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FDA Social Media

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"Uncertainty can be a Guiding Light" ...

"Uncertainty can be a Guiding Light"

To truly leverage the power of social networks, Pharma need to understand the principle of open innovation and learn to live with (and take) communication risk.

The FDA will never give crystal clear guidelines on social media. Their existing statements is all the real direction any compnay needs

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  • Good Afternoon. My name is Brad McCormick I am the Global Digital Director at Porter Novelli. Unfortunately Peter Pitts, our Global Director of Regulatory as Porter Novell (as well as a former FDA Commission could not be here today). He is attending to a client matter in Moscow But I am very happy to be here in his place and hope that I will make for a suitable replacement.
  • The title of my presentation is “Pharma, The FDA, and Social Media”—uncertainity can be a guidling light.That phrase—”Uncertainity can a be guiding light” actually comes for a much overlooked u2 album—I am a big U2 fan—call Zooropa. The album was written about the confusion in Europe after the fall of the berlin wall, where the old ways no longer worked and everything seems new and confusing. In many ways, I think pharma marketing is in similar light of uncertainity and I hope to explain today why I think if pharma really wants to leverage digital and pharma uncertainity is something that must be embraced
  • I also want to point out that I know how serious this stuff is. This is a picture of my cousin Robert Ruffino and his family. About 8 years ago, Robert was diagnosed with Chronic Mylod Leukemia or CML. Had he been diagnosed a few years earlier ,he probably would not have survived.
  • Fact #1 – The world is getting older, faster 69,0000Pew Research recently released a study stating that starting in 2011, 10000 Americans will reach retirement age everyday for the next 19 years. These are individual whose health and life expectancy will depend in part on the products that phamaceturial industry manufacturer
  • In Pharma DTC advertising used to be safe bet. That is, a pharma market knew if he or she spent x amount of dollar on a DTC, they could expect Y among of people to visit their doctor. I have heard anywhere from 25 to 60% of those visits results in a new diagnoses and a new prescription.But like with every other industry, those traditional market9ing are proving less effective. People don’t watch TV the way their used to, nor do they consumer print they way they used to. Many don’t ever consumer print.Just as there are fewer and few block buster drugs in the pipeline, there are fewer blockbuster marketing budgets. As such, Pharma needs to find new way to reach its audience, raise awareness and get people into their doctors office.
  • More people now visit facebook than google. Social Networking—2 way conversations—is becoming the domoninant dynamic online.
  • You might have seen this op-ed that ran in the Boston Globe back in Jan. In it, two researchers are
  • Imagine buying an HD TV but only showing Black & White programs on it.
  • Pfizer recently launched a Youtube channel where they actual solicit adverse events from their consumer
  • R
  • Right now only four countries allow any form of DTC pharma advertising: the US, New Zeland, Banglesh, and South Korea.I think both because tightening budgets and how I think pharma is going ultimately embrace social media you will see a risining of marketing activity that benitis both DTC countries and countries, like cananda, that do not.
  • The reasons are two fold:1) One while I have tried to make the case that it is permissible for pharma to engage in social media dialogue about its products the truth of the matter is that very few pharma companies are likely to embrace branded social media dialogue full force. Therefore the most “explicit” use of pharma social media will be via non-branded corporate communications that benefits nearly every locale. All of the examples I have show by the way are corp com. Rise of “Branded Generics”…would you rather purchase a generic from Company X or from Johnson & Johnson?Rise of Generics in emerging markets for price sensitivityWill help in talent recruitment
  • Brand as publisher-You will see more non-branded educational content created on the web with higher production values2 fold:To combat misinformationSearch engine optimizationAnd continue to establish trust between a corp manufacturer and patient.
  • Brand as publisher-You will see more non-branded educational content created on the web with higher production values2 fold:To combat misinformationSearch engine optimizationAnd continue to establish trust between a corp manufacturer and patient.
  • The cumulative effect of patients failing to adhere to their treatment regimens is costing the pharmaceutical industry in excess of $30 billion a year
  • Right now only four countries allow any form of DTC pharma advertising: the US, New Zeland, Banglesh, and South Korea.I think both because tightening budgets and how I think pharma is going ultimately embrace social media you will see a risining of marketing activity that benitis both DTC countries and countries, like cananda, that do not.
  • The title of my presentation is “Pharma, The FDA, and Social Media”—uncertainity can be a guidling light.That phrase—”Uncertainity can a be guiding light” actually comes for a much overlooked u2 album—I am a big U2 fan—call Zooropa. The album was written about the confusion in Europe after the fall of the berlin wall, where the old ways no longer worked and everything seems new and confusing. In many ways, I think pharma marketing is in similar light of uncertainity and I hope to explain today why I think if pharma really wants to leverage digital and pharma uncertainity is something that must be embraced
  • I also want to point out that I know how serious this stuff is. This is a picture of my cousin Robert Ruffino and his family. About 8 years ago, Robert was diagnosed with Chronic Mylod Leukemia or CML. Had he been diagnosed a few years earlier ,he probably would not have survived.
  • Good Afternoon. My name is Brad McCormick I am the Global Digital Director at Porter Novelli. Unfortunately Peter Pitts, our Global Director of Regulatory as Porter Novell (as well as a former FDA Commission could not be here today). He is attending to a client matter in Moscow But I am very happy to be here in his place and hope that I will make for a suitable replacement.
  • I also want to point out that I know how serious this stuff is. This is a picture of my cousin Robert Ruffino and his family. About 8 years ago, Robert was diagnosed with Chronic Mylod Leukemia or CML. Had he been diagnosed a few years earlier ,he probably would not have survived.

FDA Social Media FDA Social Media Presentation Transcript

  • PHARMA, THE FDA & SOCIAL MEDIA: Uncertainty Can Be A Guiding Light
  • “Uncertainty Can Be A Guiding Light” -U2, Zooropa 1993
  • White Blood Cell Count: 50,000
  • What I Will Address• What the FDA has said, will likely say, and is not going to say.• The business case for embracing uncertainty• 6 Misconceptions for social media• What this means for Canadian Pharma and Pharma overall• Q&A
  • First, 3 Facts:
  • Fact #1: The World is Getting Older, Faster10k x 365 x 19 years
  • Fact #2:Traditional DTC MarketingModels are losingeffectiveness
  • Fact #3:The FDA has yet to issue anythingsince Part 15 hearings.
  • FDA: what they have said, are going tosay, and are not going to say
  • FDA: What They Have Already Said.
  • What They FDA Has Said “Follow the regulations” Advise given by Tom Abrams, the head of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), regarding Pharma & Social Media Feb 2011
  • What the FDA HasSaid: 1. Adverse Event information must be included in all DTC advertising materials. 2. Reports of Adverse Events must be reported if they meet 4 basic criteria. 3. Companies are required to ensure that adverse information is listed and is accurate on any site that is sponsoredby the product manfactuer.
  • 52 WarningLetters in 2010.
  • SOURCE: Eye on FDA: http://www.eyeonfda.com/eye_on_fda/2011/01/ddmac-warning-and-nov-letters-lookback-for-2010.html
  • SOURCE: Eye on FDA: http://www.eyeonfda.com/eye_on_fda/2011/01/ddmac-warning-and-nov-letters-lookback-for-2010.html
  • Only Social Media Violation in 2010: EstablishedRule
  • FDA: What TheyAre (Most Likely) Going to Say.
  • Low Hanging Fruit •What Constitutes a “Sponsored” site? •Safe Harbor for correct information (i.e. Wikipedia) • Safe Harbor for Adverse Events (does not have to monitor every single site) • Possible clarity on “One Click” Rule
  • FDA: What TheyAre Not Going to Say
  • Do Not Expect 100% Clarity The FDA will not "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter …” Tom Abrams, the Head of FDAs Division of Drug Marketing, Advertising, and Communications (DDMAC) , Feb 2011
  • Do Not Expect 100% Clarity “…DDMAC is unlikely to create a major new standard for social media…” John Kamp Director,Coalition for Healthcare Communication
  • Do Not Expect 100% Clarity “…It’s impossible to impossible? expect the FDA to offer direct guidance [on Pharma & Social Media]” Peter Pitts Director of Global Regulatory, Porter Novelli Former Deputy Commission, FDA
  • Do Not Expect 100% Clarity “The real question is whether Pharma has the will to engage, because they certainty have the ability if they choose to use it.” Peter Pitts Director of Global Regulatory, Porter Novelli Former Deputy Commission, FDA
  • The Pharma Business Case forEmbracing Uncertainty
  • “In the age of Facebook and Google, itseems there should be a better, moresystematic way of harnessing thiscommunal wisdom and cultivating thissort of medical discovery. Enter openinnovation.”
  • Past: Closed Innovation Future: Open Innovation
  • Chess: •Clear, specific, unchanging rules •Finite set of pieces •Finite Set of moves •Clear how investment can lead to victory •Largest dynamic is intellectual •No ambiguity
  • Poker: •Few basic rules, but they can be modified •Finite set of pieces, infinite set of moves •Unclear how investment will lead to victory •Largest dynamic is social, emotional •Lots of Ambiguity. Lots of Risk.
  • Past: Closed Innovation Future: Open Innovation
  • Misconceptions about theFDA & Social Media
  • Misconception #1 Social Media = Digital Advertising /
  • Misconception #2 Social Media Content =Social Media Platform / X X X X
  • Misconception #3Having a Presence in Social Media = Being Social /
  • Dialogue is at the heart of social media
  • Misconception #4 All Adverse Events Must Be Reported
  • FDA Criteria for AE Reporting 1.An identifiable patient. 2.An identifiable person reporting the event. 3.A suspect drug or biological product. 4.An adverse experience or fatal outcome suspected to be due to the suspect drug or biologic.
  • 2008 Study:Listening to Consumer in a highly regulated environment 5 500: 1 Among 500 messages analyzed, one message incorporated all four AE reporting criteria
  • # reported = 0
  • Misconception #6 The FDA is going to provide clear guidelines for every possible aspect of social media.
  • 3 Future Trends and What This meansfor Canada Pharma
  • Trend #1:Non-branded Corporate Communicationswill become the most dominant form ofPharma Social Media
  • Trend #2: Brand as publisher. BeyondCSR content shift toward non –brandededucation content
  • Trend #3:The New DTC = Direct to Customer
  • DTC: Direct to Customer •Cost of patient non-compliance = $30 Billion •Companies will focus on adherence as much as acquisition • High produced educational videos vs. hard to read drug information text • Both public facing videos (disease content) and password protected (product direct content) video. May not be consider DTC. • Same energy and production values in pre-purchase should be applied to post purchase
  • • Focus on Global Corporation Communications• Brand as publisher: Educational non-branded content• The New DTC = Direct to Customer
  • Thank You
  • Brad B McCormickGlobal Digital DirectorPorter NovelliBrad.mccormick@porternovelli.com646 662 6297@darbtx