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It's 2018, Should US Pharma still be Scared of Digital?


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Follow up analysis of the breaches to the US FDA OPDP regulations by Pharma, looking at the reasons why and digital channels employed. Do Pharma really have an issue using digital from a compliance perspective?

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It's 2018, Should US Pharma still be Scared of Digital?

  1. 1. Its 2018…Should US Pharma still be scared of Digital? Gary Monk March 5, 2018
  2. 2. Introduction • This is a follow up to my recent popular post about UK pharma, an analysis to see what the situation is on the other side of the pond • The biggest barrier to digital adoption in Pharma is ‘Regulatory, legal and health care compliance issues' • How grounded in reality is this fear? When Pharma 'do digital' do things go wrong? And if so why? • To answer the above for US Pharma I analyzed over 100 FDA, Office of Prescription Drug Promotion (OPDP) warning letters spanning the last 7 years, identifying the ‘guilty’ marketing channel (Via which misleading or a lack of fair & balanced information was disseminated)
  3. 3. 10 20 30 40 2011 2012 2013 2014 2015 2016 2017 31 28 24 9 9 11 5 In the last 7 years (2011 to 2017) The FDA issued 117 OPDP warning letters There has been a downward trend in warning letters issued Does this mean Pharma are becoming more compliant in all communications OR that the FDA are deploying less resources? Number of warning letters per year
  4. 4. Number of warning letters (2011-2017)23 11 80 In these 7 years 96 different Pharma companies received an FDA OPDP letter Does this mean Pharma take the FDA letter seriously and change behavior OR that the FDA is simply spread too thin? One Two Three Four Number of companies per number of letters The vast majority of companies had only one breach with a few ‘repeat offenders’, one company having four over the period
  5. 5. Non-Digital 61% Digital 39% Over the period 127 channels were implicated, 50 were digital (39%) Percentage of digital / non-digital channels implicated by FDA, OPDP letters
  6. 6. Non-Digital 95% Social Media 5% And of these 127 channels, only 6 related to social media (5%) Percentage of social media / non social-media channels implicated by FDA, OPDP letters • 4 were on You Tube, purely the video content and not any comments of social posts • 1 was on Facebook, related to content on the page description, not any posts by the company or users that could have been deemed misleading • Only 1 was related to social content of a dynamic nature, Instagram use by a celebrity endorser (The Kim Kardashian post)
  7. 7. 18% 35% 53% 70% 2011 2012 2013 2014 2015 2016 2017 26% 42% 36% 44% 56% 64% 43% The percentage of warning letters relating to digital channels appears to be increasing There is an upward trend in letters relating to digital suggesting Pharma are getting stuck in and making some mistakes along the way? A caveat is a potential lack of statistical significance, with the relatively low number of letters per year, e.g. only 5 in 2017 Number of warning letters per year related to digital channels 26% 42% 36% 44% 56% 64% 43%
  8. 8. Website 60% Social Media 12% Video Content 12% Email - HCP 6% Podcast 2% Online Brochure 2% 3rd Party Website 2% Search Ad 2% Banner Ad 2% But the majority of warning letters sent relate to websites suggesting a lack of innovation? But many US Pharma co’s are clearly working with social media, creating and managing their own Facebook pages and/or using paid posts, meaning: In these cases Pharma are either delivering these initiatives compliantly (as there are so few warnings) OR - The FDA have not been able to keep up with ‘policing’ these initiatives / their focus is on other ‘core’ channels Percentage of types of digital channels implicated by FDA, OPDP letters 2011-2017
  9. 9. NO 94% YES 6% And of these 50 digital channels, only 3 (5%) were possibly related to the complexity around digital Was the issue leading to the FDA letter ‘possibly’ related to digital complexity? The vast majority of issues related to digital channels were because of misleading content, e.g. on a webpage, where there were no issues related to space. The 3 breaches possibly related to space and the companies failing to incorporate drug safety / risk information were: • The Kim Kardashian Instagram / Twitter post • One example of a banner ad • One example of a search ad
  10. 10. The non-digital issues leading to warning letters all related to misleading content The fundamental issue Pharma face is ensuring they provide fair, balanced and accurate information. It has little if anything to do with digital vs non-digital or the type of channel employed The ‘top’ digital channels implicated in FDA OPDP warning letters (2011-2017) Rep Detail Print Mailing Exhibition Stand Leavepiece HCP Patient Brochure 0 4 8 12 16
  11. 11. So what is going on here? • Pharma are either mostly compliant in digital OR The FDA are under resourced / not focusing their resources on digital (based on the relatively low number of warning letters issued)
  12. 12. Looking at the FDA priorities their focus is more ‘traditional’ • The FDA’s core focus is not digital, for voluntary submission they require the following categories • ‘Comprehensive Labeling piece’ directed at professionals, e.g. detail aid or exhibition panel • An Advertisement to professionals, e.g. journal ad • One comprehensive DTC Labeling piece e.g. Patient brochure • One DTC advertisement e.g. Magazine Ad • A professional and/or DTC Website This would explain the FDA’s focus on these categories. Over 50% of the letters issued cover these above areas Of course websites are ‘digital’ but rarely complex or innovative
  13. 13. I asked the FDA for some feedback • I was told “The FDA does not provide comment on its internal processes or on external presentations and articles” • However they kindly provided additional background on the FDA’s oversight program, which actually gives a good perspective
 (The full communication is on the next two slides, I have simply taken the liberty to split into the digestible chunks)
  14. 14. Feedback from the FDA (1 of 2) • "Issuing warning letters is just one component of the FDA’s multi-faceted program for the oversight of industry’s promotion of FDA-regulated medical products. We have many efforts to encourage compliance by industry, including our work on Guidances, providing advice to companies on draft promotional materials, and outreach to our stakeholders” • "The FDA’s priorities regarding prescription drug promotion are; policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications, and enforcement” • "The FDA uses a risk-based approach to carefully allocate its resources among these activities to have the greatest beneficial public health impact. Therefore, one cannot get a complete picture of the FDA’s program area by looking at a snapshot of time for warning letters"
  15. 15. Feedback from the FDA (1 of 2) • "Reviewing the number of warning letters that the FDA issues on a particular topic within a year timeframe does not take into account the work that the FDA does on the other priorities to assist companies with compliance, such as policy and guidance development and core launch reviews, to fulfill its public health mission” • "To help increase voluntary compliance, the FDA continues to devote additional resources to its work on Guidances and providing advice to companies for draft promotional materials, where appropriate"
  16. 16. Summary • It is true this research is narrow, however it is focused on the area Pharma fear most, being found in breach of the FDA regulations, the enforcement piece • The FDA’s focus is broad and proactive, trying to prevent companies breaking the rules in the first place. This research supports that approach. I would not recommend that the FDA hire a bunch more people to focus on ‘digital compliance’ because… • Digital channels are not the problem, it is Pharma internal processes and culture that lead to the dissemination of misinformation, regardless of the medium used (exactly as in my recent UK analysis)
  17. 17. Don’t be scared, say hello! @garymonk