Transcript `What` and `Who` of Advertising

The ‘What’ and ‘Who’ of Advertising
Malika Ladha
[email protected]
PAAB Reviewer
Chester Bowles
“20% of the regulated
population will
automatically comply with
any regulation, 5% will
attempt to evade it, and 75%
will comply so long as they
think the 5% will be caught
and punished.”
Regulator and member in the 1941 U.S. Wartime Office of Price Administration
CANADA
Self-regulation
Government Regulation
For success
Three critical elements:
• An effective mechanism (preclearance is best)
• Support from major industry players
• Support and trust from the government
Self regulation is like a vaccine that prevents bad
things from happening
Who reviews what?
Food and Drugs Act
Health
Canada
Policies, Guidelines & Regulations on
Drug Advertising
Rx and non-Rx drug
advertising to HCP
Non-Rx drug advertising
to General Public
Rx drug advertising
To General Public
Independent Preclearance Agencies
PAAB Code
ASC/MIJO
Controlled
Advertising
HC/PAAB/ASC
Important takeaways
Drug advertising is regulated
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No person shall ... advertise a new drug unless…the Minister has issued a Notice of
Compliance to the manufacturer of the new drug… (FDA c.08.002)
•
No person shall ... advertise any drug in a manner that is false, misleading or deceptive
or is likely to create an erroneous impression regarding its character, value, quantity,
composition, merit or safety. (section 9.(1))
Self-regulation is a privilege, not a right
Industry’s actions must be aligned with the
regulations to promote credibility and trust through
improvement of patient care
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”
Food and Drugs Act Section 9(1)
No person shall label, package, treat, process,
sell or advertise any drug in a manner that is
false, misleading or deceptive or is likely to
create an erroneous impression regarding its
composition, merit or safety
The 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 ?
The Distinction Between Advertising
and Other Activities:
“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.
PAAB
PAAB Brief History
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Incorporated 1976
Government threat to industry
Multi-stakeholder approach
Unique model
Code applies to all companies
Dynamic code
Evolving organization
Between Industry and Government
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PAAB
VISION
–
Trusted healthcare product communication that promotes optimal health
MISSION
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To provide a preclearance review that fosters trustworthy healthcare
communications within the regulatory framework.
VALUES
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Integrity, Competency, Credibility, Independence, Excellence,
Transparency
MANDATE
• The PAAB is an independent review agency whose
primary role is to ensure that healthcare product
communication for prescription, non-prescription,
biological and natural health products is accurate,
balanced and evidence-based, and reflects
current and best practice.
• The PAAB also monitors trends in health product
advertising and promotion and adjusts its code
and practices as required to fulfill its mandate.
Scope
• The scope of the PAAB includes promotional
healthcare product communication for
prescription, non-prescription, biological and
natural health products to health care
professionals in all media.
• PAAB also provides advisory comments on directto-consumer materials for prescription drugs.
PAAB’s Scope evolves with the regulatory
framework.
New PAAB Code was
implemented on July 1,
2013
PAAB Code of Advertising Acceptance
• Dynamic, reflects current marketplace
• Works in best interest of patients
• Requires 2/3 majority vote of members to revise
• Standards including:
– regulatory
– scientific
– clinical
– ethical principles
PAAB’s Board of Directors
• pharmaceutical trade associations
– Rx&D, CGPA, CHPC, BioteCanada
• health professionals - CMA, CPhA, FMOQ, AFMC
• patients - Best Medicines Coalition (BMC)
CARP, Consumers Council of Canada (CCC)
• Can Assoc of Medical Publishers (CAMP)
• advertising industry (AMAA)
• Chair, Vice-Chair, Treasurer
• Health Canada is an ex-officio observer and advisor “without relinquishing
authority under the Food and Drugs Act”
• PAAB Commissioner liaison with Manager, Advertising and Risk
Communications Section, Marketed Health Products Directorate
• Annual Bilateral Consultation meetings
• Policy - Roles and Consultation Related to Advertising Review, Health Canada
and preclearance agencies
PAAB preclearance services
PAAB code covers
• HCP Advertising
• 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
PAAB Code section 6.6
 Exemptions from PAAB review
PAAB code 6.6(iv): Use of drug name only in a context not linked
to therapeutic or promotional messages, other than those listed below, in
any way.
Examples:
– Company price lists containing no therapeutic claims, price
comparisons or claims of company or product merit, status or issues
– Message comprised only of the words “now on provincial formulary”
(or equivalent) in a manner which is not linked to a therapeutic
message in any way
– Message of “Available at company X”
– A message of “Congratulations to company X on their 30th anniversary
– sponsored by Company X makers of product Y”
– Packshots if no therapeutic claims are visible
Target your message to match your audience
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.
APS directed towards
PATIENTS
PAAB Code section 6.4.3
Information that is:
• Non-promotional
• Consistent with the consumer information
section of the Product Monograph
The information should focus on educating patients
about particular diseases/conditions and optimal
use of the product by the patient for whom it has
been prescribed.
Thought Process Sequence
Is the piece only about the specific product which was prescribed?

Is the drug content consistent with Part III of the Product
Monograph?
AND
Is the disease content on label and supported by standard setting
organizations or authoritative sources?
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Is the piece non-promotional?

Is risk information from Part III of the Product Monograph
required?
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Standard Setting Organizations
What they are:
• Group generally considered to be a credible source for patient
information
• Package complex medical information in a manner which is
easy for patients to understand
What they aren't:
• A person
• A commercial website
• Controlled by pharma
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Standard Setting Organizations
Examples:
• Patient groups (e.g., the Asthma Society of Canada)
• Medical institutions (e.g., a hospital)
• Health care professional organizations (e.g.,
Canadian Nurses Association)
• Consensus groups (e.g., Canadian Diabetes Association)
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Questions?