FALL 2010

PETER J. PITTS
Senior Partner and Director of
Global Regulatory and Health Policy
 PETER J. PITTS
Senior Partner and Director of Global Regulatory and Health Policy
Porter Novelli New York
Peter.Pitts@portenovelli.com | 212.601.8208

WHAT DOES
PHARMA
Want?
During a past episode of Mad Men, the creative team at Sterling/Cooper was hard at work
brainstorming on a “women’s product” campaign when someone asked, “What do women want?”

Strolling by, Roger Sterling quipped, “Who cares?!”

Well, when it comes to social media, what does pharma want – and who cares?

Many will say “regulation from the FDA” – in fact, a great many. But is that really what pharma
wants?

Yesterday I participated in a small roundtable (sponsored by AstraZeneca) on “Examining the

Roles of the FDA and the Pharmaceutical Industry in Social Media.”

(Full disclosure: AZ is a client of Porter Novelli’s in Europe, and I ate two small eggplant and
tomato tea sandwiches and drank 2.5 cups of organic coffee. I did not offer to reimburse AZ
for the “gift.”)

What does pharma want? One of the opening comments was that pharma wants the “ability
to engage” in social media. My response to that was to ask whether pharma has the “will” to
engage – because they certainly have the ability if they choose to use it. And where there’s a
will, there’s a way.

Another issue that came up early – and that generated a lot of conversation – was the need to
bifurcate the discussion of digital advertising from that of social media. There are rules for
digital advertising, paid digital advertising. Social media, on the other hand, is where the action
is and the opportunities reside. It’s the crucial gray zone that exists between regulated speech

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 “PHARMA SHOULD EXPLAIN TO
PEOPLE WHY THEY’RE NOT THERE.”
and user-generated content. It’s where the
rubber meets the road.
What pharma wants (or should want) is
specific areas of clarification from the FDA
on this new and exciting zone of opportunity.
What of the empowered digital health care
consumer we hear so much about? Well –
there were a few of them in attendance at
the AZ confab and they had some interesting
things to say.
What struck a chord for me was when one of
the civilians in the room (by which I mean a
patient) said that she really had no idea why
pharmaceutical companies chose to absent
themselves from disease-related social
media conversations. She assumed it was
because Big Pharma is afraid of mixing it up
with real people in real time dialogue.
And she’s right, of course – but for reasons
she didn’t suspect. The ensuing explanations
of adverse event reporting and other
compliance-related issues didn’t cause her
to nod her head, but rather to say (indeed,
almost insist) that “pharma should explain to
people why they’re not there.”
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Blame the FDA! was the knee-jerk reaction.
But that’s not fair and it’s not true. How
can the agency be blamed for industry’s
reluctance to push the boundaries – even
a little? Fear of warning letters? Fear of
unearthing adverse events? I say, where
there’s a will, there’s a way. If you won’t
blaze the path – even a little – then don’t
expect anyone to know where you want to go.
Unfortunately, blazing new territory through
real-time learning is not, shall we say,
historically a tradition of the pharmaceutical
industry. Everyone wants to do new and
exciting things – second.
Here’s an even more basic question – what’s
the right thing to do? I submit that it’s
irresponsible to actively avoid participating
in the social media health care conversation.
It is, to directly quote Center for Drug
Evaluation and Research Director Dr. Janet
Woodcock, “where the people are.” Health
care begins at search.
But, someone pushed back, that’s why we
need more directive regulation from the
FDA. I fundamentally disagree that (1), that’s
what’s needed and (2), that’s what’s coming.
Let me explain.
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(1) In my humble opinion, “We need more
regulation” just doesn’t cut it. Since there is no
direct “request” from industry, it’s impossible
to expect the FDA to offer direct guidance.
It’s not like requesting guidance for direct-
to-consumer advertisements. That was a
precise request for a tangible deliverable
that resulted in direct and specific rules and
regulation. More regulation? Be careful, that
may be precisely what you get. Also, “more”
guidance means nothing without a more
precise reference. “More” relative to what
aspects of social media? These details were
lacking at last November’s Part 15 hearing
and (alas) equally so in the lengthier (but
equally non-specific) docket submissions.
(2) What are the odds, lacking direction,
expertise and experience, that FDA’s
Division of Drug Marketing, Advertising and
Communications (DDMAC) will deliver some
kind of deus ex machina solution? Expecting
the Holy Grail will only lead to disappointment
and frustration. And blaming the FDA when
that happens won’t make anything better or
move the social media agenda any further
ahead. If industry is expecting to climb the
steps of FDA headquarters at White Oak on
its knees, kiss an FDA relic and miraculously
throw away the crutches hobbling its ability
to participate in social media, well, there had
better be a Plan B.
Where there’s a will, there’s a way.
Then there’s the question of language and
syntax. For example, what does “sponsored”
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mean? Let’s do a brief thought experiment.
Consider a televised PGA tour event. When
a product logo for an erectile dysfunction
medicine appears on the screen and the
announcer intones, “This portion of the
Masters is sponsored by DRUG NAME
HERE,” nobody out there in the viewing
audience takes that to mean the “sponsor”
has chosen the speed of the greens, the
height of the rough or the pairing of golfers
in the tournament. But say “sponsored” on
a social media site and watch the sparks fly
at internal regulatory review. Fore! This also
leads to the still vague regulatory distinction
between property owner and property user
– an issue in dire need of FDA clarification.
Discussion of this important social media
issue in FDA docket submissions? Try and
find it.
Of course, there’s the subtle but crucial
differentiation between “permissible” and
“appropriate.” And this returns us to where
we started. What does pharma want? Do
they want social media, primarily, as a
new channel for marketing or do they see
it as a new and exciting and robust and
dynamic mechanism for advancing the
public health through real-time interactive
communications?
Indeed – why not both? Where there’s a will,
there’s a way.
And AZ – thanks for the sandwiches and
kudos for a job well done.
What Does Pharma Want? | 4
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