fda social media

PHARMA, THE FDA & SOCIAL MEDIA:Uncertainty Can Be A Guiding Light

“Uncertainty Can Be A Guiding Light”-U2, Zooropa 1993

White Blood Cell Count: 50,000

What I Will Address

• What the FDA has said, will likely say, and is not going to say.

• The business case for embracing uncertainty

• 6 Misconceptions for social media

• What this means for Canadian Pharma and Pharma overall

• Q&A

First, 3 Facts:

Fact #1:The World is Getting Older, Faster

10k x 365 x 19 years

Fact #2:Traditional DTC Marketing Models are losing effectiveness

Fact #3:The FDA has yet to issue anything since Part 15 hearings.

FDA: what they have said, are going to say, and are not going to say

FDA: What They Have Already

Said.

“Follow the regulations”

Advise given by Tom Abrams, the head of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), regarding Pharma & Social Media Feb 2011

What They FDA Has Said

1. Adverse Event information must be included in all DTC advertising materials.

2. Reports of Adverse Events must be reported if they meet 4 basic criteria.

3. Companies are required to ensure that adverse information is listed and is accurate on any site that is sponsored by the product manfactuer.

What the FDA Has Said:

52 Warning Letters in

2010.

SOURCE: Eye on FDA: http://www.eyeonfda.com/eye_on_fda/2011/01/ddmac-warning-and-nov-letters-lookback-for-2010.html

SOURCE: Eye on FDA: http://www.eyeonfda.com/eye_on_fda/2011/01/ddmac-warning-and-nov-letters-lookback-for-2010.html

Only Social Media Violation in 2010: Established Rule

FDA: What They Are (Most

Likely) Going to Say.

•What Constitutes a “Sponsored” site?

•Safe Harbor for correct information (i.e. Wikipedia)

• Safe Harbor for Adverse Events (does not have to monitor every single site)

• Possible clarity on “One Click” Rule

Low Hanging Fruit

FDA: What They Are Not Going

to Say

Do Not Expect 100% Clarity

The FDA will not "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter …”

Tom Abrams, the Head of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) , Feb 2011

Do Not Expect 100% Clarity

“…DDMAC is unlikely to create a major new standard for social media…”

John KampDirector,Coalition for Healthcare Communication

Do Not Expect 100% Clarity

“…It’s impossible to expect the FDA to offer direct guidance [on Pharma & Social Media]”

Peter PittsDirector of Global Regulatory, Porter NovelliFormer Deputy Commission, FDA

impossible?

Do Not Expect 100% Clarity“The real question is whether Pharma has the will to engage, because they certainty have the ability if they choose to use it.”

Peter PittsDirector of Global Regulatory, Porter NovelliFormer Deputy Commission, FDA

The Pharma Business Case for Embracing Uncertainty

“In the age of Facebook and Google, it seems there should be a better, more systematic way of harnessing this communal wisdom and cultivating this sort of medical discovery. Enter open innovation.”

Past: Closed Innovation Future: Open Innovation

Chess:•Clear, specific, unchanging rules•Finite set of pieces•Finite Set of moves•Clear how investment can lead to victory•Largest dynamic is intellectual•No ambiguity

Poker:•Few basic rules, but they can be modified•Finite set of pieces, infinite set of moves•Unclear how investment will lead to victory•Largest dynamic is social, emotional•Lots of Ambiguity. Lots of Risk.

Past: Closed Innovation Future: Open Innovation

Misconceptions about theFDA & Social Media

Misconception #1

Social Media = Digital Advertising

/

Misconception #2

Social Media Content = Social Media Platform

/

X X

X X

Misconception #3

Having a Presence in Social Media = Being Social

/

Dialogue is at the heart of social media

Misconception #4

All Adverse Events Must Be Reported

FDA Criteria for AE Reporting

1.An identifiable patient.2.An identifiable person reporting the

event.3.A suspect drug or biological

product.4.An adverse experience or fatal

outcome suspected to be due to the suspect drug or biologic.

5

500: 1Among 500 messages

analyzed, one message incorporated all four AE

reporting criteria

2008 Study:Listening to Consumer in a highly regulated environment

# reported = 0

Misconception #6

The FDA is going to provide clear guidelines for every possible

aspect of social media.

3 Future Trends and What This means for Canada Pharma

Trend #1:Non-branded Corporate Communications will become the most dominant form of Pharma Social Media

Trend #2: Brand as publisher. Beyond CSR content shift toward non –branded education content

Trend #3: The New DTC = Direct to Customer

DTC: Direct to Customer

•Cost of patient non-compliance = $30 Billion•Companies will focus on adherence as much as acquisition• High produced educational videos vs. hard to read drug information text• Both public facing videos (disease content) and password protected (product direct content) video. May not be consider DTC.• Same energy and production values in pre-purchase should be applied to post purchase

• Focus on Global Corporation Communications• Brand as publisher: Educational non-branded content• The New DTC = Direct to Customer

Thank You

Brad B McCormick

Global Digital Director

Porter Novelli

Brad.mccormick@porternovelli.com

646 662 6297

@darbtx