Digital Media

Exploring how the advertising regulations apply to digital media such as websites,

banners, SEO, SEM, and apps. (s.6.5)

Malika LadhaPAAB Reviewermalikal@paab.ca

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!