Fair Balance (FB) - PAAB Training Portal

• Provide PAAB code advice in response to
proposed campaign plans.
• Make rulings about whether specific activities
and/or messages are aligned with the code
(emphasis on digital).
• You’ll flex your evidence requirement muscles to
make rulings about whether presented
references are appropriate for the
proposed codes.
PAAB 401
Patrick Massad
Deputy Commissioner, PAAB
November 2014
Afternoon Main Topics
• Building compliant campaigns across both
digital and traditional media
• Ensuring there is a fair balance between risk
in benefits in advertising
• Submitting claims reflecting the evidence
standards in the PAAB code and guidances
Corrazon® (50mg Babugatran tablet)
• Rx anticoagulant
• Indicated for prevention of stroke in patients with
atrial fibrillation
• Key safety considerations: Bleeding and diarrhea
• 1 tablet BID regardless of kidney or liver status
• Don’t take within 1 hour of milk product
• Market leader (TRx data)
• Winner of MMEA for the Canadian television ad “Tu
ares mi Corrazon”
(i.e. Massad Marketing Excellence Award)
Gorilza® (100mg Babugatran)
• Pretty much Corrazon in a once daily pill
(thanks to our patented Chepeziac Controlled
Release Matrix®)
• It’s in the same PM as Corrazon but it has its
own pivotal trials and a separate Part III
• Canada is the first country in the world to
launch it
• Available since Nov 1, 2014.
Key Branding Images
Spokesperson for Corrazon
Exercise 1.
Conceptualize a website
Keep in mind that PAAB Pharma Inc wants a single website:
– For both products AND
– Disease info in two formats
• One written for the 6th grade level
• One written using language and content appropriate for clinicians
At least one person per table should neatly map out a highlevel description of the structure of your website.
i.e. create something like this…
• On a conceptual level, determine the site’s structure
– Map out where general types of information would go (e.g. “Corrazon
Claims”, “Disease info”, “Safety Info” for both products in all audiences).
• What is the landing page url?
• Identify outgoing links (e.g. corporate website)
• If applicable, where/which gating mechanisms will be employed
• Identify which segments will be coded with a “no index”
• Describe any links on your landing page. The manufacturer has a
lengthy legal page on the corporate website for privacy.
Don’t worry about SEO and SEM and incoming links yet. That will come
15 min
URL www.strokepreventionatpaabpharma.ca
No-index command
used on all pages
following a gating
Since homepage is
not branded, it can
link to corporate
site home page.
5 min
Exercise 1 part Deux
Where appropriate, include instructions related
to meta data.
5 min
Switching gears. For now…
Forget about the combined website.
For the website, www.corrazon.ca your boss wants you to get the
following SEM keywords approved by PAAB. Do you need to manage
her expectations for any of the following?
a. The word “Corrazon”
b. The word “Corrazone”
c. The word “Corrazoon”
d. The word “Pradaxi”
e. Study names (both pivotal and ongoing) e.g. Raj study.
f. The keyword phrase “side effects”
g. The word “Bleeding”
h. The word “Efficacy”
i. The Broad Match Key Word “Corrazon”
j. The keyword phrase “Two dogs rowing”
5 min
Let’s add UGC functionality to our combined
site. Is intervention necessary in the following
If so, how are you intervening?
a. Patient portal: “I took my Corrazon with me when I
visited the capital of Canada, Toronto”.
b. Patient portal: “I experienced severe skin
discoloration while on Corrazon” [There is no mention
of this effect in the product monograph]
c. Patient portal: “I take my tablet with a glass of milk. I
have not had diarrhea since starting this”.
d. Public section: “Corrazon sucks. My doctor put me on
it to prevent a stroke. Well, I’ll tell you one thing, it
succeeded in preventing me from having enough cash
to buy my Viagra.”
5 min
Which of these scenarios
require monitoring?
a. PAAB Pharma Inc purchases Corrazon Facebook banner
ads. Do the walls and timelines the ad appears next to
need to be monitored by PAAB Pharma Inc?
b. How about comments in an app description for PAAB
Pharma Inc’s unbranded app on A.Fib?
c. How about comments in response to a YouTube video for
the Corrazon TV commercial posted by
d. How about posts on a Corrazon FaceBook page created by
PAAB Pharma Inc?
e. The Taco Bell dog is a spokesperson for Corrazon. Might
PAAB Pharma Inc be responsible for tweets from his
personal Twitter account?
5 min
You’ll be doing internal training on PAAB
requirements for app descriptions accessible in
the apple store. Write down all elements the
PAAB will need to review and note one or two
important regulatory pointers to keep in mind
for each element.
5 min
What changes if the app is going to only be
available from the website we created?
Fair Balance
HCP rotating banner ad
1. Draw a single banner ad (with multiple frame) for both Gorilza
and Corrazon which highlights the following elements:
– Item 1. The statement “Corrazon is the # 1 dispensed anticoagulant by
cardiologists”[referenced appropriately to IMS Brogan Compuscript]
– Item 2. Two cartoon Rx Pads. One with the text “Corrazon 50mg BID”,
the other with the text “Gorilza 100mg OD”.
– Item 3. The PM statement “Not metabolized in kidney or in liver”
– Item 4. The statement “CCS recommends Babugatran as a first line
agent for prevention of stroke in atrial fibrillation patients”[reference
to the 2012 Canadian Cardiovascular Society guidelines]
– Item 5. The statement “Corrazon and Gorilza are indicated for the
prevention of stroke in patients with atrial fibrillation”
– Item 6. Designate an area on the banner which will contain the balance
level. What level of FB are you using? Where will the indication
Given only what you know for sure, is there a problem with one of the items.
5 min
Identify all ways you could meet
highest level FB requirements
Corrazon reprint holder
5 min
Identify all ways you could meet
highest level FB requirements
Gorilza Tent Card
5 min
What level of FB is required
based on visible content?
• A two sided card containing only information
describing the ongoing Raj study. Here is one
of the two sides:
RAJ Trial
Landmark Study In DVT Prevention
• Primary: Lorem ipsum dolor sit amet, consectetur
• Secondary: sed do eiusmod tempor incididunt ut
Start date: Feb 2012
End date: March 2015
Will be the largest
study in DVT
• By the way, do any issues jump out?
• Can we add this study to our website when published?
5 min
Recall this claim which PAAB
Pharma Inc wanted??
• “Gorilza is Corrazon in a once daily dosing
• “Gorilza offers the efficacy and safety of
Corrazon in a once daily dosing format”.
• “Gorilza demonstrated similar efficacy and
safety to Corrazon. Gorilza is dosed once
• Gorilza is babugatran in a once daily dose
Please approve this tiny unsolicited
change indicated by use of red font
Babugatran 5 years of use in Canada:
• 50,000 patient years of use
• Gorilza is babugatran in a once daily dose
Can we make the claim “Celebrex has a lower
incidence of abdominal pain vs Diclofenac”?
How about “Celebrex
has a 4.1% incidence
of abdominal pain vs
9% for Diclofenac”?
Exercise 2: See table 25
(ONLY table 25 for now)
You are the reviewer. PAAB Pharma submitted
the following presentation referenced to Table
25 of the Xarelto PM:
Total Stroke and Systemic Embolism:
Xarelto demonstrated reduction vs Warfarin
(1.7%/yr vs 2.15%/yr respectively, p=0.015)*
That’s only part of the piece, but it’s the entire segment relating
to table 25. Any changes required?
5 min
Exercise 2 continued: See table 4
(ONLY table 4 for now)
You are the reviewer. PAAB Pharma submitted the
following presentation referenced to Table 4 of the
Xarelto PM:
Demonstrated Efficacy:
• Lower rate of intracranial hemorrhage vs warfarin
(0.49%/yr vs 0.79%/yr, p=0.019)*
That’s only part of the piece, but it’s the entire
segment relating to table 4. Any changes required?
5 min
Say table 4 was based on an interim analysis and
updated data is now available. When can the
APS be revised to include the updated data?
Exercise 2 continued: See table 2
(ONLY table 2 for now)
You are the reviewer. PAAB Pharma submitted the
following presentation referenced to Table 2 of the
Pradaxa (dabigatran) PM:
Safety Profile:
• Similar incidence of adverse events vs warfarin
(72.0% vs 70.8% p=NS)*
That’s only part of the piece, but it’s the entire
segment relating to table 2. Any changes required?
5 min
eDetailing: Clicking on an icon
next to the claim reveals…
Scenario 1
Scenario 2
Linkage assessed
Reviewed as
though it were
APS copy
Hypothetical Survey Question
“Imagine that there was a Corrazon patch on the market that
was as at least as effective but safer than warfarin, Pradaxi, and
Eliquist. Would you like to try that patch?”
A. Fib Patients
“If your anticoagulant therapy entailed replacing a patch once
per week, how likely are you to adhere to your anticoagulant
therapy?” 70%
Not likely
Somewhat likely
Very likely
Global Creative:
With Gorilza, stroke prevention
takes less than 10 seconds per day
Once daily dosing