1. Creating, Selecting and Positioning of Fair Balance in HCP drug advertising Malika Ladha PAAB Reviewer malikal@paab.ca

2. Fair Balance Fair Balance in the PAAB code Creating the three levels of fair balance Selecting the level of fair balance Positioning fair balance Fair balance requirements for non- prescription healthcare products (e.g. OTC, NHP)

3. Fair Balance In alignment with section 9.1 of the Food and Drugs Act, the PAAB Code sections 2.1, 2.4, 3.5 and 7.3 require that risk information be: – Presented within the APS among the claims (s2.1.2) – APS must reflect an attitude of caution (s2.4) – Emphasis only on positive features of a drug while ignoring negative findings is not acceptable (s3.5) – Comprised of content type and quantity which adequately balances the claims – Accurate, Clear, Prominent

4. PAAB code Rx&D requested that the PI (Product Information) be replaced with a link to the Product Monograph A committee of industry experts convened on how to meet the above requirements in the context of changes to PAAB code s7.3 New PAAB code took effect on July 1, 2013 Guidance documents created to assist in implementing the code changes

5. Guidance Documents

6. Creating the three levels of Fair Balance

7. Creating Fair Balance There are 3 levels of FB: See the guidance document “Guidance on Generating the Three Base Fair balance Levels” on the PAAB website Highest Middle Lowest Decreased comprehensive- ness Note: when highest level FB is required, PAAB allows option to use middle FB within an APS to direct HCP elsewhere within the same media for highest level FB.

8. Constructing the Highest Level of base Fair Balance Copy Framework:

9. Indications and Clinical Use: Must appear verbatim at least once in the APS (s2.10.2), among or prior to first set of marketing benefit claims (s2.10.1) Don’t need to repeat the indication (change section heading) Contraindications: Include all contraindications except those which are standard across all products (i.e. allergy to product or ingredient/packaging) Separate bullet points Constructing the Highest Level of base Fair Balance

10. Most Serious Warnings & Precautions: Summary of emphasized W&P from PM (e.g. bolded, boxed, all-caps, underlined, or described as "serious" or equivalent) are described. Bolded topic followed by description of the warning Secondary Malignancies: The following secondary malignancies have occurred, cutaneous squamous cell carcinoma, new primary melanomas and non-cutaneous malignancy. Each risk description is separated by a white space Constructing the Highest Level of base Fair Balance

11. Other relevant warnings & precautions: Only need to include the topic, not a description (point is to identify the W&P, directing the HCP to the TMA for more information) Separate bullet point for each individual warning Can be grouped together if done so in TMA or if considered to be adequately descriptive Be sure to identify if warning is in patients with a preexisting condition, or if it is a side effect of the drug Constructing the Highest Level of base Fair Balance

12. For more information: Direct reader to complete TMA (link) for information not included in the fair balance Must include link to the current TMA Documents are available upon request through a stated phone number Example: For More Information: Please consult the product monograph at www.websitepage.ca for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The product monograph is also available by calling us at 1-800-XXX-XXXX

13. What can the link lead to? Page housing TMA on the product website Search page on the Health Canada Drug Product Database Directly to a PDF of the TMA on the corporate page www.toviaz.ca/PM1583 http://webprod5.hc-sc.gc.ca/dpd- bdpp/index-eng.jsp http://www.pfizer.ca/en/our_prod ucts/products/monograph/317

14. Tips for Highest level fair balance There is no need to include content relating to indications which are not promoted in the APS Content may be summarized provided the complete essence is captured. No need to repeat info presented elsewhere in the APS (section heading should reflect not complete) – Manufacturers may still elect to spread fair balance throughout the APS. Risk elements which are bolded/boxed in the product monograph are not required to be bolded/boxed in the fair balance presentation: Some content can be omitted at the manufacturer’s discretion: – See page 11 appendix in guidance document for content that can be removed from FB Constructing the Highest Level of base Fair Balance

15. Appendix from the Supplement: Guidance on Generating the Three Fair Balance Levels The following can be removed from the Fair Balance copy (at the discretion of the Advertiser): Content which applies to all categories of drugs irrespective of therapeutic area – e.g. contraindications in patients with known allergies to the product or its ingredients – e.g. only use in those who are pregnant/nursing where benefits exceed risk Instructions which are covered by standards of practice for all drugs – e.g. instruct patients to keep out of reach of children – e.g. only physicians who are knowledgeable with the product or class should prescribe Copy which has been presented elsewhere in the advertisement/APS Copy which is promotional

16. The following can be removed from the Fair Balance copy (at the discretion of the Advertiser): Copy describing risks which have not been demonstrated to be associated with the product – e.g. Product was shown not be associated with weight gain Copy about alternative therapeutic options in case of adverse effects on the advertisers product – E.g. Dietary restrictions on Brand X may not extend to other products in the class, another product within the class maybe tried with caution Explanations why the product is contraindicated in certain populations Medical definitions and thresholds (except if within the indication statement) Appendix from the Supplement: Guidance on Generating the Three Fair Balance Levels

17. Example – JENSULIN FB Highest level of fair balance on the last page of a multiple page leave behind Indication placed on the first page of the APS with first set of marketing benefit claims

18. Indications and clinical use: JENSULIN [sublingual basal insulin praspart] 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 Caution in elderly patients (≥65 years of age) as they are more likely to have impaired renal function Contraindications: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container Serious warnings and precautions: Hypoglycemia: Most common adverse effect of insulin, including JENSULIN Glucose monitoring is recommended Uncorrected hypo- or hyperglycemia can cause loss of consciousness, coma or death Administration: Changes to insulin should be made cautiously and only under medical supervision Not intended to be eaten or administrated as a suppository Must not be mixed with any other insulin Other relevant warnings and precautions: Hypokalemia Sodium retention and edema Patients with human insulin antibodies Combination of TZD with insulin is not indicated for the treatment of Type 2 Diabetes Mellitus Hyperglycemia and diabetic ketoacidosis Patients with oral inflammation or oral wounds Local and systemic allergic reactions, antibody production Patients with hepatic or renal impairment For more information: Please consult the JENSULIN Product Monograph at www.jensulin.ca for important information relating to adverse reactions, drug interactions and dosing information, which have not been discussed in this piece.www.jensulin.ca Fair balance headings must be bolded Can be revised to “Clinical use” and indication statement can be removed from the section “Contraindications” section can be removed Revise to “Most serious warnings and precautions” Insert line of white space Should be a direct link to the TMA Statement that the Product Monograph is available through a stated phone number

19. Constructing the Middle Level of Fair Balance Copy Framework Indication statement unless stated elsewhere in the APS, e.g. Headline Consult the Product Monograph at www.Xgeva.ca/PM for important information on:www.Xgeva.ca/PM Contraindications in… Most serious warnings and precautions… Other relevant warnings and precautions… Conditions of clinical use, adverse reactions, drug interactions and dosing instructions The product monograph is also available by calling us at 1-800-xxx-xxxx.

20. JENSULIN Middle Level of Fair Balance JENSULIN [sublingual basal insulin praspart] 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. Consult the product monograph at www.jensulin.ca/JENSULINTMA for important information about:www.jensulin.ca/JENSULINTMA Most serious warnings and precautions regarding hypoglycemia and administration Other relevant warnings and precautions regarding hypokalemia, sodium retention and edema, patients with human insulin antibodies, combination of TZD with insulin in the treatment of Type 2 Diabetes Mellitus, hyperglycemia and diabetic ketoacidosis, patients with oral inflammation or oral wounds, local and systemic allergic reactions, antibody production, patients with hepatic or renal impairment Conditions of clinical use, adverse reactions, drug interactions and dosing instructions The Product Monograph is also available through our medical department. Call us at at 1-800-123-4567.

21. Constructing the Lowest Level of Fair Balance Indication statement unless stated elsewhere in the APS Consult the Product Monograph at www.Xgeva.ca/PM for important information on contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The Product Monograph is also available by calling us at 1- 800-xxx-xxxx. www.Xgeva.ca/PM

22. JENSULIN Lowest Level of Fair Balance JENSULIN [sublingual basal insulin praspart] 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. Consult the product monograph at www.jensulin.ca/JENSULINTMA for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical department. Call us at 1-800-123-4567.www.jensulin.ca/JENSULINTMA

23. Indications and clinical use: JENSULIN [sublingual basal insulin praspart] 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 Caution in elderly patients (≥65 years of age) as they are more likely to have impaired renal function Most serious warnings and precautions: Hypoglycemia: Most common adverse effect of insulin, including JENSULIN Glucose monitoring is recommended Uncorrected hypo- or hyperglycemia can cause loss of consciousness, coma or death Administration: Changes to insulin should be made cautiously and only under medical supervision Not intended to be eaten or administrated as a suppository Must not be mixed with any other insulin Other relevant warnings and precautions: Hypokalemia Sodium retention and edema Patients with human insulin antibodies Combination of TZD with insulin is not indicated for the treatment of Type 2 Diabetes Mellitus Hyperglycemia and diabetic ketoacidosis Patients with oral inflammation or oral wounds Local and systemic allergic reactions, antibody production Patients with hepatic or renal impairment For more information: Please consult the JENSULIN Product Monograph at www.jensulin.ca/JENSULINTMA for important information relating to adverse reactions, drug interactions and dosing information, which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-123- 4567. www.jensulin.ca/JENSULINTMA Consult the product monograph at www.jensulin.ca/JENSULINTMA for important information about:www.jensulin.ca/JENSULINTMA Most serious warnings and precautions regarding hypoglycemia and administration Other relevant warnings and precautions regarding hypokalemia, sodium retention and edema, patients with human insulin antibodies, combination of TZD with insulin in the treatment of Type 2 Diabetes Mellitus, hyperglycemia and diabetic ketoacidosis, patients with oral inflammation or oral wounds, local and systemic allergic reactions, antibody production, patients with hepatic or renal impairment Conditions of clinical use, adverse reactions, drug interactions and dosing instructions The Product Monograph is also available through our medical department. Call us at at 1-800-123-4567. Consult the product monograph at www.jensulin.ca/JENSULINTMA for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical department. Call us at 1-800-123-4567.www.jensulin.ca/JENSULINTMA

24. Selecting the level of Fair Balance

25. Dependent on the type of claims in the APS Selecting Fair Balance Level: Highest Middle Lowest Decreased comprehensive- ness Therapeutic claims Pharmacologic claims No pharmacologic claims

26. Selecting Fair Balance Level: Highest level required if APS contains any of the following: Therapeutic claim (e.g. efficacy, safety, tolerability) Compliance/adherence claim Place in therapy claim (e.g. 1 st line treatment) Pharmacoeconomic claim Beneficial aspects of risk/burden profile from TMA If not (aside from indication), go to next slide…

27. Middle level required if APS contains any of the following: Pharmacologic claims other than any of those listed on prior slide (e.g. pharmacokinetics/pharmacodynamic), Presentations describing predefined measured endpoints from clinical trials without disclosing results (e.g. ongoing studies) If not (aside from indication), go to next slide… Selecting Fair Balance Level:

28. Lowest level required if APS contains any of the following: non-pharmacologic claims healthcare product messages other than marketing benefit claims (e.g. cautionary content) messages which do not relate to the healthcare product (e.g. disease information) Selecting Fair Balance Level:

29. Examples of non-pharmacological claims –market positioning/experience claims –Tablet characteristics/sensory characteristics (i.e. taste/smell) –cost comparisons –cosmetic/packaging/device characteristics –study characteristics without mention of endpoints (e.g. “largest published RCT in diabetes”) –plea to choose/prescribe the product or plea to write “do not substitute” if physician wants to ensure patient receives brand X –claims relating to instructions for use, dosage and or administration information (whether comparative or non-comparative) provided the claim does not allude, in any way, to topics discussed in slide 1 If not, consider whether exempt per s6.6. If unsure submit for an opinion.

30. How the drug interacts with the body in a therapeutic way How the drug interacts with the body in a non-clinical way Claims that don’t relate to an interaction between the product and the body None of the above? Is this piece exempt (s6.6)?

31. Testing your FB knowledge Which level of FB would you choose? 1)The first and only once-daily antihypertensive therapy 2)A new dose delivery system. Demonstrated safety profile 3)For patients with irritable bowel syndrome NOTE: If after a trial of 2 weeks, patient continues to experience similar side effects and no greater efficacy than previous therapy, continued use should be reassessed. 4)New Rizaren Tablet for ulcerative colitis Rizaren tablets have microgranules that provide predictable, uniform drug release and delivery. L H L M

32. Positioning of Fair Balance

33. Indication statement – Must appear verbatim in the APS (s2.10.2) – Must appear prior to or among the first set of marketing benefit claims (s2.10.1) A statement that is designed to promote the sale of a health product It often promotes a specific product attribute

34. Positioning of Fair Balance Risk information should be where the claims are (meaning in the same parts of the APS). Risk information should be accorded a degree of prominence which is similar to the claim content.

35. Positioning of Fair Balance General Requirements: – Fair balance should be visually comparable to body copy – Factors to consider in assessing prominence: type size (at least 75% of body copy) spacing duration, pace contrast/shade Readability location

36. General Requirements – Fair balance should generally not be presented below product logos (+/- tagline), references, legal mice type and/or footnotes – These elements tend to mark the end of the advertising message portion on a surface Positioning of Fair Balance

37. Corporate signoff Footnotes Product logo

38. Positioning of Fair Balance Middle to Highest level fair balance When highest level of fair balance is required you have the option to use middle fair balance direct the reader to the highest level fair balance

39. Linking Middle to Highest Fair Balance : The highest fair balance must be within the same tool (or directly attached to it) AND in the same media. – pull out the dosing ruler to reveal the highest fair balance. – electronic banner ad directs reader to click a link which takes him/her directly to the highest fair balance. The middle fair balance must lead directly to highest level fair balance. Access to the highest fair balance should require little to no effort in day- to-day use of the piece. Surface must be easy to read

40. Middle fair balance must be: Within the main advertising message Wording must be adjusted to reflect language directing to the highest level fair balance Linking Middle to Highest Fair Balance :

41. 41 High Level of Fair Balance

42. Middle Level of Fair Balance 42

43. … with High Level Fair Balance Option

44. Positioning of Fair Balance Linear tools vs. non-linear tools Websites – Safety information should appear on homepage/surface – Safety information tab in menu items which is accessible from all screens (links to highest level of fair balance)

45. Example: Dosing Slide-out Ruler

46. Fair Balance for non-prescription healthcare products (s2.4.3)

47. Fair balance requirement can* be met by: For products with a Product Monograph (PM) Fair Balance statement required: “Please consult the Product Monograph available at [insert link to the PM] for information to assist in benefit- risk assessment. Always direct the patient to read the label” (s2.4.3i) “See Warnings, Cautions, and Directions of Use at [insert link to the TMA] for information to assist in benefit-risk assessment. Always direct the patient to read the label” (s2.4.3ii) For products without a PM -Fair balance statement must be accompanied by statement with phone # to access TMA -Electronic APS: phone # is not needed if electronic link provided to the TMA -Indication must appear within the APS (s2.10) *Not required if all relevant TMA info on ad

48. “All Relevant” means (s7.2.1) Medicinal ingredients (s11) The approved use All of the following relating to the promoted use: – Cautions & warnings – Contraindications – Interactions – Known adverse events – Dosing info

49. s2.4.3i) of PAAB Code

50. Summary of Fair Balance How to create the three levels of fair balance How to select the level of fair balance required based on the claims in the APS Where to position the fair balance copy in the APS Any questions??