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?

1. Its 2018…Should US Pharma
still be scared of Digital?
Gary Monk
March 5, 2018

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Don’t be scared, say hello!
@garymonk
linkedin.com/in/garywmonk/