Transcript Jensulin - PAAB Training 2016

Digital Media
Exploring how the advertising regulations
apply to digital media such as websites,
banners, SEO, SEM, and apps.
(s.6.5)
Malika Ladha
PAAB Reviewer
[email protected]
Agenda
• Key considerations:
• Access, Content, Linkage and Fair balance
• Exploring these across an array of digital tools
•
•
•
•
Websites
Banner Ads
SEO/SEM
Apps
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)?
WEBSITES (S.6.5.8)
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.
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
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
Website: ACCESS CONTROL (s.6.5.6)
• Unacceptable barriers
– Registration and/or attestation alone are NOT sufficient
barriers
Website: CONTENT (s.6.5.8)
• 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
OVERVIEW:
Jensulin vs. Passad demonstrated:
• Significant reduction in A1C
• Similar decrease in FPG and PPG
• Reduced incidence of nocturnal
hypoglycemia
Website: BALANCING COPY (s.6.5.8, 2.4)
• 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
www.Jensulin.ca/12390
About Jensulin
Patient Profiles
Diving into the Evidence
Jensulin Injections
Safety Information
Patient Counselling
Resources
Frequently Asked Question
Guideline Recommendations
Get a
Device
Website:
BALANCING COPY
Website: LINKAGE (s.6.5.4)
•
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.
BANNER ADS (S.6.5.5)
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: CONSUMER
Facebook:
Jensulin
www.Jensulin.ca
PAABPharma
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.
Banner Ad: HCP
Frame 1
Pfizer
Frame 2
Frame 3
Indication with first
promotional claim?
Once daily sublingual basal insulin
Demonstrated:
Significant reduction in A1C vs insulin passad (p=0.01)
-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 passad1
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=0.0211
Click here to learn more
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
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 1.888.357.3243
PAABPharma
Highest level fair
balance?
Indication upfront
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
PAABPharma
Rotating banners
Once daily sublingual basal insulin
Demonstrated:
Significant reduction in A1C vs insulin passad (p=0.01)
-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 passad1
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=0.0211
Option 1: Highest Level Fair Balance
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
PAABPharma
• Presenting highest level fair balance within the rotating
banner ad
Option 2: Middle linking to highest level fair balance
Link to TMA directly
Highest level
fair balance
PAABPharma
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
Option 3: Middle linking to highest level fair balance on link destination
Highest level
fair balance
Note: This site now
requires review
PAABPharma
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
Banner Ad: HCP LINKAGE (s.6.5.4)
Frame 1
Frame 2
Pfizer
Clicking takes you to www.celebrex.ca
www.celebrex.ca
Banner Ad: LINKAGE (s.6.5.4)
Frame 1
Pr
Banner Ad: HCP
Frame 2
Pr
Banner Ad: HCP
Frame 3
for additional safety information and a link to the product monograph for information
Pr
Czech Tec
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
HCP EMAIL
SEARCH ENGINE OPTIMIZATION (SEO) &
MARKETING (SEM) (S.6.5.10, S.6.5.11)
SEO/ SEM (s.6.5.10, 6.5.11)
Search Engine Optimization (s.6.5.10)
• Meta data text provided by the manufacturer (or it’s
agent) to a search engine for PAAB approved
website:
• Must not exceed consumer advertising
regulations.
• Must not refer to competitor products
URL
Title tag
Meta description
Jensulin.ca
Jensulin
Jensulin.ca, an online resource Taking Jensulin?
designed to provide valuable
information about Jensulin for
healthcare professionals,
diabetes patients and the
general public.
Diabetes
Jensulin.ca/ Jensulin Patient
patientlogin login
Jensulin patient information
Taking Jensulin?
Diabetes Patient
Jensulin.ca/ Jensulin HCP
hcplogin
login
Jensulin information for
healthcare professionals
Jensulin for
healthcare
professionals
Healthcare
professional
Jensulin.ca/ Talk to your
talktodoctor doctor
H1 tag
Help talking to
doctors
Jensulin.ca/ Dangers of
realdeal
counterfeit drugs
See icebreakers to help you
talk to your doctor about
hypoglycemia, low blood sugar
and more.
Learn the dangers of
counterfeit products
Jensulin.ca/ Jensulin
seenontv
Commercials
See the latest Jensulin
commercials online
KeywordsSeen on
TV
Dangers of
counterfeit drugs
Keywords
Insulin
Glycemic control
Hypoglycemia
Diabetes treatment
Talk to your doctor
about low blood
sugar
Counterfeit
Real Jensulin
REVISED CONTENT
URL
URL
Title
Titletag
tag
Jensulin.ca Jensulin
Jensulin
Jensulin.ca
Meta
Meta
description
description
H1H1
tagtag
Jensulin.ca,
anan
online
resource
Jensulin?
Jensulin.ca,
online
resourceTaking
Taking
Jensulin?
designed
toto
provide
valuable
designed
provide
valuable
information
about
Jensulin
forfor
information
about
Jensulin
healthcare
professionals,
healthcare
professionals,
diabetes
patients
and
the
diabetes
patients
and
the
general
public.
general
public.
Keywords
Keywords
Diabetes
Diabetes
Insulin
Insulin
Glycemic
control
Glycemic
control
Hypoglycemia
Hypoglycemia
Jensulin.ca/ Jensulin
JensulinPatient Jensulin
patient
information
Jensulin.ca/
Jensulin
patient
information
patientlogin login
Patient login
patientlogin
Taking
Jensulin?
Patient
Taking
Jensulin? Diabetes
Diabetes
Patient
Jensulin.ca/
Jensulin.ca/ Jensulin
JensulinHCP
HCP
hcplogin
login
hcplogin
login
Jensulin
Jensulin
forfor
healthcare
healthcare
professionals
professionals
Jensulin
information
Jensulin
information
forfor
healthcare
professionals
healthcare
professionals
Jensulin.ca/
Jensulin.ca/ Talk
Talktotoyour
your
talktodoctor
talktodoctor doctor
doctor
Healthcare
Healthcare
professional
professional
Diabetes
treatment
Diabetes
treatment
Talk
your
doctor
Talk
toto
your
doctor
about
low
blood
about
low
blood
sugar
sugar
See
icebreakers
help
you Help
Help
talking
See
icebreakers
toto
help
you
talking
to to
talk
your
doctor
about
doctors
talk
toto
your
doctor
about
doctors
hypoglycemia,
low
blood
sugar
hypoglycemia,
low
blood
sugar
and
more.
and
more.
Jensulin.ca/
Learn
the
dangers
Dangers
Counterfeit
Jensulin.ca/ Dangers
Dangersofof
Learn
the
dangers
ofof
Dangers
of of
Counterfeit
realdeal
counterfeit
counterfeit
products
counterfeit
drugs Real Jensulin
realdeal
counterfeitdrugs counterfeit
products
counterfeit
drugs
Real Jensulin
drugs
Jensulin.ca/
Jensulin.ca/
seenontv
seenontv
Jensulin
Jensulin
Commercials
Commercials
See
the
latest
Jensulin
See
the
latest
Jensulin
commercials
online
commercials
online
KeywordsSeen
KeywordsSeen
onon
TVTV
SEO/ SEM (s.6.5.10, 6.5.11)
Search Engine Marketing (s.6.5.11)
• Meta data requirements are the same as SEO
with the addition of sponsor purchased
keywords (s.6.5.11)
– These cannot exceed the regulations
– Evaluated in the context of the other material that will
show upon search
• I.e. User generate keyword + metadescriptor +
landing page + URL should not exceed that which
is permissible for the sponsors product
Ad related to Jensulin
Jensulin | Jensulin.ca
www.Jensulin.ca
Learn about diabetes treatment
Keywords:
Jensulin
Gensulin
Jennsulin
Jensalin
Insulin passad
Diabetes
Injection
HbA1c
Hyperglycemia
Hypoglycemia
Foot care
Blood sugar
Safety profile
Prescribe
Ad related to Jensulin
Jensulin | Jensulin.ca
www.Jensulin.ca
Learn about diabetes treatment
Keywords:
Jensulin
Gensulin
Jennsulin
Jensalin
Insulin passad
Diabetes
Injection
HbA1c
Hyperglycemia
Hypoglycemia
Foot care
Blood sugar
Safety profile
Prescribe
APPS (S.6.5.9)
Linear vs. Non-linear
• Linear:
– Rep-driven e-details aids
– Piece is intended to be presented in a specific sequences
– Different set flows require review under separate eFiles
• Non-linear:
– Self-driven apps
– Access: Consider App Store and gating once downloaded
– Same fair balance requirements as websites (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 app).
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.
Asclepius Patient Helper
Asclepius
App Store: KEYWORDS/DESCRIPTION
PAABPharma
- 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
• 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
After installation onto the user’s 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.
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
Now go get Digital! Digital!