© 2013 Pharmaguy

Overcoming Pharma’s Social Media & Mobile Challenges

Presented 11 June 2013 at:

Bayer PharmaBerlin, Germany

© 2013 Pharmaguy

Learn from Milestones & Mistakes

Milestones – Important “firsts” have

paved the way for cautious followers.

Mistakes – Best way to learn & benefit

from your competition’s errors.

“Constant Effort and Frequent Mistakes are the Stepping Stones to Genius”

Elbert Hubbard, American writer

2

© 2013 Pharmaguy3

Pharmaguy Has Been There (at FDA), Done This

Testified as Panel Member at 1996 FDA Hearing on Internet

Co-Founded Internet Healthcare Coalition (1997)

Co-Authored the eHealth Code of Ethics (2000)

Blogged About Pharmaceutical Digital Marketing Practices Since 2005

Presented Survey Results at the 2009 FDA Hearing on Social Media

© 2013 Pharmaguy

FDA Sends 14 Warning Letters

FDA sends 14 letters on a single day to major pharmaceutical companies concerning their Google and Yahoo Rx paid search ads. Letters were dated 29 March 2009, but made public on 2 April 2009.

April 2, 2009

4

1 April 2009: Pharmaguy posted fake “April Fools” press release announcing publication of FDA guidance on pharma’s use of social media.

© 2013 Pharmaguy5

FDA Hosts Public Hearing

November 12-13, 2009

“This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.”

April 2, 2009: Pharmaguy issued first public call for FDA public hearing on social media. “We should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.”

© 2013 Pharmaguy6

Survey Results Submitted to FDA

Accountability, Disclosure, Corrections

Fulfilling Regulatory Requirements with Regard to Fair Balance and Submission for Review

Posting Corrective Information

Adverse Event Reporting

354 Responses575 Comments

http://bit.ly/fdasmSurvey

© 2013 Pharmaguy

Accountability

For what online communications are manufacturers, packers, or distributors accountable? In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?

When marketer or agent sponsors the discussion (e.g., provides a specific grant to independent 3rd-party host such as a patient advocacy group to sponsor the discussion)

When marketer or agent paid for the content (e.g., paid patients for testimonials or otherwise provided compensation)

When marketer or agent paid for display ads to be run on specific discussion pages (e.g., only discussions related to the product advertised)

3rd-Party Independence

7

© 2013 Pharmaguy

Accountability: Best Practices

DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible. Half of survey respondents agree

Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.]About two-thirds of survey respondents agree

Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should only be REQUIRED to do so only for sites owned or directly sponsored by them.

8

© 2013 Pharmaguy

Parameters for Correcting Misinformation

Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?

ONLY misinformation of real and imminent danger to the public health (to be determined by company) should be corrected

ALL off-label claims—even if supported by peer-reviewed medical literature—should be corrected)

Only off-label claims NOT substantiated by peer-reviewed medical literature should be corrected

Companies should not be burdened by FDA regulations requiring them to make corrections about ANY product misinformation published on 3rd-party sites

Posting Corrective Information

9

© 2013 Pharmaguy

Should Pharma Edit Drug Articles on Wikipedia?

10

© 2013 Pharmaguy11

What challenges are presented in handling adverse event information from these sources?

The amount of information from these sources is potentially too vast to be processed economically (lack of resources)

Finding adverse event information from these sources is like finding a needle in a haystack (too daunting)

The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable)

There are many potential issues that won't fully be known until the practice of monitoring social media for AEs is more prevalent (unknown issues)

Adverse Event Reporting

Social Media Adverse Event Challenges

© 2013 Pharmaguy

“UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” -- Peter Verdru, MD, UCB’s Vice President of Clinical Research

Goal: Generate patient-reported outcomes that may help

UCB better understand how patients live with epilepsy

and help advance epilepsy care.

Provides disease tracking tools

Deployed a system for reporting adverse events to FDA

12

UCB Embraces Adverse Events on Sponsored PatientsLikeMe Epilepsy Discussion BoardJune 16, 2009

© 2013 Pharmaguy13

13 June 2011: ABPI Pharmacovigilance Expert Network (PEN)

published “Guidance Notes” on management of AEs on pharma

owned/sponsored Websites; AEs should be collected and

documented, regardless of seriousness of event and whether or not

there is an identifiable reporter (http://bit.ly/BritAEguide)

1 April 2011: PMCPA issued “informal guidance” for applying its

Code to social media; e.g., communication with physicians via

Twitter, corrections to Wikipedia, appropriate use of metadata (

http://bit.ly/PMBBritsvFDA)

EU Online AE Reporting & Twitter Guidance

© 2013 Pharmaguy14

"Miscellaneous Provision" of the "Food and

Drug Administration Safety and Innovation Act"

(aka PDUFA)

“Not later than 2 years after the date of

enactment of this Act, the Secretary of Health

and Human Services shall issue guidance that

describes Food and Drug Administration policy

regarding the promotion, using the Internet

(including social media), of medical products

that are regulated by such Administration.”

FDA's "Social Media Guidance Cliff"

New Deadline is July 2014

As of 30 May 2013, no “actions completed” reported in FDASIA-TRACK

© 2013 Pharmaguy15

December 27, 2011

Section VI addresses responding to unsolicited

requests on public forums such as the Internet

and "emerging electronic media”

Cites cases on YouTube, blogs, and Twitter:

Pharma should respond to unsolicited requests

via private channels

“FDA recommends that sales and marketing

personnel have no input on the content of

responses to unsolicited questions or

requests for off-label information”

FDA Off-Label Guidance & Social Media

© 2013 Pharmaguy

Pharma is Overcoming Social Media Hurdles

16

© 2013 Pharmaguy

Pharma is Overcoming Social Media Hurdles

17

Period I: 54%Period II: 30%

Period I: 24%Period II: 42%

© 2013 Pharmaguy

Published all comments before reviewing, but reserved right to delete comments if offensive or mention ANY product.

18

October 7, 2010

Evolution of Pharma’s Facebook Comment Policy

Alex Butler, Janssen Won the 2010 Pharmaguy Social Media Pioneer Award

© 2013 Pharmaguy

Sanofi-Aventis Vs. Patient on Facebook

19

March 15, 2010

The pharmaceutical industry’s worst fear was realized when a “disgruntled patient” posted multiple adverse event messages and photos on the wall of a Sanofi-Aventis Facebook page (VOICES). The page did not have comments turned off and did not include any terms of use.

© 2013 Pharmaguy

Sanofi Didn’t Give Up on Facebook

20

August 11, 2011

“Likes” have grown from 522 in January 2011 to over 6,700 in June 2013.

“Since we operate in a heavily regulated industry, we… must preview all messages.”

“While some messages may not be posted, we are listening and encourage you to continue sharing.”

Sanofi US Diabetes Won the 2012 Pharmaguy Social Media Pioneer Award

© 2013 Pharmaguy

I called this tweet “Sleazy Twitter Spam”

Challenge (US): How to fit benefits and fair balance in 140

characters or less?

Challenge (Globally): How to make it meaningful for patients

We’re Still Friends!

21

First (& Only?) Pharma Rx Branded Tweet!June 18, 2009

© 2013 Pharmaguy

First (& Last?) Live Pharma Twitter Chat

22

February 16, 2011

AstraZeneca hosted a one-hour chat on Twitter to raise awareness about helping patients save money through prescription savings programs.

Tony Jewell, AZ, won the 2011 Pharmaguy Social Media Pioneer Award

© 2013 Pharmaguy23

December 13, 2011

The Prescription Medicines Code of Practice Authority

(PMCPA) ruled Allergan breached the Code on several counts

after an employee accidentally tweeted publicly about Botox

Employee violated Allergan’s "Global Social Media Policy”

that clearly stated "no Allergan employee might comment in a

social media forum about Allergan products or business

activity."

Should pharmacos make their SM policies public to be more

transparent & accountable?

Pharma Employee Tweet Problem

© 2013 Pharmaguy24

A promise to visitors of SM sites you own or sponsor about how YOU will behave, not how you expect THEM to behave

Think of it as serving a similar purpose as your privacy policy Includes:

Your comment moderation policy; this requires more details than what has been seen to date

Rules for participation by your employees (reflects the internal policy that your employees are trained on)

Rules for participation by agents of your company (should be same as apply to your employees; trained on also)

Other “rules of engagement”; e.g., correction of misinformation

Thoughts on an Outward-Facing SM Policy

© 2013 Pharmaguy

What's Your Social Media Implementation Plan?

25

© 2013 Pharmaguy

Is This the Typical Mobile Health App Developer Hired by Pharma?

Easy entry into mHealth offers incredible opportunity for innovation in healthcare; however, the open market comes with certain concerns, namely, “how credible are the apps I am (or my patients are) using?”

26

Are developers knowledgeable about applicable regulations, laws, and pharma sensibilities?

© 2013 Pharmaguy

Undocumented & Untested(?) Medical Apps

27

Psoriasis app by Janssen includes a “PASI” (Psoriasis Area and Severity Index) calculator

No citation of source used to perform calculation – was it the equation above?

No disclaimer such as "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein.”

Was the app tested and certified by a third-party?

Is it an “MMA” subject to FDA regulation?

© 2013 Pharmaguy

The First Ever “Dear Doctor” Letter Regarding a Mobile Medical App Recall

28

Pfizer Rheumatology Calculator Most downloaded app tracked

by POCKET.MD (5-Star user rating)

Recalled via a “Dear Doctor” Letter in October 2011 because of "a bug in the app ... gives wrong results.”

© 2013 Pharmaguy

Reigning in the “Wild West” of Mobile Health Apps

29

Inaccurate Health Apps Overzealous FDA Regulation? Good App Privacy Practices Test and Document Certification of Mobile Health

Apps Will Regulation Kill Innovation? Self-Regulation: Devil's in the

Details

Regulation of Pharma Mobile Apps Survey

© 2013 Pharmaguy

Survey Results

30

© 2013 Pharmaguy

Self- Regulation of Pharma Mobile Medical Apps

31

The pharmaceutical industry must police itself with regard to development of medical apps; e.g., Issue “Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry.” Some suggested guidelines, include: Apps should cite the source of the data used by the app and

include contact information for reporting errors. Call this a “Mobile App Adverse Event Reporting & Tracking” system.

Apps must be rigorously tested & certified by a third-party to ensure quality and accuracy.

Apps should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.

© 2013 Pharmaguy

Social Media Pharma Marketing Readiness Self-Assessment -- http://bit.ly/RocheItaly

Overcoming Space Limitations in Social Media; http://bit.ly/fdasmSpace Use code ‘FDA397’ to get it FREE!

Accountability for Pharma Content on Social Media Sites;

http://bit.ly/fdasmAcct Use code ‘FDA497’ to get it FREE!

Solving the Social Media Adverse Event Reporting Problem;

http://bit.ly/fdasmAE Use code ‘AE495’ to get it FREE!

Pharma is Overcoming Social Media Hurdles: Assessing the

Three Biggest Obstacles to Success; http://bit.ly/SMhurdles Use code ‘SMhurdleFREE’ to get it FREE!

Resources

32

© 2013 Pharmaguy

Thank You!

33