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Copyright 2012, Morgan, Lewis & Bockius LLP
Social Media and Medical Device PromotionWhat’s New?
AdvaMed / MTLI Advertising & Promotion of Medical Devices
Learning Institute Program
November 7, 2012Washington, DC
Kathleen M. [email protected]
Washington, DC
Audience Metrics
• Does your Company have/sponsor:
• Facebook page?
• Twitter account?
• Patient chatroom?
• Do you follow your own Company’s Facebook/Twitter account?
• Yes
• No
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Audience Metrics
• Do you have a LinkedIn profile?
• Do you have a personal Facebook page?
• Yes
• No
• Do you mention your Company on your Facebook page?
3
Social Media Market Realities
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What are the Market Realities?
• One in three consumers who use the internet to research health information use social media.
• Social media ad spending is predicted to hit $8.3 Billion by 2015.*
• In a 2011 MassMedic survey of 70 medical device companies.
• 23% said companies actively use social media
• 40% said company used it “a little but not a lot”
• 16% said no use
• 50% have social media policy *Source: Social Media Use by Fortune 100 Companies, Burson-Marsteller, July 29, 2009.
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What are the Market Realities?
• 25% of all internet time is spent on social media.• Americans spend more time on Facebook than
any other social media site.• Close to 40% of social media users access it
through their mobile apps.• Internet users over 55 are driving the use of
social networking mobile apps.• 53% of social network users follow a brand*
*Nielsen “State of the Media—Social Media Report (3Q 2011)
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What are the Market Realities?
• Top 5 US social network sites, total minutes (in billions)*
• 53,457,258 facebook
• 723,793 blogging
• 623,525 tumblr
• 565,126 twitter
• 325,679 LinkedIn
*Nielsen (2011)
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What are the Market Realities?
• Patients are forming their own online support groups to manage health conditions and information• www.patientslikeme.com
• cancerforum.com
• www.inspire.com
• www.childrenwithdiabetes.com
• www.medhelp.org
• www.MediGuard.org
• Patients looking to rate healthcare products/services on social media sites like Yelp!
• Patients share photos and videos, e.g., on YouTube, Pinterest
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What are the Market Realities?
• 60% of physicians are using social media to assist medical practice-many prefer “closed communities”
• www.sermo.com
• within3.com
• www.ozmosis.com
• www.medscape.com/connect
• www.Doc2Doc.com
• www.relaxdoc.com
• www.healtheva.com
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What are the Market Realities?
• 64% of physicians have changed a treatment based on Sermo
interactions.
• Approximately 35% of high end users of Sermo would be willing
to replace activities such as KOL meetings, conferences, poster
presentations and sales reps visits with Sermo live events.
• 74% of physicians perceive life sciences company-sponsored
educational events on Sermo to be useful.
• Even “no see” physicians would interact with life sciences
companies on Sermo.
• Source : Deloitte, Social networks in the life sciences industry, Dec. 14, 2010
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What are the Market Realities?
• 24% of recently surveyed physicians use social media daily to scan for new medical information
• 14.2% of physicians contribute to social media sites daily for medical-related topics
• Majority of physicians are still not completely comfortable with open social media sites
• Oncologists appear to be the highest –using sub specialty of physicians.*Journal of Medical Internet Research, “Understanding the Factors Influencing the Adoption and Use
of Social Media by Physicians” (Sept. 2012)
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What are the Market Realities?
• AMA acknowledges benefits of social media use:The Internet has created the ability for medical students and physicians to communicate and share information quickly and to reach millions of people easily. Participating in social networking and other similar Internet opportunities can support physicians’ personal expression, enable individual physicians to have a professional presence online, foster collegiality and camaraderie within the profession, provide opportunity to widely disseminate public health messages and other health communication. Social networks, blogs, and other forms of communication online also create new challenges to the patient-physician relationship.
AMA Policy: Professionalism in the Use of Social Media (2012)
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What are the Market Realities?
• Companies are responding to physicians and consumers by using integrated social media campaigns including:
• blogs, microblogs (twitter),
• Patient chat rooms
• buttons and badges
• online videos
• podcasts
• social networking sites (Facebook, Sermo, Dailystrength, MomCentral)
• widgets, wikis
• Regulatory agencies like FDA and FTC engage in information exchange through social media e.g., U.S. FDA @US_FDA ; @FDA_Drug_Info; FDA widgets: www.facebook.com/FDA; www.flickr.com/photos/fdaphotos
• Library of Congress archiving all tweets: 55M/day sent by Twitter.
Challenges
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Challenges to Use of Social Media Sites
• Problematic third party comments• Negative / false comments or information about product or
service
• Comments that include adverse event information
• Off-label comments
• Comments about competitor products—either inaccurate or comparative claims that are off-label
• Frequency, speed and specificity of Company responses• Control of employee participation and responses
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Challenges to Use of Social Media Sites
• Combatting false information by third parties about your product off your site
• E.g., Michelle Bachmann public comment about adverse effect of Merck product Gardasil
• How should company correct such information in view of possible negative public health impact?
• How far must company go to substantiate false information?
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®
Challenges to Use of Social Media Sites
• Spontaneous comments by third parties on company social media site which cannot be pre-reviewed, i.e., Facebook problem
• Possible Approaches• Don’t participate in/sponsor Facebook or similar sites
• Allow consumers not to post spontaneous comments, but to only “like” Company content
• Allow spontaneous comments but monitor and delete them (either through company monitoring or auto-alert based on specified search terms; 24/7 or less)
• Create modified Facebook-like wall which allows for pre-posting review or create forum tabs on Facebook which redirect third party to monitored site
• Alert third parties to the review mechanisms to manage expectations about posting policies
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Challenges to Use of Social Media Sites
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• Company participation in consumer-driven sites presents special challenges
• E.g, Realself.com presents consumer comments about and pictures of plastic surgery, and potentially includes significant off–label discussion by HCPs and patients
• FDA one click policy and policy on reporting AEs which come to attention of company discourage / create potential risk for company participation in this type of site
Uncertainty
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What will FDA’s Position be on the Use of Social Media?
• Nobody Knows…. BUT FDA says:• “Policy and guidance development for promotion of FDA-regulated medical products
using the Internet and social media tools are among our highest priorities.”
• Social media guidance will address:
• Responsibility of various parties in the downstream distribution of on-line information
• Use of links
• How to correct msinformation posted on a third part site
• Adverse event/MDR reporting
• How to present risk information in limited space, i.e., Twitter problem
• And Congress Says:
• DRAFT NEW Guidance on Social Media by June 2014 (2012 User Fee Legislation) but no legislative hammer included (Section on 1121 of Food and Drug Administration Safety and Innovation Act)
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Why has FDA Delayed Publication of Social Media Guidelines?
• Competing Crises.• This is a difficult guideline to draft.• Social media is outside of FDA’s comfort zone of
expertise.• Social media is a messy gemish
• Abbreviated messaging to consumers and HCPs
• Social media is participatory, with parties over which FDA has no or limited jurisdiction
• It produces real-time, rapid information which is impossible for FDA to access, monitor, and control
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FDA Enforcement Against Social Media
• Despite the lack of guidance, FDA continues to take enforcement action against social media use, mostly against drug promotion.
• May 2012 — Warning Letter issued to device manufacturer, ThermaSolutions stating that video links, including clip from Grey’s Anatomy, on third party website linked to company website, and company Twitter posts, adulterated and misbranded the company’s device.
• February 2012 — FDA issued a large number of Warning Letters to dietary supplement internet distributors identifying Twitter references as misleading and changing the regulatory status of the product
• May 2011 — Warning Letter issued to Warner Chilcott based on 60 second YouTube video made by sales rep in office of doctor because there was no risk information included in video.
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FDA Enforcement Against Social Media
• March 2011 – Warning Letter to 2035 Inc. and QLaser Healing Light, LP based on off-label claims discussed in embedded videos and YouTube channel.
• January 2011 – Warning Letter issued to Breast Health Imaging Centers concerning off-label claims on mammography in embedded videos and YouTube.
• July 2010 — Warning Letter issued to Novartis about use of Facebook share widget because shared content did not adequately address risks through use of hyperlink to risk information.
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What is FDA’s Current Position on the Use of Social Media?
• FDA’s current policy--social media promotion is the same as traditional advertising for purposes of regulation, i.e.,• Any reference to the product and attribute must include in the message
comprehensive information about the product’s risks
• Express and implied claims cannot be false or misleading
• Implied claims are created through use of graphics, music, color, themes
• FDA looks at the net impression created by the promotion
• The key is to figure out how to present risk information and limit possible modification of messages by third parties.
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What Might Affect FDA’s New Policy on Social Media?
• 2012 Congressional Mandate• 2012 CDRH Withdrawal of DTC Marketing
Guidance• 2011 Draft Guidance on Unsolicited Requests
• Broad concept of “solicited” questions/comments
• Broad concept of “public” forum
• Broad concept of being “linked” to third party comments and therefore being “responsible”
• Note PhRMA has submitted request that these guidelines not be in lieu of specific social media guidance
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What Might Affect FDA’s New Policy on Social Media?
• 2009 FDA Draft Guidance on Presenting Risk Information for drugs and medical devices• The guidance states that FDA applies the same principles of risk
disclosure in advertising to all promotional pieces, regardless of medium used.
• FDA will evaluate claims in promotion from the “reasonable consumer acting reasonably in the circumstances standard.”
• Claims in promotion can be subject to multiple interpretations and none of them can be misleading.
• FDA recognizes a difference between the knowledge and experience of HCPs and consumers.
What Might Affect FDA’s New Policy on Social Media?
• 2012 DTC TV ad review process for drugs, i.e., need for FDA review of substantiation for claims, concepts and “creative themes”, and verification of status of all HCP and consumer endorsements/testimonials.
• March 2010 FDA proposed regulation on major statements for DTC ads for drugs in TV and radio.• Major statement must be presented in clear, conspicuous and
neutral manner under FDAAA.
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What Might Affect FDA’s New Policy on Social Media?
• FDA proposed principles for risk disclosure in DTC drug ads:• Language must be readily understandable by consumers.
• Any audio is understandable in terms of volume, articulation, and pacing.
• Size and contrast have to be adequate.
• There can be no distracting representations or sounds, especially if they go to benefits of the product.
• FDA will be “flexible”.
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What Might Affect FDA’s New Policy on Social Media?
• FTC’s position on disclosures in social media--Guidelines for determining if disclosures are clear and conspicuous • Both audio and text of disclaimer are necessary.
• Must be easily read—print size and contrast are important.
• No competing audio/graphics during disclaimer.
• Pacing/duration is important and risk information should be provided at relevant times throughout ad.
• Volume, cadence, placement of disclaimer are important.
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What Management Affect…
• FTC 2012 proposal to revise Dot.com Disclosure guide for digital disclosures• Context of claim matters—there cannot be a one-size fits all
disclosure, only factors to consider
• Media platforms must adapt to the law, not vice versa—some claims just may not be able to be made on social media
• Using a hyperlink for disclosures may be acceptable but it must be eye-catching, and its location is critical
• Disclosure icons and hashtags maybe acceptable and adequate but the effectiveness may depend on consumer understanding
• Word of Mouth Marketing Association (WOMMA) Social Media Disclosure Guide (August, 2012)
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What Might Affect FDA’s New Policy on Social Media
• FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising --Dec. 2009• Apply to testimonials on social media (blogs, tweets, videos, etc).
• Must be truthful and non-misleading.
• Must reflect the typical user’s experience or if not, state what the generally expected experience would be.
• Any relationship between the endorser and the company must be disclosed (free goods, payment, commissions for sales, etc) conspicuously, i.e., not through a separate link or button.
• Disclosure about compensation also applies to tweets—use #paid ad or #ad, #paidspon.
• Corporate sponsors must have adequate training and monitoring mechanisms in place for product claims made in social media.
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The Courts’ View of FDA’s Regulation of Advertising/Promotion
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The Courts’ View of FDA’s Regulation of Advertising/Promotion
• Product advertising and promotion is commercial speech— it does not receive the highest level of First Amendment constitutional protection but has some protection.• Note – scientific/academic speech is afforded a higher level of protection
– strict scrutiny.
• Courts have articulated several principles under First Amendment analyses for commercial speech.• Prior restraint is presumptively unconstitutional.
• Keeping consumers ignorant of information is not an acceptable basis for significant regulation of commercial speech.
• Disclosure often can cure concerns about whether speech can be misleading or inaccurate.
• Courts outside of DC Circuit have restrained FDA’s power to limit commercial speech
Social Media and Device Promotion
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FDA Regulation of Social Media for Device Promotion
• FDA regulates “labeling” of all devices, advertising for the very small universe of restricted devices.
• FTC regulates all device advertising, which can be evidence of new/different use and give rise to prohibited act under FFDCA, false claim, and new regulatory filing.
• FDA extends its regulatory reach to advertising through broad definition of “labeling,” and links between labeling and advertising (e.g., common use of website address in both).
• Not clear if FDA considers social media labeling or advertising.
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How to Manage the Uncertainty without FDA/FTC Guidelines
• Do you know where your “content” is?
• Responsible for content on your Company’s sponsored sites, sites it supports, its employees’ use of content.
• “Patrol your own House” -- monitor and correct content of third parties (HCP and consumers) on Company sites.
• Monitor sites/contacts from HCPs and consumers for adverse event information / MDRs.
• Have a company policy on correcting misinformation of which Company become aware—and have a corporate policy on what constitutes “awareness”.
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How to Manage the Uncertainty without FDA/FTC Guidelines
• Carefully provide informative and understandable risk information; evaluate ways to link/provide information.
• Consider transparency quotient of all messaging.
• Routinely test and document messaging impact of social media content as defense to FDA and private litigation.
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How to Manage the Uncertainty without FDA/FTC Guidelines
• Prepare policies for:• Appropriate uses of social media for product promotion, and functional
responsibility within the organization for social media use.
• Physician and patient testimonials, celebrity endorsements, authorized product placements.
• Correcting misinformation on third-party sites, and system for documenting attempts to correct.
• Employee use of social media to promote/discuss products.
• HCP consultants’ use of social media to discuss company products.
• Privacy / other protections for use of HCP and consumer data from social media sites.
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How to Manage the Uncertainty without FDA Guidelines
• Understand that use of social media for promotion may evoke:
• Personnel issues
• Federal/state enforcement activity
• Competitor complaints/challenges through FDA/NAD/Courts under Lanham Act
• Plaintiff claims/litigation.
• Check insurance coverage for economic injury from social media activity.
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Copyright 2012, Morgan, Lewis & Bockius LLP
Questions?Questions?
Kathleen M. Sanzo, [email protected]
Washington, DC
