Digital Media
Exploring how the advertising regulations apply to digital media such as websites,
banners, SEO, SEM, and apps. (s.6.5)
Malika LadhaPAAB [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 forany 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 sponsorii) 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
• Unacceptable barriers– Registration and/or attestation alone are NOT sufficient
barriers
Website: ACCESS CONTROL (s.6.5.6)
• 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)
OVERVIEW:
Jensulin vs. Passad demonstrated: • Significant reduction in A1C
• Similar decrease in FPG and PPG
• Reduced incidence of nocturnal hypoglycemia
• 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)
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
Website: BALANCING COPY
• 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)
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:
Jensulinwww.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.
Frame 1 Frame 2 Frame 3
Pfizer
Banner Ad: HCP
Secondary outcomes: Demonstrated significant reduction in weight vs insulin passad-3.7lbs vs. insulin passad (p=0.001)1
Demonstrated a low incidence of hypoglycemiaThe number of events with Jensulin vs insulin passad: 18 vs 42; p=0.0211
-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
Demonstrated:Significant reduction in A1C vs insulin passad
(p=0.01)
Indication and clinical useJensulin 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 to learn more
Once daily sublingual basal insulin
Indication with first promotional claim?
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 instructionsThe product monograph is available at www.PAABPharma.ca\JensulinPM It is also available through our medical department. Call us at 1.888.357.3243
Highest level fair balance?
PAABPharma
Secondary outcomes: Demonstrated significant reduction in weight vs insulin passad-3.7lbs vs. insulin passad (p=0.001)1
Demonstrated a low incidence of hypoglycemiaThe number of events with Jensulin vs insulin passad: 18 vs 42; p=0.0211
-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
Demonstrated:Significant reduction in A1C vs insulin passad
(p=0.01)
Indication and clinical useJensulin 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
• Presenting highest level fair balance within the rotating banner ad
Indication and clinical useJensulin 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 hyperglycemiaMost 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 informationPlease 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
Indication and clinical useJensulin 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 hyperglycemiaMost 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 informationPlease 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 levelfair balance
Link to TMA directly
Option 2: Middle linking to highest level fair balance
PAABPharma
Option 3: Middle linking to highest level fair balance on link destination
Indication and clinical useJensulin 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 hyperglycemiaMost serious warnings and precautions Hypoglycemia is the most common adverse effect of insulin · Glucose monitoring is recommended
Highest levelfair balanceNote: This site now requires review PAABPharma
Frame 1 Frame 2
Clicking takes you to www.celebrex.ca
Pfizer
Banner Ad: HCP LINKAGE (s.6.5.4)
www.celebrex.ca
Banner Ad: LINKAGE (s.6.5.4)
Frame 1
Pr
Frame 2
Pr
Banner Ad: HCP
Frame 3
Pr
Czech Tec
Banner Ad: HCP
for additional safety information and a link to the product monograph for information
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 H1 tag Keywords
Jensulin.ca Jensulin Jensulin.ca, an online resource designed to provide valuable information about Jensulin for healthcare professionals, diabetes patients and the general public.
Taking Jensulin? Diabetes
Insulin
Glycemic control
Hypoglycemia
Jensulin.ca/patientlogin
Jensulin Patient login
Jensulin patient information Taking Jensulin? Diabetes Patient
Jensulin.ca/hcplogin
Jensulin HCP login
Jensulin information for healthcare professionals
Jensulin for healthcare professionals
Healthcare professional
Diabetes treatmentJensulin.ca/talktodoctor
Talk to your doctor
See icebreakers to help you talk to your doctor about hypoglycemia, low blood sugar and more.
Help talking to doctors
Talk to your doctor about low blood sugar
Jensulin.ca/realdeal
Dangers of counterfeit drugs
Learn the dangers of counterfeit products
Dangers of counterfeit drugs
Counterfeit
Real Jensulin
Jensulin.ca/seenontv
Jensulin Commercials
See the latest Jensulin commercials online
KeywordsSeen on TV
REVISED CONTENT
URL Title tag Meta description H1 tag Keywords
Jensulin.ca Jensulin Jensulin.ca, an online resource designed to provide valuable information about Jensulin for healthcare professionals, diabetes patients and the general public.
Taking Jensulin? Diabetes
Insulin
Glycemic control
Hypoglycemia
Jensulin.ca/patientlogin
Jensulin Patient login
Jensulin patient information Taking Jensulin? Diabetes Patient
Jensulin.ca/hcplogin
Jensulin HCP login
Jensulin information for healthcare professionals
Jensulin for healthcare professionals
Healthcare professional
Diabetes treatmentJensulin.ca/talktodoctor
Talk to your doctor
See icebreakers to help you talk to your doctor about hypoglycemia, low blood sugar and more.
Help talking to doctors
Talk to your doctor about low blood sugar
Jensulin.ca/realdeal
Dangers of counterfeit drugs
Learn the dangers of counterfeit products
Dangers of counterfeit drugs
Counterfeit
Real Jensulin
Jensulin.ca/seenontv
Jensulin Commercials
See the latest Jensulin commercials online
KeywordsSeen on TV
URL Title tag Meta description H1 tag Keywords
Jensulin.ca Jensulin Jensulin.ca, an online resource designed to provide valuable information about Jensulin for healthcare professionals, diabetes patients and the general public.
Taking Jensulin? Diabetes
Insulin
Glycemic control
Hypoglycemia
Jensulin.ca/patientlogin
Jensulin Patient login
Jensulin patient information Taking Jensulin? Diabetes Patient
Jensulin.ca/hcplogin
Jensulin HCP login
Jensulin information for healthcare professionals
Jensulin for healthcare professionals
Healthcare professional
Diabetes treatmentJensulin.ca/talktodoctor
Talk to your doctor
See icebreakers to help you talk to your doctor about hypoglycemia, low blood sugar and more.
Help talking to doctors
Talk to your doctor about low blood sugar
Jensulin.ca/realdeal
Dangers of counterfeit drugs
Learn the dangers of counterfeit products
Dangers of counterfeit drugs
Counterfeit
Real Jensulin
Jensulin.ca/seenontv
Jensulin Commercials
See the latest Jensulin commercials online
KeywordsSeen on TV
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
Keywords: JensulinGensulinJennsulinJensalinInsulin passadDiabetesInjectionHbA1cHyperglycemiaHypoglycemiaFoot careBlood sugarSafety profilePrescribe
Ad related to Jensulin
Jensulin | Jensulin.cawww.Jensulin.ca
Learn about diabetes treatment
Keywords: JensulinGensulinJennsulinJensalinInsulin passadDiabetesInjectionHbA1cHyperglycemiaHypoglycemiaFoot careBlood sugarSafety profilePrescribe
Ad related to Jensulin
Jensulin | Jensulin.cawww.Jensulin.ca
Learn about diabetes treatment
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 StoreThe 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.
AsclepiusAsclepius Patient Helper
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
• 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
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!