1. Advertising, APS categories and target audiences Dannie Newman Reviewer dannien@paab.ca www.paab.ca

2. Agenda Advertising vs non-advertising PAAB APS Categories – Advertising with Product Claims – Editorial HCP ads – Corporate HCP ads Target Audiences – HCP – Patient – Consumer Advertising/Information

3. 3 What is Drug Advertising? Definition in section 2 of the Food & Drugs Act: “Any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device”

4. 4 Still unsure? See “Distinction Between Advertising and Other Activities” on the Health Canada website

5. Distinction Between Advertising and Other Activities: What is the context in which the message is disseminated ? Who are the primary and secondary audiences ? Who delivers the message (the provider) ? Who sponsors the message and how ? What influence does the drug manufacturer have on the message content ? What is the content of the message ? With what frequency is the message delivered ?

6. Breaking down the 7 questions. 2 separate groups of factors 1. Content /creation factors: What is the content ? Who sponsors the message and how ? Extent of drug manufacturer influence over message content ? 2. Distribution/availability factors Audience ? Context of dissemination ? Who delivers ? Frequency of delivery ?

7. “No one factor in itself will determine whether or not a particular message is advertising.” …If uncertain, don’t hesitate to ask PAAB. We’ll respond to requests for written opinions within 4 days.

8. If it is product advertising… …and it is directed to HCPs, PAAB review is required. Exceptions are listed in PAAB code 6.6(d): – Company price lists containing no other product/company claims – Only message is “now on formulary” – Only message is “Available at company X” – APS only comprised of packshot with no therapeutic claims are visible

9. Agenda Advertising vs non-advertising PAAB APS Categories – Advertising with Product Claims – Editorial HCP ads – Corporate HCP ads Target Audiences – HCP – Patient – Consumer Advertising/Information

10. Advertising with Product Claims Branded APS Must contain fair balance copy and prescribing information

11. Editorial (s7.5) What is an editorial? Used to present information relative to a therapeutic area the sponsor has a vested interest in Does NOT focus on a specific product Does NOT contain identifiable branding elements for the sponsor’s product

12. Editorial (s7.5)

13. Linkage principles Branded and unbranded disease info Product ad and editorial ad Internet links Product Package shot If you join “advertising” and “non- advertising”, everything becomes “advertising”

14. Linking Linking factors include: 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.

15. Corporate (s7.4) What is a corporate APS? Used to create and maintain a favourable image of a company, its products and its services CAN contain product names along with their therapeutic or pharmacologic classification Can NOT contain therapeutic claims or other claims of product merit or status

16. Institutional/corporate (s7.4)

17. Agenda Advertising vs non-advertising PAAB APS Categories – Advertising with Product Claims – Editorial HCP ads – Corporate HCP ads Target Audiences – HCP – Patient – Consumer Advertising/Information

18. Target your message to match your audience

19. Three regulatory audiences: HCP: Messaging directed to licensed members of the professions of medicine, dentistry, naturopathy, nursing, pharmacy and related health disciplines and institutions. Patient: Messaging directed to individuals prescribed that product OR messaging in a tool intended for use by HCPs only during counseling. Consumer: Messaging directed to the general public. Readily accessible by individuals who have not been prescribed the product.

20. BUT… Are there secondary audiences?

21. Secondary audiences Those who can readily access the content but aren’t the intended audience

22. For example… Non-gated website targeted to HCPs Must consider consumer regulations in addition to PAAB code. Examination room poster Must consider consumer regulations in addition to PAAB code.

23. PAAB preclearance services: PAAB code covers HCP Advertising (whether product branded, editorial, or corporate ad with product mention or relating to a product) Patient Information provided through HCPs (s6.4) PAAB advisory service (using Health Canada policy documents): Consumer Information Consumer Advertising Health Canada and Advertising Preclearance Agencies’ Roles Related to Health Product Advertising: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php

24. Targeting consumers For non-advertising information: Need to consider the relevant provisions from the “Distinction” Document Examples: Help-Seeking Announcements Consumer Brochures For advertising: Need to consider product’s federal schedule & whether disease/condition treated is on schedule A. Example: Rx drug reminder ads (C.01.044 of the Food & Drugs Regulations)

25. Consumer Information

26. Help-Seeking Announcement

27. Consumer Brochure

29. Consumer Advertising

30. Federal Drug Schedules Narcotic Schedule G – controlled drugs Prescription drugs Schedule D – biological products (e.g. vaccines, insulins). Caution: Some are dual scheduled products. Non-scheduled (including NHPs, EN-NHPs, homeopathic, OTC) Note that an ethical drug is a product that does not require an Rx but that is generally prescribed (e.g. MRI contrast agent, hemodialysis solutions, nitroglycerine, emergency adrenergic agonists). Adapted from Health Canada document “Terminology - Drug Product Database (DPD)”

31. Disease Consideration - Schedule A  Acute alcoholism  Acute anxiety state  Acute infectious respiratory syndromes  Acute psychotic conditions  Acute, inflammatory and debilitating arthritis  Addiction, except nicotine addiction  Appendicitis  Arteriosclerosis  Asthma  Cancer  Congestive heart failure  Convulsions  Dementia  Depression  Diabetes Gangrene Glaucoma Haematologic bleeding disorders Hepatitis Hypertension Nausea and vomiting of pregnancy Obesity Rheumatic fever Septicaemia Sexually transmitted diseases Strangulated hernia Thrombotic and embolic disorders Thyroid disease Ulcer of the gastro-intestinal tract http://laws.justice.gc.ca/en/showdoc/cs/F-27/sc:1//en#anchorsc:1

32. Consumer Product Advertising Key Considerations 1.Non gated → accessible to the general public 2. Food and Drugs Act and Regulations: – Advertising of a prescription schedule drug to the general public is limited to name, price and quantity c01.044 – a drug (prescription or nonprescription) or medical device may not be advertised to the general public for the treatment or cure for a Schedule A disease (3.1) – Section A.01.067 of the Food and Drug Regulations provides exemptions for certain non-prescription drugs and NHPs; Schedule A preventative claims may be made if these claims have been authorized by Health Canada – Schedule D products may make therapeutic claims to public except for schedule A prohibition (fair balance required)

33. Consumer Product Advertising Key Considerations – The law prohibits any direct to consumer “Advertising” of narcotic drugs (Section 70 of the Narcotic Control Regulations) and controlled drugs (FDR: G.01.007).

34. Consumer advertising/info: What PAAB does for you. Provides advisory service Turnaround 4 days Review based on Health Canada policy documents: – Distinction Between Advertising and Other Activities – Consumer Advertising Guidelines for Marketed Health Products – Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products – Therapeutic Comparative Advertising: Directive and Guidance Document PAAB has been doing DTC reviews since 1990

35. Questions?