Transcript Slides

Navigating Advertising and
Promotion through Social
Media
Jennifer De Camara, Assistant General Counsel,
Johnson & Johnson
Dale Cooke, Owner, PhillyCooke Consulting
Anne Maher, Partner, Kleinfeld, Kaplan & Becker LLP
Moderated by: John Kamp, Executive Director,
Coalition for Healthcare Communication; Of Counsel,
Wiley Rein LLP
The Larger Environment
• 20th Century Cures bill passed House without
One-click provision
– Contains three communication provisions
– Senate counterparts moving slowly
• Draft One-click provision by Congressman
Billy Long (R-MO) lacks co-sponsors and
legislative vehicle
• PDUFA VI bill discussions begin
– Likely the next vehicle for social media and other
amendments
Recent Developments
• ObamaCare fully implemented
– New patient coverage increases scripts
• Sunshine Act Reporting, “Open Payments
Program” and first public data released
• First biosimilar approved by FDA
– No guidance from agency on naming (with
obvious impact on promotion)
– No guidance (or declared intention to produce
guidance) on marketing of biosimilars
Congressional Attention
• In addition to the legislative items discussed
earlier, there has been significant attention
from Congress to FDA operations
• Concern over the state of the guidance
development process resulted in 57
guidances being withdrawn, including three
ad-promo guidances
– Disease Awareness Guidance
– Accelerated Approval Promotion Guidance
– Electronic Submissions Guidance
New Guidances
• New Brief Summary Guidance (including
August revision)
Coming soon...
• New Disease Awareness Guidance (see
previous slide)
• Additional social media guidance
Off-Label Discussion
• Amarin and Pacira cases create regulatory
uncertainty
• “False and Misleading” still a potent
regulatory tool for FDA
• Off-label meeting (not yet scheduled)
• Still waiting on off-label guidance promised
in 2014, now driven by court actions
Navigating Advertising and
Promotion through Social
Media
Jennifer De Camara
Assistant General Counsel
Johnson & Johnson
Disclaimer
The views and opinions expressed in the
following slides are my own and should not
be attributed to my company.
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General Observations
• Be crisp on your business goals in social
media
• In the absence of complete regulatory
clarity:
– Don’t engage or
– Develop well-reasoned positions consistent with the
spirit of what you do know
• Never underestimate executional
considerations
– Build in quality principles up front
– Then look and see how you are doing
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Adverse Event Reporting
Considerations
• Think globally
– Ex-US standards sometimes exceed details in US
requirements
• Consider possible intake points and
assess them consistently
– Duty to monitor?
– Does the company have access to the data?
– Is the data likely to generate AE reports?
• Consider what internal business functions
need coordination and connectivity
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Correcting Misinformation
Considerations
•
•
•
•
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Setting the threshold to correct
Who makes the determination
Process for providing correction
Documentation
Other considerations
–
–
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–
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“Control”
Employees
Investigational products
Competitive products
Different languages and regions
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Paid Search for Boxed Warning
Products
• Business goals
• In the absence of complete regulatory
clarity…
• Executional considerations
– Website standards
– IT preparedness
– Benchmarking
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Vanity URLs
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Lessons from Google
Search Updates
Dale Cooke
PhillyCooke Consulting
[email protected]
@PhillyCooke
Importance of Search
• 87% of U.S. adults use the internet
• 72% of internet users looked online for
health information
• 77% of online health seekers began at a
search engine
http://www.pewinternet.org/fact-sheets/health-fact-sheet/
Google Dominates Search
Google
64%
Yahoo!
13%
Other
3%
Bing
21%
http://www.comscore.com/Insights/Market-Rankings/comScoreReleases-August-2015-U.S.-Desktop-Search-Engine-Rankings
FDA Enforcement
FDA Enforcement
Post-2009 Compliant Promotion
1. Disease Awareness Promotion
2. Reminder Ads
3. Redirecting Ads
Google 2009 Black Box Option
Reminder-like Ads
Apply to drugs with black box warnings
Four requirements
1.Brand name (if applicable)
2.Generic name and/or active ingredients
3.“Please see…” statement
4.Provision of PI or Brief Summary immediately
accompanying the advertisement
For more on reminder-like ads, see http://regulatoryrx.blogspot.com/2014/10/reminderlike-promotions.html
and http://regulatoryrx.blogspot.com/2015/06/google-search-engine-marketingchanging.html
Google 2015 Updates
• Black box ad format discontinued
Effective date: July 20, 2015
• Redirecting ads vanity URL changes
Effective date: January 2016
Black Box Ad Options
Standard ad units
Existing mobile ads
Black Box Ad Options
Standard ad units
Existing mobile ads
Using sitelinks to create
second destination link
NOT using sitelinks to create
second destination link
Redirecting/Vanity URL
Changes
• Option 1: Company
• Option 2: Company.com
• Option 3a: Prescription treatment
• Option 3b: Prescription device
Redirecting/Vanity URL
Changes
• Option 1: Company
• Option 2: Company.com
Destination page will still be
under control, but the
display URL must be one of
Google’s specific options.
• Option 3a: Prescription treatment
• Option 3b: Prescription device
Key Takeaways
• Platforms will change
Company-specific policies matter
• 30-day notice is a luxury
• Mobile is the new standard
• One link must suffice for promotion &
regulatory requirements
Speaker Bio
Dale Cooke is the owner of PhillyCooke Consulting, which provides advice and
training to companies about using 21st century technologies to communicate
about FDA-regulated products while remaining compliant with FDA regulations
written in the 1960s. Dale has worked with more than 30 pharmaceutical and
medical device clients around the world. His insights have been featured in the
Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec,
and others. He also serves on the faculty of the University of California San
Francisco’s American Course in Drug Development and Regulatory Sciences
program. Dale is the author of Effective Review and Approval of Digital
Promotional Tactics, which is part of FDLI’s primer series.
Contact Info:
PhillyCooke.com
@PhillyCooke on Twitter
[email protected]
Navigating Advertising and
Promotion through Social Media
Anne V. Maher
Partner
Kleinfeld, Kaplan & Becker
FDLI’s Advertising & Promotion Conference 2015
Renaissance Hotel Washington DC
October 1-2, 2015
Topics
• Highlights of FDA Draft Guidances on Social
Media
• Adverse Even Reporting and Social Media
Background on 2014 Draft Guidances
• November 2009 hearings – 1st attempt since 1996
hearings to gather information on using the internet to
promote medical products
• The two main issues:
– How do FDA’s labeling and advertising regulations
relate to certain internet/social media-related activities
– What are the manufacturers’ responsibilities for
monitoring and subsequently reporting AEs identified
on the internet and/or through social media tools
Responding to Unsolicited Requests
for Off-Label Info
• Firm’s public response to public unsolicited request
for off-label info about its named product should be
limited to providing firm’s contact info and should
not include any off-label info
• Firm scientists can respond directly to individual with
non promotional, balanced info, including
– FDA-required labeling,
– prominent statement that use is not FDA
approved/cleared
Responding to Unsolicited Requests for Off-Label Information
About Prescription Drugs and Medical Devices (June 2011)
Postmarketing Submissions of
Interactive Promotional Media
• Outlines considerations for determining if interactive
communications are subject to postmarketing
submission requirements
• Provides practical advice on how to meet the
requirements given the potential volume that is
continuously posted and shared in real time online
Fulfilling Regulatory Requirements for Postmarketing Submissions of
Interactive Promotional Media for Prescription Human and Animal Drugs
and Biologics (Jan 14)
Postmarketing Submissions of
Interactive Promotional Media (con)
• Firms are responsible for submitting product
promotional communications on sites that are
“owned, controlled, created, influenced or operated
by, or on behalf of, the firm.”
• Examples of influence: “if firm collaborates/has
editorial, preview, or review privilege over content”
Postmarketing Submissions of
Interactive Promotional Media (con)
• A firm is responsible for UGC generated by
employee/agent acting on behalf of firm
– Paid speaker, medical liaison, blogger, sales rep
• Not responsible for UGC that is truly
independent of the firm (“not produced by, or
on behalf of, or prompted by the firm”)
– Even on firm-controlled venues
Correcting Misinformation
• Guidance on how to correct misinformation in UGC
on 3rd party or company sites
• VOLUNTARY - Guidance on how to correct IF firm
chooses to
• Brands may host open conversations on company
owned sites without being responsible for content
Internet/Social Media Platforms: Correcting Independent
Third-Party Misinformation About Prescription Drugs and
Medical Devices (June 2014)
Correcting Misinformation (con)
• Any corrections must be relevant, disclosed,
non-promotional, and include a link to
appropriate product information
• If firm opts to correct, not required to correct
every instance of misinformation
• Firms not required to monitor corrections once
posted
• Required on firm-controlled sites: prominent
statement that firm did not create/control UGC
Takeaways on Social Media
Guidances
• Helpful in saying
– Firms only responsible for content they produce
or sponsor on behalf of their brands, and
– not responsible for UGC even on their own sites if
they don’t exercise control over that content
• Not always clear on what “exercising control
or influence” means
– E.g. ad review privilege given as example
Takeaways on Social Media
Guidances (con)
• Do not inform how to run effective and compliant
postmarketing surveillance activities on online
content for which firms are responsible
• Do not provide a Guidance on firms’ responsibilities
for monitoring and reporting online discussion of
AE
Adverse Event Reporting and
Social Media
• At 2009 hearings, consensus was most UGC on social
media did not contain all 4 elements required for a
reportable AE – i.e., identifiable patient, identifiable
reporter, suspect drug or biological product, an
adverse experience or death suspected to be due to
the suspect product
• Neilson survey to quantify incidence of AE in
consumer generated discussion – only 1 message in
500 contained all 4 criteria necessary to trigger an
AER
Adverse Event Reporting and Social
Media (con)
• Consensus at 2009 hearings: FDA should
improve the current surveillance systems in
place
– Medwatch form should be simplified, syndicated
and embedded across web
• FDA should work with online health firms to
develop tools to facilitate its collection of
AERs
Adverse Event Reporting and Social
Media (con)
• Today, pharma/device companies engagement with
social media is less than other consumer product
companies, although increasing*
– Partly due to the regulatory uncertainty of how
far they must go to track down the required
elements of an AE
– Partly to avoid the investment in and regulatory
burden of a formal social media strategy
*Engaging Patients Through Social Media. Report by the IMS
Institute for Healthcare Informatics. January 2014.
FDA and AERs
• In February 2014, FDA solicited bids from companies
to conduct real-time monitoring and analyses of a
representative sample of social media websites
• Object: to inform and evaluate FDA risk
communications
• To provide surveillance for early detection of adverse
events and food borne illness
FDA and AERs (con)
• June 2015, FDA announces partnership with
PatientsLikeMe, an online patient community that
connects people with same disease/condition
• The patient generated real-world data can supply
information to patients, researchers, pharmaceutical
companies, etc.
• 110,000 AE reports on 1,000 different medications
that FDA can access in addition to its existing data
from e.g. Medwatch and the Sentinel Initiative
Thank you!
Anne V. Maher
Kleinfeld, Kaplan & Becker
1850 M St, NW
Washington, DC 20036
202-223-5120
301-332-1819 (cell)
[email protected]
Questions?
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