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Whats next for the pharmaceutical and medical device industries; waiting on the FDA? PRSA webinar
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Social Media and Health Care: A Global Perspective: How to Leverage Social Media in a Regulated IndustryJanuary 27, 20103 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, online 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
1. Find and Reach motivated audiences
2. Build Brand Ambassadors
3. 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. Brand.
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
Company A ($10.5 billion in ‘08 sales, 34,500 employees)
Corporate X X
HR
Brand X X X X XCompany B ($5.8 billion in ‘08 sales, 18,000 employees)
Corporate X X X X
HR X X X
Brand X X X X XCompany C ($1.6 billion in ‘08 sales, 9,700 employees)
Corporate X X X X X
HR X X
Brand X X X X XCompany D ($7 billion in ‘08 sales, 28,000 employees)
Corporate X X X
HR
Brand
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.
• 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 MediaWebcasting
Carer Websites
Disease Awareness
Other Applications…
Use of Social Media
YouTube Campaigns
• 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