Navigating Regulatory Issues of Social Media in Healthcare
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Navigating Regulatory Issues of Social Media in Healthcare

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Larry Weber of W2 Group, Marc Reisler and Michael Manthei of Holland & Knight and Joe Shields of Pfizer discuss the ways marketers in the health care industry can successfully navigate regulatory ...

Larry Weber of W2 Group, Marc Reisler and Michael Manthei of Holland & Knight and Joe Shields of Pfizer discuss the ways marketers in the health care industry can successfully navigate regulatory issues and maximize their online presence.

This webinar discussed topics that are top-of-mind for health care marketers, such as:
1 - What is the FDA's position on using social media to market FDA-regulated products?
2 - What privacy issues should marketers be aware of when using social media?
3 - Who has liability for social media content?
4 - Should pharmaceutical and medical device companies have a social networking policy?

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Navigating Regulatory Issues of Social Media in Healthcare Navigating Regulatory Issues of Social Media in Healthcare Presentation Transcript

  • Navigating Regulatory Issues of Social Media in Healthcare Nov. 19, 2009 #SMHC
  • Today’s Speakers Larry Weber Joe Shields Chairman Product Director, Consumer Marketing Digital Influence Group and & Strategy Integration Racepoint Group Pfizer Michael Manthei Marc Reisler Partner Partner Holland & Knight Holland & Knight 2 2
  • Agenda • Larry • Joe • Michael and Marc • Q&A – type in your questions for the panel #SMHC 3 3
  • About Us Full service digital agency that is social media at its core A global public relations agency that helps clients harness the power of both traditional and social media to build and protect reputation and drive business A global law firm with one of the largest Health Law & Life Sciences Practices in the U.S. 4 4
  • Introducing Larry Weber Chairman Digital Influence Group and Racepoint Group @thelarryweber 5 5
  • 61% of U.S. Adults Look Online for Health Information Sources of information American adults turn to for information or assistance in dealing with health or medical issues: Ask a health professional, such as a doctor 86% Ask a friend or family member 68% Use the Internet 57% Use books or other printed reference material 54% Contact their insurance provider Source: Pew Internet & American 33% Life Project 2009 6 6
  • Impact of Online Health Information Affected a decision about how to treat an illness or condition 60% Changed their overall approach to maintaining their health or the health of someone they help take care of 56% Led them to ask a doctor new questions, or to get a second opinion from another doctor 53% Source: Pew Internet & American Life Project 2009 7 7
  • The Problem Current regulations Manufacturers Public is deprived treat web same as reticent to engage access to valuable offline media online information online 8 8
  • Understanding Search 9 9
  • The Solution • FDA should adopt policies that encourage manufacturers to provide consumers with complete information. – Don’t over-regulate the communications revolution of our time. • Transparency is the key to freeing up information flow. – Differentiate between paid and unpaid links – Make source of information clear 10 10
  • Introducing Joe Shields Overcoming Pharma’s Social Awkwardness Joe Shields Product Director, Consumer Marketing & Strategy Integration Pfizer 11 11
  • Socially Awkwar d 12 12
  • Why Pharma Is Socially Awkward • With social media, pharma is confused about: – Its purpose – How the current regulations apply – Risks, rewards & measurement – How to review & approve tactics – The technologies – Who internally is responsible for managing it 13 13
  • For Pharma, Why Be Social? • Compliance • Corporate comms • Investor relations • Media relations • Issues management • Product promotion • Market research • Customer service • Customer demand • Competitors • Etc. 14 14
  • Free vs. Regulated Speech FDA / DDMAC 1st FTC AMENDMENT 15 15
  • Accountability Continuum • QUESTIONS: How long do you invest in a new idea before requiring at least some accountability? Where do Social Media initiatives fit on this continuum? No idea Proven, repeatable ROI Uncertain risks Uncertain rewards 16 16
  • Static Review & Approval Process • The role of the Company is to support Marketing, not the other way around • Yet in most cases, Marketing bends to the MRL review & approval process in pharma. This process tends to be: – Paper based – Linear – Slow – Consensus & committee-based – Risk-averse 17 17
  • Technology Moves Faster than Guidance • Explosion of new technologies rapidly creating buzz & increasing scale • Collision of mobile + search + social + immediacy • Difficult for advertisers to know where to place their bets • Some technologies challenge basics of regulated communication, i.e., open text, mashups, character limits 18 18
  • Organizational Support Varies for Social • Doesn’t neatly fit in Marketing, Public Affairs, Investor Relations, Media Relations, IT, Innovation, Corporate Communications, Privacy Office or eMarketing • Who plans, manages, staffs & pays for it? 19 19
  • will u still friend me tomorrow? 20 20
  • Engagement Is not Optional Anymore Pharma has a • RIGHT to engage • NEED to engage • RESPONSIBILITY to engage 21 21
  • Navigating the Next Few Months • Understand if & how Social can help your business • Figure out who in your company is in the best position to monitor & manage it • If it makes sense, pilot a few tactics • Be prepared to respond to additional guidance from FDA & internal review teams in 2010 22 22
  • Introducing Michael Manthei and Marc Reisler Michael Manthei Marc Reisler Partner Partner Holland & Knight Holland & Knight 23 23
  • Why the Law Makes Pharma Socially Awkward Communication Decency Act No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider AND right to filter offensive content. FDA Labeling and Advertising Rules Create, influence or control communication about a product 24 24
  • Control Continuum No Control Full Control • User generated • Company Generated • Real time • Internal review • No internal review • Form 2253 • Third party sites • Full review and edit of user content 25 25
  • The Awkward Question Is mere ownership of social media site enough to trigger FDA authority? • Entirely user generated, real time content • Corrections • Use of links • Adverse Events • What if you filter • What if you join the conversation 26 26
  • Avoiding the Awkward Question • Ignore Social Media • Grants to third party sites • Keep it internal • Participate, but don’t mention products 27 27
  • Nov. 2009 Social Marketing Hearings Purpose: “Gather testimony and written comments intended to help guide the FDA in making policy decision on the promotion of regulated products using the Internet and social media tools.” Topics: 1. Responsibility for online communications 2. How to fulfill regulatory requirements • Space limitations • Real-time communications? 3. Posting of corrective information on third party websites 4. Rules for use of links 5. Adverse event reporting 28 28
  • Results: Long on Comments… Short on Solutions • Everyone LOVES the Internet – FDA: Yeah, we know that! • Confirmed that companies are avoiding social media – Lilly Testimony • Companies should never be responsible for 3d party content – No control • Create a universal, FDA approved “Safety Symbol” • Require hashtag in Tweets • Roll-over and pop-up safety information • Post NOV sponsored links are less relevant and less transparent! – Opposite of what FDA wanted! – Click through rates have dropped significantly • Google proposed standard sponsored ad format – Short “warning” is fixed – can’t be modified – “More info” link will direct to risk information 29 29
  • HOMOCIDAL LUNATIC 30 30
  • 31 31
  • Guides Concerning the Use of Endorsements and Testimonials Concerns • Providing payment or other consideration for favorable posts – Free products are consideration • Key is disclosure of connections – Must disclose connections between advertisers and their endorsers that might materially affect the weight or credibility of the endorsement. • Creating clear policies are also key: – Policies should address disclosure • Requiring reviewers receiving cash or other compensation to disclose • If receiving free products, that should also be disclosed 32 32
  • Guides Concerning the Use of Endorsements and Testimonials FTC Example: • Company participates in a blog advertising service. • Company requests that a blogger try a new lotion and write a review of the product on her blog. • No specific claims about eczema, but blogger writes that the lotion cures eczema and recommends to her blog readers with eczema. • Company is subject to liability for false or unsubstantiated statements. • The blogger also is subject to liability. • The blogger also liable if she fails to disclose clearly and conspicuously that she is being paid. 33 33
  • Discussion and Q&A Larry Weber Joe Shields Chairman Product Director, Consumer Marketing Digital Influence Group and & Strategy Integration Racepoint Group Pfizer Michael Manthei Marc Reisler Partner Partner Holland & Knight Holland & Knight 34 34
  • Additional Resources • To get a copy of our white paper on “Navigating Regulatory Issues of Social Media in Healthcare” • Email: webinar@w2groupinc.com • Webinar recording • www.racepointgroup.com/digital/resources.cfm • www.digitalinfluencegroup.com • To continue the conversation, go to: • http://healthcareandthesocialweb.ning.com/ • Other questions, contact: • Jackie Lustig at jlustig@w2groupinc.com 35 35