Let’s get digital. Digital. I wanna get digital. (Playfully adapted from Olivia Newton-John’s song) Exploring how the advertising regulations apply to digital media such as websites, banners, SEO, SEM, social media and apps. (s.6.5)

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

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 ) 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, – 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 )

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 )

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 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 )

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 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 hypoglycemia The number of events with Jensulin vs insulin passad: 18 vs 42; p= % 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?

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 It is also available through our medical department. Call us at www.PAABPharma.ca\JensulinPM 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 hypoglycemia The number of events with Jensulin vs insulin passad: 18 vs 42; p= % 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

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 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 Option 1: 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 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 Highest level fair 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 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

Frame 1 Frame 2 Clicking takes you to Pfizer Banner Ad: HCP LINKAGE (s.6.5.4)

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

Banner Ad: HCP

Banner Ad: HCP - body

SEARCH ENGINE OPTIMIZATION (SEO) & MARKETING (SEM) (S , S )

SEO/ SEM (s , ) Search Engine Optimization (s ) 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

SEO/ SEM (s , ) Search Engine Marketing (s ) 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 competitor’s product as a keyword Non-Rx sponsored search ads containing claims must include Fair Balance.

DYNAMIC CONTENT (S.6.5.9)

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

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)

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)

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)

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 :

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

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

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

APPS (S.6.5.9)

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

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 Asclepius 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 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

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

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

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!