The Pharmaguy Social Media Timeline™

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© 2014 Pharmaguy Pharmaguy’s Social Media Timeline “Those who cannot remember the past are condemned to repeat it” George Santayana, American writer “Constant Effort and Frequent Mistakes are the Stepping Stones to Genius” Elbert Hubbard, American writer Revised 19 June 2014

description

FDA has finally published several of its long-awaited social media guidelines for the drug industry, which has come a long way despite the long wait. This June, 2014 edition of the Pharmaguy Social Media Timeline documents some of the key events in pharma's social media quest, including its triumphs and tribulations.

Transcript of The Pharmaguy Social Media Timeline™

Page 1: The Pharmaguy Social Media Timeline™

© 2014 Pharmaguy

Pharmaguy’s Social Media Timeline

“Those who cannot remember the past are condemned to repeat it”

George Santayana, American writer

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

Elbert Hubbard, American writer

Revised 19 June 2014

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My Personal Timeline of Critical Pharma Social Media Activities

Pharmaguy is Chief Pundit at Pharmaguy.com

This Timeline begins in 2005, the year that

Pharma Marketing Blog was launched. Around that time and shortly thereafter,

Facebook, Blogger, YouTube, and Twitter became available to all and ushered in the

modern “social media” era.

For a more complete and up-to-date timeline with links to source documents, see my Google

Docs version here:

http://bit.ly/PG-SM-Timeline

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First Pharma Discussion Board

GSK’s QuestionEverything.com allowed consumers to ask questions and have an online conversation among themselves and with experts. GSK said the purpose of the site was to offer peer support and professional advice to dieters and to "dispel the many myths about dieting, exercise and fraudulent weight loss products.”

April 2006

In June 2007, GSK launched AlliConnect—the first pharma product branded Blog—to promote Alli, its newly approved over-the-counter weight loss pill.

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First Pharma Sponsored YouTube Video

GSK (UK) sponsors “My Dad has Restless Leg Syndrome” YouTube video, which includes a message at the end stating that “My dad is one of a Million people in the UK who suffer from Restless Legs Syndrome.”

October 2006

May 2008: Johnson & Johnson launches the first pharma YouTube unbranded Channel.

September 2008: FDA issues first pharma YouTube video warning letter to Shire Pharmaceuticals (Vyvanse).

February 2009: AstraZeneca launches "My Asthma Story," the First Rx (Symbicort) branded YouTube channel.

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Pfizer Collaborates with Sermo

October 2007

Sermo and Pfizer sign a deal where-by Pfizer gains access to the online physician community via surveys and sponsored con-tent. More importantly, Pfizer physicians can join Sermo and openly participate in online physician conversations as long as they identify themselves as employees of Pfizer.

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First Pharma Facebook Page

June 2008

McNeil Pediatrics—a division of J&J—launches ADHD Moms. “Now to be fair, this Facebook page, still isn’t all that interactive,” said Marc Monseau, a J&J spokesperson at the time. “Though visitors can download podcasts, articles and participate in instant polls, they can’t post coments to the wall on the page. What they can do, though, is use their own Facebook pages to connect with other ADHD Moms fans. It’s a baby step, to be sure...”

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FDA Sends 14 Notice of Violation Letters

April 2009

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

1 April 2009: Pharmaguy posted a fake press release announcing FDA guid-ance regarding pharma’s use of social media.

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Death of the “One-Click Rule”

“...there is no ‘official’ FDA one-click rule... there is a ‘received precedent’ that if you have one click from your brand site to the PI or labeling information, that is acceptable. Or call it ‘best practice’. Or call it just ‘common practice’.” − Jim Nail

FDA’s 14 warning letters put an END to the one-click “rule,” “received precedent,” “best practice,” or “common practice,” − Pharmaguy.

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UCB Embraces Adverse Events on Sponsored Discussion Board

!  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 report-

ing adverse events to FDA

June 2009

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First Rx Branded DTC Tweet!

June 18, 2009

I called this tweet “Sleazy Twitter Spam” We Are Still Friends!

Tweets are written by racecar driver Charlie Kimball who is is a

fully-branded Levemir spokesperson when in uniform.

March 29, 2009: @AstraZenecaUS was first to post tweets intended for HCPs and the press that mentioned a brand name drug (CRESTOR) & indications for which it was being studied (e.g., “reduce CV risk”).

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FDA Hosts Public Hearing on Internet & Social Media

November 12-13, 2009

! Accountability ! Fulfilling Regulatory Requirements ! Posting Corrective Information ! Links ! Adverse Event Reporting

 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.”

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Disgruntled Patient Shuts Down Sanofi-Aventis Facebook Page

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.

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First Pharma FB Page to Publish Comments

October 7, 2010

Published all comments before

reviewing, but reserved right to delete comments

that were offensive or mentioned ANY

product.

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First Pharmaguy Social Media Pioneer Award

October 19, 2010

Alex Butler, former Digital Strategy and Social Media Manager at Janssen & recipient of first ever Pharmaguy Social Media Pioneer Award, said:

“If a brand, company, person is that worried about comments in SM there is probably a deeper issue under the surface.”

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First Live Pharma Tweet Chat

February 16, 2011

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

Pharmaguy said, "This is quite gutsy of AZ considering that anyone can ‘join’ the chat simply by posting a message containing the #rxsave hashtag. And anyone can post messages about AZ drugs and mention side effects too even though AZ might say that it will not respond to questions about specific drugs.”

“OMG! AstraZeneca Hosts Twitter Chat & World Does NOT End!,” -- Pharmaguy

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First Hack of a Pharma Facebook Page

July 20, 2011

! Pfizer’s US corporate FB page broken into by “Script Kiddies.” Shut down for several hours over weekend.

! Admin password “guessed” by hackers after finding a LinkedIn page of an outside PR agency person who was responsible for creating or overseeing the page’s development

! Lessons:

"  Make sure your passwords are strong & protected

"  Hire competent outside agencies (PR vs Interactive?)

"  Have competent in-house FTEs oversee SM agencies monitor SM sites 24/7

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Pharma Phases Out Facebook Pages

August 15, 2011

! New Facebook Policy: Pharma is no longer be able to shut off comments to pages unless full prescribing info is included (for product pages)

! Among First to go: ADHD Moms

Did some pharmacos use this an excuse to shut down pages that were no longer effective?

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Pfizer’s Facebook Comment Fiasco

October 27, 2011

! Chapstick “slapstick” ad criticized for being sexist and/or anti-women

! Negative comments deleted without explanation

! People complain about comments being deleted

! A social media “death spiral” ensured said AdWeek

! Eventually (maybe too late!), Pfizer apologizes but tempers the apology by saying it only deletes “repetitive” & “spam-like” comments

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Allergan Employee Tweet Breaches PMCPA Code

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?

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FDA Publishes Off-Label Guidance

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”

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Novo Nordisk & Bayer on Pinterest

April 2012

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Pharma Invited to Edit Wikipedia Articles

June 13, 2012

! In an open letter, Bertalan Meskó, MD, founder and managing director of Webicina.com, advised pharma companies “to employ a Wikipedia editor if you want to make sure only evidence-based information is included in entries about your own products.”

! No takers as of January 2014

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Pfizer Does Not Give Up on Social Media Comments

June 18, 2012

! Registered visitors to Get Old site are encouraged to "Share your thoughts and experiences about getting old."

! Can post links, videos, photos, or stories

! Posts reviewed within 48 hours

! Includes posts from patient advocacy partners (e.g., Alzheimer’s Association)

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Congress Gives FDA Until July 2014 to Issue Social Media Guidance

July 10, 2012

! "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 Secre-tary 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.”  

 

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Roche Publicly Discloses Social Media Principles

August 16, 2012

“A significant, albeit, small step in the direction of corporate transparency, normally so difficult to achieve within the pharma industry but so essential if it is to regain the trust that will be crucial for its long-term survival…[yet] so few pharmas have publicly revealed their

social media policies. Why is the industry so reticent?” -- Len Starnes, Bayer

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Janssen Engages HIV Community on Tumblr

August 2013

! This may be the first use of Tumblr by a major pharmaceutical company.

! Janssen encourages visitors to “Share Your Story.”

! Submissions “will be posted within 1-5 business days.”

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First Pharma Twitter Chat Focused on a Medical Condition

September 2, 2013

Boehringer Ingelheim was the first pharma company to host an open, live Tweet Chat -- #ChatAFib -- around a specific medical condition.

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FDA Publishes First Official SM Guidance

January 14, 2014

! CDER publishes draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”

! Although the guidance is focused on when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for postmarketing submissions, it does offer some insights regarding FDA's thinking on regulating "interactive media.”

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FDA Guidance for Submission of Interactive Promotional Media

January 14, 2014

! Focus is on Accountability ! Issues

"  What Constitutes "Influence?”

"  Burdensome Paperwork

"  Placement of Ads on Independent 3rd-Party Sites - Off-Label “Adjacency”

"  PhRMA Questions Legality

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FDA’s CDER Publishes 2014 Guidance Agenda

January 31, 2014

! “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014”

! Regarding advertising/social media:

"  Character Space Limitations

"  Correcting Independent Third Party Misinformation

"  Use of Links

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Boehringer Publishes Tweet Chat Playbook

April 2014

“How pharma Tweetchats can drive healthcare innovation”

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FDA Publishes TWO Social Media Draft Guidances in a Single Day!

June 17, 2014

①  “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”

②  “Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”

“Regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.” – Tom Abrams, Director, OPDP

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! Social Media Pharma Marketing Readiness Self-Assessment http://tinyurl.com/caghnm

! Overcoming Space Limitations in Social Media http://bit.ly/fdasmSpace

! Accountability for Pharma Content on Social Media Sites http://bit.ly/fdasmAcct

! Solving the Social Media Adverse Event Reporting Problem http://bit.ly/fdasmAE

! Pharmaguy's Social Media Compendium http://bit.ly/pgsoccat

Pharma Social Media Resources

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