Drug Advertising

Question 1

What are the only two countries that allow direct-to-consumer advertising for prescription drugs, including name and indication?

Answer 1

New Zealand and USA

Question 2

What is health product advertising?

Answer 2

any representation, by any means for the purpose of promoting directly or indirectly the sale or distribution of any health product
-not all messages which refer to health products considered to be advertising (press releases, brochures, exhibits, articles, etc)

Question 3

What are unsolicited requests for information?

Answer 3

information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way is not considered to be advertising for the sale of a drug

Question 4

What is the role of advertising preclearance agencies?

Answer 4

review and preclear advertising material in order to help the pharmaceutical industry ensure compliance with the regulatory provisions

Question 5

Before being used, who must clear all DTCA for pharmaceuticals in Canada?

Answer 5

Pharmaceutical Advertising Advisory Board (PAAB)
and/or Ad Standards

Question 6

Which population must DTCA be directed explicitly towards?

Answer 6

adults
-children are not capable of making rational decisions regarding the use of advertised drugs

Question 7

Describe PAAB.

Answer 7

self-regulated, independent, not-for-profit review agency
ensures that healthcare product communication is compliant with federal legislative regulation
members follow the Code of Advertising Acceptance
all PAAB approved materials display the PAAB logo
only preclearance service recognized by Health Canada for advertising directed to HCPs
monitors trends in health product advertising and promotion
maintains a collaborative relationship with Health Canada

Question 8

What is Innovative Medicines Canada?

Answer 8

the national association representing Canadas innovative (brand name) pharmaceutical industry
abides by the PAAB Code of Advertising Acceptance

Question 9

What is Ad Standards?

Answer 9

the national not-for-profit advertising self-regulatory body (not just for prescription medications)

Question 10

Describe Ad Standards.

Answer 10

as Canadas advertising self-regulatory body, Ad Standards administers the Canadian Code of Advertising in Standards
clearance services provide a review mechanism for advertising in five regulated categories:
-children, food and non-alcoholic beverage, alcoholic beverage, health products, cosmetics, and advertising of food to children
works closely with the pharmaceutical industry and Health Canada

Question 11

How does Health Canada try to recognize the importance of the pharmaceutical industry to the general public?

Answer 11

Health Canada clarifies the distinction between advertising to promote the sale of a drug and activities that are not primarily intended to promote the sale of a drug

Question 12

As per the Food and Drugs Act, what is advertising?

Answer 12

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

Question 13

Describe prior to market authorization.

Answer 13

promotion of a drug prior to market authorization (Notice of Compliance) is not permitted because the terms of such authorization have not been established and the proposed indication(s) for use have not been verified/approved

Question 14

After market authorization, what kind of drug information can be disseminated to the general public?

Answer 14

name
price
quantity

Question 15

What are the types of advertising?

Answer 15

reminded branded messages
help seeking announcements
announcement with non-promotional activity
consumer brochures
1.800 telephone numbers/websites
clinical trial recruitment

Question 16

What are reminded branded messages?

Answer 16

those that include the name of the brand, are restricted to the name, price and quantity

Question 17

What are help seeking announcements?

Answer 17

announcements that ask patients among the general public having a particular medical disorder, or that experience a given set of symptoms, to consult a physician or other HCP for discussion of treatment or to call a phone #

Question 18

What are examples of announcements that may be a non-promotional activity for help seeking announcements?

Answer 18

no specific drug is identified
there is no implication that a drug is the sole treatment available for the disease or condition
no drug manufacturer name is included

Question 19

What are consumer brochures?

Answer 19

leaflets/brochures that may make reference to but do not accompany a drug product, and are made available directly or indirectly to the consumer by a drug manufacturer

Question 20

What makes a consumer brochure non-promotional?

Answer 20

the content is disease related
the various treatment options and their respective risks and benefits are discussed in an objective manner
no emphasis is placed on one drug product
no reference is made to an unauthorized drug beyond the mention that research is underway in a particular area’
no reference is made to the availability of unauthorized drugs through the Special Access Programme

Question 21

Describe advertising through 1.800 telephone numbers/websites.

Answer 21

information provided by the sponsor to a member of the general public in response to a call placed to a 1.800 line or via a website set out in a help-seeking announcement may be a non-promotional activity if:
-the content is disease related
-the various tx options and their risks and benefits are discussed
-no emphasis is placed on one drug product

Question 22

What is a clinical trial recruitment?

Answer 22

an announcement that is intended to assist in the recruitment of patients or clinical investigators for a clinical trial may be non-promotional if:
-intent is identified as being for recruitment
-indicates the patient profile is required
-includes a telephone #, email address and/or website for further obtaining information
-no reference is made to the drug manufacturer name or to the drug under investigation

Question 23

How would vaccination campaigns not qualify as advertising of a health product?

Answer 23

public health messages that do not promote a specific product

Question 24

What are the general guiding principles of advertising vaccines?

Answer 24

in accordance with principles set out by Health Canada
accurate, truthful, objective and balance information on the benefits and risks
emphasizing only positive findings is not acceptable
risks and benefits should be noticeable for an average person to read and comprehend

Question 25

How can compliance to the general principles of advertising vaccines be accomplished?

Answer 25

information about the indications, benefits, most common and serious side effects, allergic reactions, important precautions and warnings, contraindications
information related to protection offered by the vaccine
indication of the preventative role of vaccines as opposed to treatment
an explanation that not everyone may be fully protected by the vaccine

Question 26

Are vaccines listed under the Prescription Drug List?

Answer 26

no
listed under Schedule D (biologics)
because the section relating to prohibiting DTCA refers specifically to PDL drugs, vaccines were not subject to the same prohibition as drugs

Question 27

Is it a requirement to submit advertising to Ad Standards for vaccine manufacturers?

Answer 27

no
although encouraged by Health Canada