Exploring APS categories Exploring product branded advertising vs. editorial advertising vs. corporate advertising (s6.1-6.4, 7.4, 7.5) Malika Ladha [email protected] PAAB Reviewer 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” 2 Still unsure? See “Distinction Between Advertising and Other Activities” on the Health Canada website 3 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 Targeting patients: PAAB s6.4.3 Can: Create linkage between the product and it’s therapeutic use irrespective of the federal schedule. Can’t: Be promotional. Note: All product content must be derived from part III. 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 Editorial (s7.5) 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 Corporate (s7.4) 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 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 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. Consumer Information Consumer Brochure Consumer Advertising 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)” 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-lois.justice.gc.ca/eng/acts/f-27/page-14.html Consumer Product Advertising Key Considerations 1. Non gated → accessible to the general public 2. Food and Drugs Act and Regulations: – Advertising of a prescription 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) 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). 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 Questions?