Malika Ladha malikalpaabca PAAB Reviewer Chester Bowles Regulator and member in the 1941 US Wartime Office of Price Administration 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 ID: 812992
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Slide1
The ‘What’ and ‘Who’ of Advertising
Malika Ladha
malikal@paab.ca
PAAB Reviewer
Slide2Chester Bowles
Regulator and member in the 1941 U.S. Wartime Office of Price Administration
“
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
.”
Slide3Self-regulation
CANADA
Government Regulation
Slide4For success
Three critical elements
:
An effective mechanism (preclearance is best)Support from major industry playersSupport and trust from the governmentSelf regulation is like a vaccine that prevents bad things from happening
Slide5Who reviews what?
Health Canada
Food and Drugs Act
PAAB Code
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
ASC/MIJO
C
ontrolled
Advertising
HC/PAAB/ASC
Independent Preclearance Agencies
Slide6Important takeaways
Drug advertising is regulated
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
Slide7What 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”
Slide8Food 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
Slide9The 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 ?
Slide10The 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.
Slide11PAAB
Slide12PAAB Brief History
Incorporated 1976
Government threat to industry
Multi-stakeholder approachUnique modelCode applies to all companiesDynamic codeEvolving organizationBetween Industry and Government
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Slide13PAAB
VISION
Trusted healthcare product communication that promotes optimal health
MISSIONTo provide a preclearance review that fosters trustworthy healthcare communications within the regulatory framework.
VALUES Integrity, Competency, Credibility, Independence, Excellence, Transparency
Slide14MANDATE
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.
Slide15Scope
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 direct-to-consumer materials for prescription drugs. PAAB’s Scope evolves with the regulatory framework.
Slide1616
New PAAB Code was implemented on July 1, 2013
Slide17PAAB Code of Advertising Acceptance
Dynamic, reflects current marketplace
Works in best interest of patients
Requires 2/3 majority vote of members to reviseStandards including:regulatory scientific
clinicalethical principles
Slide18PAAB’s Board of Directors
pharmaceutical trade associations
Rx&D, CGPA, CHPC, BioteCanada
health professionals - CMA, CPhA, FMOQ, AFMCpatients - Best Medicines Coalition (BMC) CARP, Consumers Council of Canada (CCC)Can Assoc of Medical Publishers
(CAMP)advertising industry (AMAA)Chair, Vice-Chair, Treasurer
Slide19Health
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
DirectorateAnnual Bilateral Consultation meetingsPolicy - Roles and Consultation Related to Advertising Review, Health Canada and preclearance agencies
Slide20PAAB preclearance services
PAAB code covers
HCP
AdvertisingPatient Information provided through HCPs PAAB advisory service (using Health Canada policy documents):Consumer InformationConsumer 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
Slide21PAAB Code section 6.6
Exemptions from PAAB review
PAAB code 6.6(iv
): Use of drug name only in a context not linkedto 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
Slide22Target your message to match your audience
Slide23Three 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.
Slide24APS directed towardsPATIENTS
Slide25PAAB 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.
Slide26Thought 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?
Is the piece non-promotional?
Is risk information from Part III of the Product Monograph required?
26
Slide27Standard 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 personA commercial website
Controlled by pharma
27
Slide28Standard 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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Slide29Questions?