New Rules for New Media

John MackPublisher, Pharma marketing News &Pharma Marketing Blog

@pharmaguy on Twitter

johnmack@virsci.com

Presented at

DigiPharm EU 2010September 30, 2010 • London, UK

A Funny Thing Happened While Waiting for FDA Guidance

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Questions Addressed

What’s Up with New FDA Guidance?

What is the Drug Industry Hoping For?

While Waiting for “Goduidance,” What is the Industry

Doing?

Guidance or No Guidance, What Are Best Practices?

What Does This All Mean for EU Marketers?

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FDA’s “Good” Guidance Practices

Publish Intent in Federal Register.

Although NOT Required, Hold a Public Hearing.

Have a Public Comment Period.

Review Comments Submitted to Docket.

Issue DRAFT Guidance.

Collect & Review Comments on DRAFT Guidance.

Revise DRAFT Guidance Based on Comments, If

Necessary and Issue FINAL Guidance.

I have the “privilege” of being part ofFDA’s “sausage-making” guidance

process!

FDA’s November 2009 Public Hearing

“FDA, tear down this wall! The wallbetween pharma and the Internet.”

In April, 2009 -- soon afterFDA’s issuance of the

infamous “14 letters” -- Icalled for a public hearing in

support of guidance forInternet and social media

marketing by the drugindustry. The meeting washeld in November, 2009.

I participated as a panelist at the firstFDA hearing on the Internet in 1996 and

expected the same results afterpresenting at the second hearing.

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Who Made Presentations & Submitted Comments?

Over 70 presentations weremade - including TWO by me -

during 2 days of hearings in2009. In addition, 70

individuals, companies, andorganizations submitted one ormore comments to the docket.

Perhaps because so manyservice providers (“hired

guns”) made presentations,very few pharma companies

participated in the 2009hearing although they werewell-represented among the

commenters.

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1996 vs. 2009: No déjà vu All Over Again!

Instead of ensuring that ALLstakeholders were representedat the public hearing, as wasthe case in 1997, for the 2009

hearing, the FDA assignedspeaking spots on a first-come,

first-served basis. As aconsequence, industry

advocates, including health websites & search engines that

depend on pharma advertising,FAR outnumbered patients,consumers, and healthcare

professionals.

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Issues of Interest to FDA

Accountability

Fulfilling Regulatory Requirements

Posting Corrective Information

Links

Adverse Event Reporting

Rather than getting into details about ALL these issues, I will focus on justthree: Accountability, Fulfilling Regulatory Requirements, and AE Reporting.

Accountability

For what online communications are manufacturers, packers, or distributors accountable? Inparticular, 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 theinfluence of the companies marketing the products?

When marketer or agent sponsors thediscussion (eg, provides a specificgrant to independent 3rd-party hostsuch as a patient advocacy group tosponsor the discussion)

When marketer or agent paid for thecontent (eg, paid patients fortestimonials or otherwise providedcompensation)

When marketer or agent paid fordisplay ads to be run on specificdiscussion pages (eg, only discussionsrelated to the product advertised)

3rd-Party Independence

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Pharma Parses Accountability

Earned MediaNo control of content, therefore not accountable

Paid Advertising & Shared Social MediaAccountable for initial message, but not if content

modified independent of company at later date

Owned MediaControl of content & distribution means company is

accountable all the time

This schema waspresented by Abbott in its

comments submitted to thedocket. Lilly dividescommunications into

Advertising, Content, andDiscussion. Johnson &Johnson points out thatuser-generated content

“does not constitutelabeling or advertising.”

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Parameters for Correcting Misinformation

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

ONLY misinformation of real and imminentdanger to the public health (to bedetermined by company) should becorrected

ALL off-label claims—even if supportedby peer-reviewed medicalliterature—should be corrected)

Only off-label claims NOT substantiatedby peer-reviewed medical literature shouldbe corrected

Companies should not be burdened byFDA regulations requiring them to makecorrections about ANY productmisinformation published on 3rd-party sites

Posting Corrective Information

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Accountability: Best Practices

DISCLOSURE of involvement with or influence over 3rd-party social mediacontent should be prominently displayed alongside relevant content whenpossible.

Half of survey respondents agree

Each company should have a Public Social Media Policy (SMP) that includes anotice 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 itsproduct Web sites, each pharma company should have a public SMP that appliesto 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 ormodification of its approved content and make a best effort to remove or correctthe content. But they should only be REQUIRED to do so only for sites owned ordirectly sponsored by them.

PhRMA suggested thatmanufacturers wouldwelcome correcting

misinformation abouttheir products postedto 3rd-party sites suchas Wikipedia IF thesecorrections were NOT

subject to FDAregulation.

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SocialMediaAEChallenges

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

The amount of information from thesesources is potentially too vast to beprocessed economically (lack of resources)

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

The information is usually incomplete anddoes not meet the requirements forsubmitting a meaningful AER (notactionable)

There are many potential issues that won'tfully be known until the practice of monitoringsocial media for AEs is more prevalent(unknown issues)

Adverse Event Reporting

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AE Reporting: Industry CommentsRegarding Privacy Issues

PhRMA raised privacy issue: FDA should not force

manufacturers to seek personal health information from patients or

reporters in a public forum

Lilly also cited privacy issues and said “National and

international privacy laws …may preclude sponsors from

attempting to obtain follow-up information… any attempts to

request personal information create significant mistrust in any

company or other entity attempting to obtain that information”

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AE Reporting: Industry Comments

Novartis suggested that FDA redefine “identifiable reporter” as

“privately contactable” (e-mail address w/o name, phone number is

not suitable)

AstraZeneca suggested e-mail address or Facebook contact alone is

suitable

J&J proposed that the technology of the Internet be used to assist in

routing potential adverse events to the FDA

Abbott suggested FDA make available a user-friendly system

through which web users can report events directly to FDA as was

suggested by speakers at the public hearing

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Are There Solutions for Space Limitations?

Are there proposed solutions that may help address regulatory concerns when using social mediatools associated with space limitations or tools that allow for real-time communications topresent product information?

“A 1-click link to the PI or the AE's in thePI is more than sufficient, we are not ananny state! Give people the rightinformation and let them process it.”

“products can be assigned hashtags byFDA, for a Twitter example (eg #Chillax),and be required to use that hashtag in allTwitter communications related to thatproduct, so that FDA can easily review thepublic tweets. Not sure how the DMswould be monitored. Similar rules for otherspecific SM sites”

Regulatory Requirements

Speaking of Space Limitations…

I called this tweet“Sleazy Twitter Spam”

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

characters or less?

Challenge (Globally): How tomake it meaningful for patients

We’re Still Friends!

The combination of social media anduse of celebrity spokespeople is a

win-win for pharma.

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Google’s New Search Ad Format for Rx

Search advertising is a BIG deal for pharma industry, which wasshaken up by FDA’s infamous “14 letters.”

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What’s Up with Draft Guidance?

FDA “Promised” DRAFT Guidance by End of 2010

Just as I Predicted: FDA Will Issue Multiple Guidances Over Time

Rather Than ONE BIG Guidance

What Will FDA Tackle First?

I predict that FDA will address the “space limitations” issues involvedin social media such as Twitter and search advertising in its first

Internet guidance document, which may specifically “bless” Google’snew search ad format.

"What had been envisioned as a massive, all-encompassing guidance on Internet promotion isbeing retooled as multiple guidances to address specific issues in the online realm,"

said Tom Abrams, head of CDER at DDMAC. Abrams said the planned move from a singledocument covering all forms of online promotion -- such as social media, webpages and videos

-- to multiple, targeted guidances will help future-proof DDMAC's oversight of the web.

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While FDA Ponders the Issues, PharmaDives Into Social Media

Pharma and Healthcare Social Media Wiki*55 Twitter Accounts (excluding personal

accts)45 Facebook Sites35 YouTube Sites31 Brand-Sponsored Patient Communities19 Blogs

*Source: Dose of Digital Blog. As of May, 2010.

Updated in September 2010. Too many to keeptrack of. Many, however, do not qualify as

pharma sites or social media sites.

Got SM Swimmies?

This is what happens when you don’t implement a policy forhandling user-generated content.

S-A’s VOICES: First Case of “AE” Mishandling

S-A recently launched a “Diabetes Co-Star” FB page featuring movie actor and diabeticPaul Sorvino. Another case of combining celebrities and social media. While

comments are allowed, so far only comments from S-A have been published.

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UCB-Sponsored PLM Epilepsy Community

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

Goal: Generate patient-reported outcomes that may helpUCB better understand how patients live with epilepsy andhelp advance epilepsy care.

Provides disease tracking tools

Deployed a system for reporting adverse events to FDA

While many pharma companiesattempt to shy away from

participating in online patientcommunities due to AE reportingchallenges, a few are undeterredand seem to have figured it out.EU-based companies like UCB

lead the way here.

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J&J: Social Media & Crisis Management

“Best of luck in gaining theconsumers confidence back.”

“As a long time stockholder andformer employee, all I have to sayis that I’m terribly disappointedthat JNJ thought it was okay formy child to be put at risk. Stoptweeting and blogging and focuson what’s important.”

“The silence from J&J isoverwhelming.”

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BI on Facebook: Social Media & Targeted Ads

"Facebook does allow adsto be turned off in the rightrail for any pharma pagethat requests it. So, after

your blog post, werequested it. Best, John" --

John Pugh, Director ofCorporate Communications.

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These ads are not underBI’s control and are

targeted to ME accordingto my Web browsing

history, with which BImay not want its content

associated!

Janssen-Cilag on Youtube: AllowingComments & Likes

“Comments are reviewedbefore posting - in line withthe commenting policy onthe site. The vast majorityof comments have been

posted, Kind regards, Gary”-- Gary Monk, Product

Manager.

"Here's a hint for pharma.Nothing will go viral if you

don't allow 'Likes' orcomments. Guaranteed.” --

Jon Richman

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BI: An Integrated Social Media Campaign

Celebrity spokesperson

Live events

TV commercials

Web site

Facebook page

Twitter account

YouTube channel

Will it increase ROI?

Can this kind of integration be usedfor branded campaigns? Yes, seeNovo Nordisk’s Race With InsulinUS campaign.

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What Does This All Mean for EU Marketers?

Obviously, FDA guidance is applicable when you promote

directly to consumers in the US

You can get some useful ideas about BEST PRACTICES from

the presentations and comments submitted to the FDA by your

colleagues during the process. But only IF these ideas are

implemented correctly!

When all is said and done by the FDA, we may realize that

social media really fits BETTER with the European way of

pharma marketing, which focuses on disease awareness and

direct-to-patient response only upon request by the patient.

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Resources

www.FDAsm.com

FDA's Regulation of Drug & Device Promotion via the Internet & Social Media --

a detailed summary of PMN survey results & comments as submitted to the FDA;

http://bit.ly/fdasmSurvey. Use code ‘2F28AD’ to get it FREE!

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!

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