Malika Ladha malikalpaabca PAAB Reviewer Exploring product branded advertising vs editorial advertising vs corporate advertising s6164 74 75 2 What is Drug Advertising Definition in section 2 of the Food amp Drugs Act ID: 748675
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Exploring APS categories
Malika Ladhamalikal@paab.caPAAB Reviewer
Exploring product branded advertising vs. editorial advertising vs. corporate advertising
(s6.1-6.4, 7.4, 7.5)Slide2
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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”Slide3
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Still unsure?
See
“
Distinction Between Advertising and Other Activities
”
on the Health Canada websiteSlide4
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 claimsOnly message is “now on formulary”Only message is “Available at company X”APS only comprised of packshot with no therapeutic claims are visibleSlide5
Targeting patients:
PAAB s6.4.3Can: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.Slide6
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 productDoes NOT contain identifiable branding elements for the sponsor’s productSlide7
Editorial (s7.5)Slide8
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 classificationCan NOT contain therapeutic claims or other claims of product merit or statusSlide9
Corporate (s7.4)Slide10
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 AdvertisingHealth 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.phpSlide11
Targeting consumers
For non-advertising information:
Need to consider the relevant provisions from the “Distinction” Document
Examples:Help-Seeking AnnouncementsConsumer BrochuresFor advertising:
Need to consider product’s federal schedule & whether disease/condition treated is on schedule A. Slide12
Consumer InformationSlide13
Consumer BrochureSlide14
Consumer AdvertisingSlide15
Federal Drug Schedules
Narcotic
Schedule G – controlled drugs
Prescription drugsSchedule 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)”Slide16
Disease Consideration - Schedule A
Acute alcoholism
Acute anxiety state
Acute infectious respiratory syndromes Acute psychotic conditionsAcute, inflammatory and debilitating arthritis
Addiction, except nicotine addictionAppendicitisArteriosclerosis
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.htmlSlide17
Consumer Product
Advertising Key Considerations
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 c01.044a 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 CanadaSchedule D products may make therapeutic claims to public except for schedule A prohibition (fair balance required)Slide18
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).Slide19
Consumer advertising/info:
What PAAB does for you.
Provides advisory service
Turnaround 4 daysReview based on Health Canada policy documents:Distinction Between Advertising and Other ActivitiesConsumer Advertising Guidelines for Marketed Health
ProductsPrinciples for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug ProductsTherapeutic Comparative Advertising: Directive and Guidance Document
PAAB has been doing DTC reviews since 1990Slide20
Questions?