what does pharma want

8/8/2019 What Does Pharma Want

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FALL 2010

PETER J. PITTS

Senior Partner and Director ofGlobal Regulatory and Health Policy



2What Does Pharma Want? |PORTER NOVELLI | AMPLIFY

WHAT DOES

PHARMAWant?

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 awill, 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

PETER J. PITTSSenior Partner and Director of Global Regulatory and Health Policy

Porter Novelli New York

[email protected] | 212.601.8208



4What Does Pharma Want? |PORTER NOVELLI | AMPLIFY

(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 (butequally 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 ormove 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”

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 theMasters 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 anew 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.



Porter Novelli Global Headquarters75 Varick Street, 6th FloorNew York, NY 10013Direct 212.601.8000Fax 212.601.8101

www.porternovelli.com

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