Transcript File - PAAB Training Portal

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