Lets get digital. Digital. I wanna get digital. (Playfully
adapted from Olivia Newton-Johns song) Exploring how the
advertising regulations apply to digital media such as websites,
banners, SEO, SEM, social media and apps. (s.6.5)
Slide 2
Menu du Jour Key considerations: Access, Content, Linkage and
Fair balance Exploring these across an array of digital tools
Websites Banner Ads SEO/SEM Social Media Apps
Slide 3
Critical Considerations for any e-media type i) The intent of
the message: Is the intent of the message to promote a drug,
disease awareness or a company? ii) The target audience solicited:
Is the information targeted towards healthcare professionals,
patients or the consumer? iii) The type of drug product: Does the
information pertain to a prescription, non-prescription, vaccine or
natural health product? iv) The nature of the online content: Does
the site allow for dynamic content or is it static (i.e. entirely
controlled by the sponsor)?
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WEBSITES (S.6.5.8)
Slide 5
Website (s.6.5.2) The name of the pharmaceutical company
sponsor should be stated clearly on: i)Every page of the web-site
controlled by the sponsor ii)On every sponsored web-page of a site
with no access control Except where regulatory requirements or
third party owners prohibit use of the company name.
Slide 6
Website (s.6.5.8) Websites are a complex medium for
communicating. They can be highly connected and accessible.
Determine who your audience will be from the onset HCP; Patient;
Consumer (DTC) Then Consider: Access control Content Balancing copy
Linkages
Slide 7
Website: ACCESS CONTROL ( s.6.5.6 ) It is the sponsors
responsibility to ensure that there is an acceptable barrier
between the information you produce and the various audiences
Acceptable barriers: Password required for entry (controlled
distribution) DIN (for patients ONLY) Professional License #
Arbitrary set of characters selected by manufacturer URL of a
website which is not indexed keys which bypass the barrier
(controlled distribution) CD, webkey, email Access through
moderator approval (with verification on the front end) Remember:
Landing page is accessible by the consumer
Slide 8
Unacceptable barriers Registration and/or attestation alone are
NOT sufficient barriers Website: ACCESS CONTROL ( s.6.5.6 )
Slide 9
All the current rules and regulations that exist for drug
advertising and other activities apply equally to online content.
Websites tend to house large amounts of content Websites are not
typically read in their entirety within a single sitting Difficult
to predict the path users will take through the site. Therefore:
Support needs to be presented with claims Website: CONTENT (
s.6.5.8 )
Slide 10
OVERVIEW: Jensulin vs. Passad demonstrated: Significant
reduction in A1C Similar decrease in FPG and PPG Reduced incidence
of nocturnal hypoglycemia
Slide 11
HCP website: Indication & fair balance on the home page
(post gate) or Beginning of each section containing product claims
AND A prominent Safety Information menu item visible from any
screen on the site Website: BALANCING COPY ( s.6.5.8, 2.4 )
Slide 12
Slide 13
About Jensulin Patient Profiles Diving into the Evidence
Jensulin Injections Safety Information Frequently Asked Question
Guideline Recommendations Get a Device www.Jensulin.ca/12390
Patient Counselling Resources
Slide 14
Website: BALANCING COPY
Slide 15
Principles: If you join advertising and non-advertising,
everything becomes advertising Branded and unbranded disease info
Product ad and editorial ad Internet links Product Package shot
Consider: Proximity Appearance Sequence Context The sponsor may
link to corporate global sites only by linking to the global site
home page. The sponsor should not link to the global site product
pages/sections. Website: LINKAGE ( s.6.5.4 )
Slide 16
BANNER ADS (S.6.5.5)
Slide 17
Banner Ads (s.6.5.5) Consumer banner ads Only banner ads that
meet consumer advertising requirements can be used on consumer
accessible sites Facebook Twitter Instagram etc. Audience, access,
content, and linkage are all still considered
Banner Ad (s.6.5.5) HCP gated banner ads: Those containing
either direct or implied product claims must: include risk/benefit
fair balance Consider GIF functionality to help address space
restrictions relating to fair balance. be page-linked to the
product monograph.
Slide 20
Frame 1 Frame 2 Frame 3 Pfizer Banner Ad: HCP
Slide 21
Secondary outcomes: Demonstrated significant reduction in
weight vs insulin passad -3.7lbs vs. insulin passad (p=0.001) 1
Demonstrated a low incidence of hypoglycemia The number of events
with Jensulin vs insulin passad: 18 vs 42; p=0.021 1 -1.4% mean
reduction (7.9% to 6.5%) from baseline vs -0.9% mean reduction
(7.9% to 7.0%) from baseline with insulin passad 1 Demonstrated:
Significant reduction in A1C vs insulin passad (p=0.01) Indication
and clinical use Jensulin is indicated for the treatment of Type 1
or Type 2 diabetes in patients over 17 years of age who require
basal insulin for the control of hyperglycemia Click here to learn
more Once daily sublingual basal insulin Indication with first
promotional claim?
Slide 22
Click here for important safety information about: The most
serious warnings and precautions regarding hypoglycemia and
administration Other relevant warnings and precautions regarding
allergic reactions, lipodystrophy, rash, antibody formation,
hypokalemia, sodium retention and edema Conditions of clinical use,
adverse reactions, drug interactions and dosing instructions The
product monograph is available at www.PAABPharma.ca\JensulinPM It
is also available through our medical department. Call us at
1.888.357.3243www.PAABPharma.ca\JensulinPM Highest level fair
balance? PAABPharma
Slide 23
Secondary outcomes: Demonstrated significant reduction in
weight vs insulin passad -3.7lbs vs. insulin passad (p=0.001) 1
Demonstrated a low incidence of hypoglycemia The number of events
with Jensulin vs insulin passad: 18 vs 42; p=0.021 1 -1.4% mean
reduction (7.9% to 6.5%) from baseline vs -0.9% mean reduction
(7.9% to 7.0%) from baseline with insulin passad 1 Demonstrated:
Significant reduction in A1C vs insulin passad (p=0.01) Indication
and clinical use Jensulin is indicated for the treatment of Type 1
or Type 2 diabetes in patients over 17 years of age who require
basal insulin for the control of hyperglycemia Once daily
sublingual basal insulin PAABPharma Indication upfront Rotating
banners
Slide 24
Presenting highest level fair balance within the rotating
banner ad Indication and clinical use Jensulin is indicated for the
treatment of Type 1 or Type 2 diabetes in patients over 17 years of
age who require basal insulin for the control of hyperglycemia Most
serious warnings and precautions Hypoglycemia is the most common
adverse effect of insulin Glucose monitoring is recommended Changes
to insulin should be made cautiously, under medical supervision
Administration Not intended for intravenous or intramuscular
administration Do not mix with any other insulin Don no use if not
water-clear and colour Other relevant warnings and precautions Risk
of allergic reactions, injection site reactions, lipodystrophy,
rash and antibody formation Hypokalemia Sodium retention and edema
For more information Please consult the Product Monograph at
http://PAABPharma/JensulinPM.ca for important information relating
to adverse reactions, drug interactions and dosing information
which have not been discussed in this piece. The Product Monograph
may also be obtained by calling 1.888.357.3243 Option 1: Highest
Level Fair Balance PAABPharma
Slide 25
Indication and clinical use Jensulin is indicated for the
treatment of Type 1 or Type 2 diabetes in patients over 17 years of
age who require basal insulin for the control of hyperglycemia Most
serious warnings and precautions Hypoglycemia is the most common
adverse effect of insulin Glucose monitoring is recommended Changes
to insulin should be made cautiously, under medical supervision
Administration Not intended for intravenous or intramuscular
administration Do not mix with any other insulin Don no use if not
water-clear and colour Other relevant warnings and precautions Risk
of allergic reactions, injection site reactions, lipodystrophy,
rash and antibody formation Hypokalemia Sodium retention and edema
For more information Please consult the Product Monograph at
http://PAABPharma.ca\Jensulin for important information relating to
adverse reactions, drug interactions and dosing information which
have not been discussed in this piece. The Product Monograph may
also be obtained by calling 1.888.357.3243 Highest level fair
balance Link to TMA directly Option 2: Middle linking to highest
level fair balance PAABPharma
Slide 26
Option 3: Middle linking to highest level fair balance on link
destination Indication and clinical use Jensulin is indicated for
the treatment of Type 1 or Type 2 diabetes in patients over 17
years of age who require basal insulin for the control of
hyperglycemia Most serious warnings and precautions Hypoglycemia is
the most common adverse effect of insulin Glucose monitoring is
recommended Highest level fair balance Note: This site now requires
review PAABPharma
Slide 27
Frame 1 Frame 2 Clicking takes you to www.celebrex.ca Pfizer
Banner Ad: HCP LINKAGE (s.6.5.4)
Slide 28
www.celebrex.ca
Slide 29
Banner Ad: LINKAGE (s.6.5.4) Frame 1 Pr
Slide 30
Frame 2 Pr Banner Ad: HCP
Slide 31
Frame 3 Pr Czech Tec Banner Ad: HCP for additional safety
information and a link to the product monograph for
information
Slide 32
Banner Ad: HCP Acceptable to link to brand website
Efficacy/safety claim in the ad, therefore link must lead to
highest level fair balance. Should not require additional effort
(i.e. take beyond gate
SEO/ SEM (s.6.5.10, 6.5.11) Search Engine Optimization
(s.6.5.10) Meta data text provided by the manufacturer (or its
agent) to a search engine for PAAB approved website: Must not
exceed consumer advertising regulations. Must not refer to
competitor products
Slide 37
SEO/ SEM (s.6.5.10, 6.5.11) Search Engine Marketing (s.6.5.11)
Composite of the user generated keyword, the metadescriptor, the
landing page, and the Uniform Resource Locator (URL) must not
exceed consumer advertising regulations. Must not purchase a
competitors product as a keyword Non-Rx sponsored search ads
containing claims must include Fair Balance.
Slide 38
DYNAMIC CONTENT (S.6.5.9)
Slide 39
Social Media (s.6.5.9) Websites and applications that enable
the user to create or share content or to participate in social
networking It allows for user generated content (UGC) or dynamic
content Content within areas that are under the sponsors control
are subject to all the current rules and regulations for drug
advertising and other activities
Slide 40
The sponsor of a site with UGC functionality looses some
control over the message BUT retains much of the regulatory risk.
Therefore Social Media (s.6.5.9)
Slide 41
Start by asking yourself some questions to align the site with
your risk tolerance How much control am I giving to the audience?
Will I have site rules? What will they be? How will I communicate
them? To what extent will the site be moderated? To what extent
will I be monitoring? What will I be looking for? Social Media
(s.6.5.9)
Slide 42
User Generated Content Can render a compliant page
non-compliant Terms and Conditions Clear and accessible e.g. clear
statement about what type of comments will be removed or modified
May minimize frequency of misuse Monitoring the Conversation i.e.
semantic, automatic filtering mechanism (brand key words, side
effects etc.) Social Media (s.6.5.9)
Slide 43
Correcting misinformation: e.g. misinformation about company or
disease Corrections must be made promptly. PAAB preclearance not
required if limited precisely to the minimum needed to correct
misinformation. Off-label discussions: Remove outright!! Adverse
event monitoring: Not enough to only provide a statement referring
reporters to the pharmacovigilance / medical department. Monitoring
the Conversations :
Slide 44
Chat room on your patient website for Asclepius A patient posts
that he has taken twice the recommended maximum dose to accelerate
his weight loss and has observed significant positive results. What
are your responsibilities? a.Remove the post as it encourages
off-label use of the product b.Keep the post but insert a
corrective statement (e.g., always follow the instructions of your
doctor...) c.You are not obliged to act as this was an unsolicited
comment that did not come from the sponsor and is not considered
advertising d.Provide the information to your med/reg dept. to
initiate a change in the labelling
Slide 45
Manufacturer should screen websites under its management or
responsibility for potential case reports Not expected to screen
external websites. BUT if it becomes aware of an AR on a website
that it does not manage, the manufacturer should review the case
and determine whether it should be reported. Implications on
listening activities A reportable adverse reaction must have
identifiable: i. Reporter ii. Patient iii. Drug iv. Event Ask
yourself whether a reasonable person taking reasonable steps can
determine these elements. Health Canada guidance document on
reporting adverse reactions
Slide 46
Responding to individual users questions PAAB review required
for sponsor/agent generated answers openly visible to entire
community One-on-one correspondence exempt from PAAB review
Slide 47
APPS (S.6.5.9)
Slide 48
Apps Content/Linkage Same restrictions as all other advertising
pieces Fair Balance Follow requirements based on positioning of
claims Assess in the same manner for which you would assess a
website Access Consider app store and gating once downloaded
Slide 49
App Store The combined content viewable prior to successful
password entry must not exceed the consumer regulations. The most
common elements include: Keywords app name & icon app
description preview screenshots (typically multiple screen shots
revealed by swiping) user reviews (list will grow with time)
customers also bought (may change with time) More apps provided by
manufacturer X (list will grow with time) The three latter elements
would require continued monitoring by the manufacturer.
Slide 50
Asclepius Asclepius Patient Helper
Slide 51
App Store: KEYWORDS/DESCRIPTION - Your one stop shop for
information on Jensulin - Learn about Jensulins effect on HbA1c,
hypoglycemia and weight - Teaching aids for instructing patients
about diabetes, insulin, injections, their devices, and more -
Guides for helping your patients improve their lifestyle and
exercise with diabetes Jensulin Jennsulin Gensulin Jensalin Blood
sugar Diabetes Drug information Prescribe PAABPharma Safe Keywords:
Subject to consumer regulations (name, price, quantity); should not
identify the therapeutic area Visuals: Screen shots are generally
captured from the app The current visuals would identify the
therapeutic area. Need to be revised Description: Also subject to
consumer regulations. Remove discussion of therapeutic area
PAABPharma
Slide 52
App Store: REVIEWS 1. This app provided me with all the info I
needed to confidently prescribe my diabetes patient Jensulin 2.
This app was no good. Froze all the time. Hard to find information
I was looking for. Print outs would not load. 3. Jensulin saved my
diabetes patients life. This app gave me so much information. Was
easy to follow. Would recommend this app and Jensulin to anyone. 4.
Hypoglycemia symptoms chart was not complete or user friendly.
Options: Monitor Deactivate Reviews section PAABPharma Identifies
therapeutic area Absolute claims, identifies therapeutic area
Identifies therapeutic area Ok
Slide 53
App Store: RELATED APPS Endeavour - Patient Support Lifestyle
FREE Eating Well with Diabetes Food & Drink FREE Insulin Device
Center Education Living with Diabetes Lifestyle Healthy Eating Food
& Drink Talking Tom Cat Entertainment Childhood Diabetes
Education Options: Monitor Remove/Deactivate this function
PAABPharma
Slide 54
After installation onto the users device: The patient
encounters this screen Once validated as a patient, the user has
access to all app features including a direct link into the patient
website.
Slide 55
Summary Digital media is subject to all the rules, regulations,
policies and guidance that exists for drug advertising and other
activities delivered by traditional media Consider your audience
and drug schedule first Then assess: Content Access Fair Balance
Linkage