Medical & Health initiatives led the way in 2013 at SXSW. But what were missing were Big Pharma and the FDA.The FDA 3 years ago promised guidance on Pharma social practices and 2 years ago promised guidance on Pharma mobile health apps and medical devices. They released preliminary guidance, had a public forum, but never made good on their promise. In the mean time Pharma companies have been trying to couple their drugs with actionable care solutions. The gray area is around patient tracker apps. The original guidance said “anything that helps the doctor make a treatment decision is a medical device”, but the community said, “hold it, how is that different from a paper and pen journal?” The FDA responded at an open forum, yet they never released guidance. So,many pharma companies are afraid of getting a letter. Our discussion will focus on what we can do to improve the submission and approval process of medical apps and devices through the FDA.

1. Naviga&ng
the
Uncertain
Waters
of
the
FDA
Big
Pharma
&
Mobile
Tech

2. Meet
the
Presenters:
2013
©
MRM
All
Rights
Reserved
Timothy
Makoid
User
Experience
InnovaFon
Lead
Benjamin
Weisman
SVP
Director
of
CreaFve
InnovaFons

3. 1. Why
should
we
trust
big
Pharma?
2. What’s
holding
up
innovaFon?
3. What’s
the
deal
with
the
FDA?
4. What
can
we
do
about
it?
Our
Presenta&on
Will
Cover:

4. 2013
©
MRM
All
Rights
Reserved
Why
should
we
trust
Big
Pharma?
• Pharma
owes
you
one…
and
they’ve
got
the
money
• They’ve
got
great
talent
• They’re
one
of
the
most
knowledgeable
resources
in
the
world
on
diseases
and
treatments
and
they
have
their
finger
on
the
pulse
of
the
medical
and
HCP
communi&es
• They
have
endless
amounts
of
pa&ent
and
HCP
data
and
they
know
their
customer
well

5. 2013
©
MRM
All
Rights
Reserved
What’s
Holding
Up
InnovaFon?
Actually
it’s
happening
all
the
&me
behind
the
scenes
but
a
large
por&on
of
well
designed
mobile
health
technology
never
sees
the
light
of
day
because
of
MLR
and
the
FDA.

6. 2013
©
MRM
All
Rights
Reserved
What’s
MLR:
Medical/Legal/
Regulatory
Every
pharma
company
has
a
team
of
lawyers
that
review
anything
released
by
the
company
to
insure
that
they
don’t
release
anything
that
will
get
them
in
trouble
with
the
FDA.

7. 2013
©
MRM
All
Rights
Reserved
So
what’s
the
deal
with
the
FDA?
ANer
3
years
of
promising
guidance
on
Pharma
social
and
mobile
prac&ces,
we’re
s&ll
leN
wondering
what
we
are
and
aren’t
allowed
to
do.
Because
of
this
a
lot
of
MLR
reviewers
are
afraid
to
proceed
without
clear
guidance.
This
accounts
for
millions
of
dollars
of
lost
ini&a&ves
that
could
be
going
towards
helping
pa&ents
deal
with
their
condi&on
and
treatment
and
helping
HCPs
educate
and
socially
communicate
with
each
other
and
their
pa&ents.

8. 2013
©
MRM
All
Rights
Reserved
So
what
can
we
do
about
any
of
this?
• We
need
to
keep
this
conversaFon
going.
RegulaFon
is
important,
and
that’s
why
we
need
the
FDA
to
provide
us
with
some.
We’re
not
asking
for
free
reign,
just
guidelines
so
we
can
start
innovaFng.
• Speaking
of
innovaFng,
keep
doing
it.
The
more
health
tech
that
hits
the
market,
the
less
likely
Pharma
can
deny
itself
an
opportunity
to
join
the
movement.
And
the
more
money
spent
on
health
tech,
the
beXer.
• Communicate
with
the
FDA.
Let
them
know
that
we
want
guidance
now
and
that
they’re
holding
up
innovaFon
in
America.

9. So
if
you’d
like
us
to
talk
about
any
of
these
issues
please
vote
for
us
for
SXSW
InteracFve
2014.
Thanks!
2013
©
MRM
All
Rights
Reserved

10. Who
is
MRM?
2013
©
MRM
All
Rights
Reserved
CommunicaFons
eCommerce
PharmaceuFcals
Technology
AutomoFve
Online
Trading

11. 2,300+
Cra]speople
500+
Technologists
150+
Social
Architects
300+
Data
&
AnalyFcs
We
Are:
2013
©
MRM
All
Rights
Reserved