Social Media in the pharmaceutical and medical device industries pre FDA rules
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Social Media in the pharmaceutical and medical device industries pre FDA rules

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Whats next for the pharmaceutical and medical device industries; waiting on the FDA? PRSA webinar

Whats next for the pharmaceutical and medical device industries; waiting on the FDA? PRSA webinar

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  • It is important for the health care industry to begin 2010 with a clear vision for embracing social media. In 2009, health care regulators finally started to address the issue - from the FDA's public hearings to the creation of a digital marketing working group by the UK's Pharmaceutical Marketing Society. There is no denying that consumers are constantly turning to the Internet as a source for health information. As communications professionals, we need to understand the opportunities, challenges and threats of the emerging digital world.
  • The second edition of the Guide includes updated PhRMA and EMEA codes, expanded country coverage and features a foreword by Louis Morris Ph.D., Former Acting Director, Division of Drug Marketing, Advertising and Communication at the FDA. The Guide provides an overview of basic healthcare promotional in an easy to follow frequently asked questions format.
  • Consumption of media by media type. Digital isn’t the wave of the future – it’s the tool of now . In order to be a dominant market player in science and technology, companies need to be leaders in the medical industry's digital push and not playing catch-up with competitors.
  • Young people represents 18-29
  • Connect with 2/3 of your audience through their preferred method of communication Nike drops traditional marketing budget in favor of digital video, Pepsi switches 20m from Superbowl to digital.
  • digital sphere (blogs, forums, message boards, Twitter, etc.). and (when appropriate) engage with them to promote your brand. Social media presents an opportunity for companies to represent themselves as real people and not massive fortresses immune to open dialogue.
  • In this message, a caregiver whose mother was receiving chemotherapy reported that her mother experienced abdominal fluid retention, noted that this was not a listed side effect of the medication, and inquired in the online community whether this fluid retention might be a sign that the medication was working.
  • If we multiply the total number of posts per day by the number of posts that contain adverse events that are both serious/life-threatening AND unexpected and have the other three criteria required for an adverse event  = adverse events generated per day that need to be reported in 15 days to the FDA. This means that the entire pharma industry (assuming the FDA holds them responsible for every online discussion) would have to manage only 166 reportable adverse events per day. Divide this number among all of the pharma companies and that is a completely manageable amount of work under the industry’s already robust AE monitoring efforts. It’s important to remember that pharma companies are not required to monitor everything out there and you only have to report events that are reported to you (which would include posts or comments on Web sites you oversee/control) or events that you come across elsewhere online. Knowing all of this, as an industry, should we have to curtail social media usage because of only 166 reportable events a day? NO!
  • This means that the entire pharma industry (assuming the FDA holds them responsible for every online discussion) would have to manage only 166 reportable adverse events per day. Divide this number among all of the pharma companies and that is a completely manageable amount of work under the industry’s already robust AE monitoring efforts. (which would include posts or comments on Web sites you oversee/control)
  • FDA guidelines are coming, we just don’t know when. When the FDA releases guidelines, though, it is unlikely that they will be clear-cut. They will most likely be a broad set of rules which will be open for interpretation.
  • Here is an overview of a recent company we were hired to work with – Company A – and a look at their direct competitors and where they have a digital presence.
  • The opportunity exists now for pharma and medical companies who can successfully navigate the social media waters to emerge as a leader and innovator in communicating with patients in the digital space.

Social Media in the pharmaceutical and medical device industries pre FDA rules Social Media in the pharmaceutical and medical device industries pre FDA rules Presentation Transcript

  • Social Media and Health Care: A Global Perspective: How to Leverage Social Media in a Regulated Industry January 27, 2010 3 p.m. EST
    • Today’s panel:
      • John Seng , President and CEO of Spectrum , one of the top independent health care-only public relations firms in the U.S. Seng is also co-founder and chair of GLOBALHealthPR
      • Neil Crump , Co-Founder and Managing Director of Aurora, one of the premiere independent communication firms in the U.K. focusing exclusively on health care. Crump is also a partner in GLOBALHealthPR
      • Kevin Walsh , Vice President of Digital Strategy at Spectrum, one of the top independent health care-only public relations firms in the U.S.
    • What we’ll cover:
      • The importance of digital media.
      • What challenges medical companies face in the global digital landscape.
      • What opportunities arise as a result of digital media.
    Introduction
    • GLOBALHealthPR is the largest independent public relations group dedicated exclusively to health and medical communications worldwide.
    • GLOBALHealthPR implements national, regional and global objective-led campaigns that are culturally relevant and will work in the US, and major European, Latin American and Asian markets.
    • GLOBALHealthPR's Global Guide to Pharma Marketing Codes is designed to help pharmaceutical marketers and public relations specialists more effectively design global campaigns by serving as a simple resource to help navigate health care marketing and promotion regulations around the world.
    GLOBALHealthPR
    • Only two countries in the world allow promotional communication about prescription medicines to consumers (U.S. and N.Z.).
    • Digital media has global reach www.drugbrandname.com can be assessed by non-US citizens.
    • In MOST countries outside the U.S., disease awareness campaigns (that do not create demand for a specific treatment) are allowed.
    • Digital media can be employed in MOST countries (although wide difference in local regulations).
    • Careful in the use of language:
      • Digital Media: All encompassing. One-way online/Internet-based communication channels.
      • Social Media (Web 2.0): Interactive, o nline activity where genuine two-way communication takes place between a client and their audiences.
    The Global Digital Paradigm
  • Why Digital Matters Data provided by The Pew Research Center for the People and the Press
  • Why Digital Matters Data provided by The Pew Research Center for the People and the Press
    • Find and Reach motivated audiences
    • Build Brand Ambassadors
    • Increase ROI
    What Are Your Objectives in Using Digital Media?
  • How Can You Reach These Objectives with Digital Media? Listening Actively listen to your brand, your competition and your industry in the digital sphere. Identify the top influencers for your brand, your competition and your industry and engage with them. B rand . Engagement Transparency
      • Build authentic and transparent relationships with your audiences and influencers.
    • There are three main obstacles to consider with social media:
      • Regulation
      • Competition
      • Reputation
    What are the Challenges in the Digital Landscape in the U.S.?
    • During November’s FDA hearing on the use of social media, it became clear that pharmaceutical and medical device industries would like to see clear guidance from the FDA on their responsibilities in the social media space. In particular for adverse event reporting (AER) as this is a major issue that both pharma companies and the FDA is grappling with.
    • An adverse event (AE) is a harmful and undesired effect resulting from a medication or other intervention such as surgery.
    • What do you need to have a “reportable adverse event”?
      • Identifiable patient
      • Identifiable reporter
      • Specific drug or biologic involved in the event
      • Adverse event or fatal outcome
      • *If you don’t have all four, the FDA won’t accept an AE report.
    Regulatory Challenges
    • In 2008, Nielsen randomly selected 500 healthcare-related messages posted online across multiple disease categories from the massive amount of content they monitor daily.
    • They then analyzed these messages to see if any met the requirements for a “reportable adverse event.”
    • Out of the 500 messages , Nielsen found only one message that incorporated the information needed to meet all four of the FDA’s AE reporting requirements.
    • One message out of 500 translates to .002%. The probability of your house being struck by lightening is higher (.005%).
    Adverse Event Reporting and Social Media
    • Nielsen regularly scans more than 100 million sites. Around 1,350 of these are healthcare-specific and have some discussion component to them (forums, blogs, Q&A, etc.). These 1,350 sites generate almost 83,000 new posts every day. While this might seem overwhelming at first – it’s not…
    Adverse Event Reporting and Social Media
    • It’s important to remember that pharma companies are not required to monitor everything out there and you only have to report events that are reported to you, controlled by you or events that you come across elsewhere online.
    • To put the numbers in perspective:
    • 12,777 pharmaceutical companies in the US (www.Manta.com)
    • need to monitor 166 AEs.
    • Should this be a reason to curtail social media usage?
    Adverse Event Reporting and Social Media
    • Regardless of attendance at the public hearing, interested parties can submit written or electronic comments to the FDA until February 28, 2010.
    What Happens Next?
  • Competition Challenges The first step in any campaign is a digital audit. This will help you understand the role you and your competitors play in the digital arena. Today with a fixed number of potential clients your competition is only going to increase with time and two or three years down the road, you’ll wish you had as “easy” competition as you do now. Company A ($10.5 billion in ‘08 sales, 34,500 employees) Corporate     X   X HR             Brand X X     X X X Company B ($5.8 billion in ‘08 sales, 18,000 employees) Corporate X   X X   X HR X  X X       Brand   X X X   X     X Company C ($1.6 billion in ‘08 sales, 9,700 employees) Corporate X X X X   X HR   X       X Brand X    X X X      X Company D ($7 billion in ‘08 sales, 28,000 employees) Corporate X  X   X     HR             Brand            
    • Within social media, there is now an ongoing conversation about your brand, competition or industry. That conversation will continue to happen, regardless of your participation.
    • By engaging in the online conversation, you have the opportunity to identify these negative conversations and be in a position to quickly spot any potential issues.
    Brand Reputation
    • To recap:
      • In MOST countries outside the U.S., disease awareness campaigns (that do not create demand for a specific treatment) are allowed.
      • Digital media can be employed in MOST countries (although wide difference in local regulations).
    • Regulations specific for the use of digital media do not really exist in MOST markets.
    • Regulations specific for the use of social media do not exist.
    • Innovative companies are using digital media using the principles of traditional channels and in MOST cases this is NOT causing any problems.
    Digital Media Use Outside the U.S.
  • Use of Digital Media Webcasting Carer Websites Disease Awareness Other Applications…
  • Use of Social Media YouTube Campaigns Twitter
    • Instead of waiting a year or longer for the FDA’s guidelines, develop social media policies now. As a first step, companies should produce and enforce social media guidelines.
    • Pharma should be listening. There is a goldmine of knowledge on the web. Given the likelihood that finding an AE online has such a low probability, listening becomes even more important. (Ensure your monitoring teams are drug safety trained!)
    • Become comfortable with digital tactics by using social media to promote corporate communications, investor relations, HR/employment, etc.
    • Remember – it’s important to integrate digital/social media tactics into your already established communications methods, rather than keeping them separate.
    What You Can Do Now?
    • Spectrum: www.spectrumscience.com
    • Aurora: www.auroracomms.com
    • GLOBALHealthPR: www.globalhealthpr.com
    • FDA: www.fda.gov
    Resources
  • Questions?
  • Thank You