taken  the  survey,  please  do.  I  can  report  back  updated   results  aDerward.     21
  • 22. Let’s  look  at  more  detail  regarding  how  pharma  employees  rate  their   companies’  readiness  to  deal  with  social  media  readiness  issues.   You  can  see  that  in  the  early  period  prior  to  July  2009,  the  majority  of   respondents  thought  their  companies  had  a  “very  cau.ous”  regulatory   climate  with  only  24%  saying  the  climate  was  “very  aggressive.”  Theses   days,  it  seems  from  these  results,  pharma  companies  are  seen  as  much   less  cau.ous  and  more  aggressive.   I  guess  that  is  due  to  the  lack  of  significant  FDA  “warning”  leAers  being   sent  that  involve  social  media.  In  other  words,  the  “received  wisdom”  is   that  pharma  companies  are  nego.a.ng  the  social  media  regulatory   challenges  without  specific  guidance  from  the  FDA.   Be  careful  though!  The  FDA  hammer  may  fall  again  just  as  it  did  the  day   aDer  April  Fools’  Day  in  2009.   22
  • 23. While  pharma  may  be  gexng  more  comfortable  engaging  in  social  media   without  FDA  guidance,  there  has  been  some  retrenchment  in  adop.ng   social  media  for  marke.ng.   For  example,  there  are  fewer  pharma  Facebook  pages  today  than  there   were  prior  to  August  15,  2011,  when  Facebook  changed  its  policy  on   comments.  ADer  the  change,  which  did  not  allow  pharma  companies  to   turn  off  comments  to  their  Facebook  pages,  many  companies  just  shut   down  their  pages.   "This  new  policy  will  alter  our  ability  to  consider  the  appropriateness  of   comments  before  they  are  posted  which  is  important  to  us  as  a  company   in  a  highly  regulated  industry,”  said  McNeil  Pediatrics  when  it  shut  down   its  ADHD  Moms  page.    
  • 24. An  example  of  this  was  the  shutdown  of  the  Psoriasis  Facebook  page  by   Janssen  Pharmaceu.cals.  This  page  –  launched  in  October,  2010  –  was  the   first  pharma  Facebook  page  that  published  comments  BEFORE  reviewing   but  reserved  the  right  to  delete  them  aDerward.   Janssen  cited  its  inability  to  moderate  posts  made  to  the  Psoriasis  360     wall,  one-­‐third  of  which  "men.on[ed]  a  specific  drug  by  name,  or  talk[ed]   about  the  efficacy  of  a  par.cular  treatment  is  (or  its  side  effects)."  In  such   cases,  Janssen  had  to  ask  for  the  post  to  be  removed  or  to  "pull"  it.     Perhaps  this  decision  represents  a  lack  of  commitment  aDer  Alex  Butler,   former  Janssen  Digital  Strategy  and  Social  Media  Manager,  leD  the   company.  Alex  was  the  person  responsible  for  Psoriasis  360.  For  his   efforts,  I  awarded  him  the  first  ever  Pharmaguy  Social  Media  Pioneer   award.   Another  example  was  the  shutdown  of  the  ADHD  Moms  Facebook  page   by  McNeil  Pediatrics.  This  was  the  first  pharma  Facebook  page  –  launched   in  June,  2008.   "This  new  policy  will  alter  our  ability  to  consider  the  appropriateness  of   comments  before  they  are  posted  which  is  important  to  us  as  a  company   in  a  highly  regulated  industry,”  said  McNeil.    
  • 25. There  were  examples  of  pharma-­‐owned  or  sponsored  open  discussion   boards  even  before  Facebook  became  popular.  GSK’s  Ques.onEverything,   which  was  launched  in  April,  2006,  is  an  example.  It  allowed  comments   from  consumers  and  posted  them  aDer  review  (“pre-­‐modera.on”).   This  site  is  no  longer  available.   Pre-­‐modera.on  –  where  possible  –  may  be  the  best  prac.ce  for  pharma   social  media  sites,  including  YouTube.   However,  these  days,  very  few  pharma  companies  allow  any  comments  at   all,  which  is  a  shame  because    that  is  the  best  way  to  build  community  and   aAract  more  viewers  
  • 26. Of  course,  there  is  good  reason  why  pharma  companies  fear  comments  on   Facebook  as  this  case  demonstrates.   However,  this  could  have  been  prevented:   •  Problem  #1:  No  one  at  S-­‐A  was  monitoring  this  site  or  seemed  to  be   responsible  for  it.   •  Problem  #2:  There  was  no  policy  in  place  for  what  cons.tutes   acceptable  comments  and  how  comments  would  be  moderated  or   deleted.   •  Problem  #3:  There  was  no  social  media  “crisis  management  plan”  other   than  “remove  all  comments!”    
  • 27. Sanofi  learned  from  its  mistakes  and  even  spoke  about  them  in  a  public   forum;  i.e.,  my  Pharma  Marke.ng  Talk  show  .tled:  “What  Sanofi-­‐Aven.s   Learned  from  Its  FaceBook  Experience  &  What  the  Experts  Recommend  It   Do  Now.”  In  that  show  I  interviewed    Dennis  Urbaniak,  VP  U.S.  Diabetes.     Listen  to  the  podcast:  hAp://bit.ly/PMT098     The  Sanofi  US  Diabetes  team  won  the  third  (2012)  Pharmagy  Social  Media   Pioneer  Award.    
  • 28. Even  the  biggest  pharma  company  in  the  world  can  be  humbled  by   Facebook  backlash.  In  this  case,  it  was  Pfizer  and  the  product  is  not   regulated  by  the  FDA.  Nevertheless,  it  illustrates  how  important  it  is  to   pay  aAen.on  to  what’s  going  on  in  the  social  media  spaces  that  you  own   and  to  have  a  “crisis  plan”  in  place.   The  issue  was  this:  Pfizer  selec.vely  deleted  “nega.ve”  comments  in  an   aAempt  to  control  the  discussion.   What’s  the  lesson?   You  are  NOT  in  control  of  the  discussion  on  social  media.   This  is  pharma’s  major  social  media  conundrum:     (1)  pharma  marketers  are  used  to  controlling  the  discussion  (or  not  having   a  discussion  at  all),  and     (2)  pharma  marketers  are  legally  responsible  for  the  content  of  the   discussions  on  sites  they  own.  
  • 29. Although  Pfizer  got  into  trouble  with  comments  on  Facebook,  it  did  not   shrink  from  allowing  comments  on  other  social  media  sites  like  its  “Get   Old”  community.   On  June  18,  2012,  Pfizer  launched  "Get  Old,"  a  mul.-­‐year  ini.a.ve   supported  by  nearly  a  dozen  advocacy  organiza.ons.     Registered  users  can  post  links,  videos,  photos,  or  stories  (including   comments  up  to  1000  characters)  to  the  site.  You  can  even  submit   comments  to  other  posts  and  "Like,"  tweet,  or  email  comments.  Every   comment  submiAed  is  reviewed  before  being  uploaded  -­‐  a  process  that  is   completed  within  48  hours.   Pfizer  says  it  has  a  social  media  “Playbook,”  according  to  Ray  Kerins,   Pfizer’s  former  Vice  President  of  Worldwide  Communica.ons.  “While  I   don't  want  to  say  it's  proprietary,”  said  Kerins,  “I  also  don't  want  to  make   too  big  of  a  deal  about  it  because  we  call  it  common  sense.”  
  • 30. In  the  U.S.,  of  course,  direct-­‐to-­‐consumer  branded  drug  adver.sing  is   permissible,  but  is  it  always  necessary?   I  cri.cized  this  tweet  as  “sleazy  twiAer  spam”  because  I  did  not  follow   this  account  to  receive  branded  messages  but  to  learn  more  about   how  the  celebrity  racecar  driver  Charlie  Kimball  coped  with  managing   his  diabetes  while  racing.     Although  the  adver.sed  product  is  part  of  the  story,  this  tweet  had  no   educa.onal  value  and  was  merely  a  “product  placement”  or   “reminder”  type  of  ad  that  PhRMA  says  should  not  be  used  –  at  least   on  TV.  But  if  it’s  not  OK  for  TV,  it  should  also  not  be  OK  for  social   media.   Anyway,  Novo  Nordisk  par.cipated  in  open  discussion  about  this  and   learned  –  I  haven’t  seen  any  other  tweets  like  this  since.   Listen  to  this  Pharma  Marke.ng  Talk    podcast:  “Novo  Nordisk's  Race   With  Insulin  Campaign:  It's  Not  Just  About  TwiAer”     hAp://bit.ly/PMTalk087    
  • 31. Back  in  November,  2011,  I  asked  “Will  a  Pharma  Company  Ever  Host  a   Chat  on  TwiAer?”  (hAp://bit.ly/Twchat).  I  answered  my  own  ques.on   with:  “most  pharma  companies  may  never  directly  host  or  moderate   TwiAer  chats  because  they  can  control  neither  the  audience  nor  the   message.”   So,  I  was  surprised  when  Astrazeneca  hosted  the  first  live  TwiAer  chat   session  on  February  16,  2011.     Despite  dire  predic.ons  of  "PR  failure,"  the  chat  was  a  great  success  and   proof  that  a  pharmaceu.cal  company  can  indeed  host  meaningful  TwiAer   chats.   There  were  a  few  aAempts  by  two  or  three  "malcontents"  to  "hijack"  the   conversa.on.  These  people  made  the  most  tweets  that  included  the   #rxsave  hash  tag,  but  despite  their  aAempts  to  ask  "the  tough  ques.ons"   about  off-­‐label  promo.on  of  drugs  and  Seroquel  side  effects,  everyone   completely  ignored  the  hijackers  and  the  conversa.on  con.nued  as  if   these  people  were  not  even  there.   Tony  Jewell  (@tonyjewell),  Senior  Director  of  External  Communica.ons  at   AstraZeneca  US,  received  the  2nd  Pharmaguy  Social  Media  Pioneer  award   for  his  pioneering  use  of  TwiAer.  
  • 32. It  is  one  thing  to  host  a  TwiAer  chat  where  you  can  control  what  is   being  posted  by  your  representa.ve(s)  as  part  of  that  chat.  But  it  is   quite  another  problem  controlling  unauthorized  tweets  made  by   employees  without  the  knowledge  of  your  MLR  people  as  this  case   illustrates.   A  “Global  Social  Media  Policy”  doesn’t  mean  much  unless   •  It  is  publicly  available  so  the  company  can  be  held  accountable  in  a   transparent  fashion,  and   •  Employees  are  trained  in  the  policy,  which  should  include  sanc.ons   such  as  dismissal  for  viola.on  of  the  policy.  
  • 33. Having  social  media  principles  that  guide  how  your  employees  use   social  media  and  interact  with  the  public  online  is  a  good  first  step.  But   if  they  are  to  have  any  effect,  employees  must  be  TRAINED  to   understand  how  to  apply  the  principles  in  the  real  world.  And,  as  with   privacy  policies,  the  fact  that  employees  receive  this  training  should  be   stated  in  the  outward-­‐facing  social  media  policy  that  the  company   publishes.   These  are  just  a  few  of  my  “half-­‐baked”  ideas  pertaining  to  a  public   social  media  policy  for  pharmaceu.cal  companies  to  adopt.  
  • 34. Roche  is  the  only  pharmaceu.cal  company  that  has  publicly  disclosed   its  social  media  principles.  Bravo!    
  • 35. In  closing,  I  would  like  to  emphasize  that  to  implement  a  strategy  for   using  social  media  as  part  of  your  marke.ng  campaigns,  it  is  important   to  have  a  plan.  But  what  are  the  ac.on  items  for  implemen.ng  your   plan?     This  survey  asked  respondents  to  indicate  how  important  the  following   ac.on  items  are  in  implemen.ng  a  social  media  plan:   •  #1:  Get  everyone  -­‐  including  marke.ng,  regulatory  people,  corporate   communica.ons,  C-­‐level  execs  -­‐  on  board   •  #2:  Become  a  dialogue  company  -­‐  learn  how  to  listen  and  respond,  not  just   push  messages  out   •  #3:  Have  a  sustained  vision/goal   •  #4:  Train  people  who  will  be  interac.ng  directly  with  consumers   •  Create  a  social  media  Tsar  posi.on  to  oversee  all  the  company's  SM  projects   to  assure  compliance  with  guidelines   •  Develop  a  modera.on  strategy   •  Develop  guideposts,  internal  and  external  standard  opera.ng  procedures   •  Marshall  necessary  resources  -­‐  use  the  best  tools  available   •  Unblock  corporate  access  to  social  media  so  employees  can  monitor  and   use  applica.ons  such  as  Facebook  while  at  work   35