navigating advertising and promotion through social media jennifer de camara, assistant general...
TRANSCRIPT
Navigating Advertising and Promotion through Social
MediaJennifer De Camara, Assistant General Counsel,
Johnson & JohnsonDale Cooke, Owner, PhillyCooke Consulting
Anne Maher, Partner, Kleinfeld, Kaplan & Becker LLPModerated 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• Concern over the state of the guidance development process resulted in 57 guidances being withdrawn, including three ad-promo guidances– Disease Awareness Guidance– Accelerated Approval Promotion Guidance– Electronic Submissions Guidance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 CamaraAssistant 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.
8
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
9
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
10
Correcting Misinformation Considerations
• Setting the threshold to correct• Who makes the determination• Process for providing correction• Documentation• Other considerations
– “Control”– Employees– Investigational products– Competitive products– Different languages and regions
11
Paid Search for Boxed Warning Products
• Business goals
• In the absence of complete regulatory clarity…
• Executional considerations– Website standards– IT preparedness– Benchmarking
12
Vanity URLs
13
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
64%
Yahoo!
13%
Bing
21%
Other
3%
http://www.comscore.com/Insights/Market-Rankings/comScore-Releases-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 requirements1.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/reminder-like-promotions.htmland http://regulatoryrx.blogspot.com/2015/06/google-search-engine-marketing-changing.html
Google 2015 Updates
• Black box ad format discontinuedEffective date: July 20, 2015
• Redirecting ads vanity URL changesEffective 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
• Option 3a: Prescription treatment
• Option 3b: Prescription device
Destination page will still be under control, but the display URL must be one of Google’s specific options.
Key Takeaways
• Platforms will changeCompany-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
Navigating Advertising and Promotion through Social Media
Anne V. MaherPartner
Kleinfeld, Kaplan & Becker
FDLI’s Advertising & Promotion Conference 2015Renaissance Hotel Washington DCOctober 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)
Questions?
46