This presentation gives an overview of what is acceptable in Canadian pharmaceutical advertising to healthcare professionals. It was used to introduce new Account Executives to working with the PAAB code (Fall 2006). It does not reflect more recent changes to the code.

1. PAAB for New
Account Executives &
Product Managers
Fall 2006
Amanda Strong
amanda@medicalcommunications.ca
www.medicalcommunications.ca
514.239.2736

2. What is PAAB?
• Independent, not-for-profit review
agency whose primary role is to
ensure that advertising of
prescription drugs is accurate,
balanced and evidence-based
• Self-regulation through operation of a
preclearance review mechanism in
co-operation with industry, HC
professionals, media, consumers,
government
(Source AMWA PAAB Workshop 2006)

3. PAAB & Health Canada
• Health Canada is an ex-officio observer and
advisor “without relinquishing authority
under the Food and Drugs Act”
• PAAB Commissioner works with Manager,
Advertising and Risk Communications
Section, Marketed Health Products
Directorate at health Canada
• Bi-annual meetings
(Source AMWA PAAB Workshop 2006)

4. What is an APS?
• PAAB Definition
– “Any paid message communicated
by Canadian media with the intent
to influence the choice, opinion or
behaviour of those addressed by
commercial messages”
– “direct or indirect promotion”

5. It Is Advertising When…
• Contains product reference
(generally)
• Contains a claim (including
indication)
• Possesses intent to increase sales
• Draws undue attention to a product

6. PAAB Exemptions
• PAAB Review exemptions (6.6)
– personal solicited correspondence
– government agency requirements
– price lists (no claims)
– institutional messages with no product
– “patient information” direct to patients
– independent educational materials (no
emphasis on sponsor’s drugs, see Health
Canada guideline)

7. Can I Use It?
What does PAAB allow as
support for advertising and
promotional messages?

8. Can I Use It?
• Product Monograph
• Data on File
• Published article
• Reviews, Meta-analyses and
Guidelines
• Posters, Abstracts, Unpublished
Trials, and Third Party Pieces

9. Product Monograph
• Yes!

10. Data on File
• PAAB 3.1.2
– Reviewed as part of NDS AND
evidence of acceptance indicated
by inclusion in the PM
– Citation in bibliography of PM does
not indicate proof of acceptance

11. Published Articles
PAAB 3.2.1
Current literature may be used to
supplement information contained in
the product monograph or provide
further verification of relevant
information in the product
monograph.

12. Published Articles
• Yes - Publication in a peer-reviewed
journal (PAAB 3.1.1)
• No - Papers published in journal
supplements unless the advertiser
can demonstrate that the supplement
has also been subject to a rigorous
peer-review process similar to the
attached journal (PAAB 3.1.2)

13. Published Clinical Trial
• Prospective double-blind,
randomized, controlled clinical trials
(RCCT) are best
• Open label trials are sometimes
acceptable
• Post hoc analyses and pooled data
are generally not acceptable

14. Published Clinical Trials
• Primary endpoint must be consistent
with PM indication
• Formulation must be as per PM and
the same as used in Canada
• Dose range must be as per PM
• Study must have a control arm of
some sort

15. Published Clinical Trials
Comparative claims
• Indication in common
• Same conditions of use
– Equivalent dose ranges
– Similar population
• Statistical analysis performed as part of
per-protocol analysis
– p-value
– Confidence Interval (CI)
– Other methods may be acceptable

16. Published Clinical Trials
• Any data presented in the APS
must be consistent with the PM
• Data from the results section is
preferred
• Do not infer conclusions (or
extrapolate)

17. Review Articles
• Generally not very usable
• Can not use data from reviews;
need to go back to primary
source
• Can sometimes be used to
support medical thought
• Can not extrapolate from class
to product

18. Meta-analyses
• Depends on study design
• Must be rigorously designed
• Drugs included must be approved in Canada
and in appropriate, comparable dose
ranges
• Many articles that claim to be meta-
analyses are actually systematic reviews
• Systematic reviews are not acceptable
SUBMIT META-ANALYSES TO
PAAB FOR AN OPINION

19. Guidelines
• Canadian and current
• Non-Canadian can be used if:
– No Canadian ones exist
– To expand upon Canadian guidelines
BUT must be consistent with Canadian
guidelines
• Used to present medical thought only
• Can not present data
• Supplements usually okay
• CAUTION: single-sponsor consensus
meetings

20. Guidelines (cont’d)
• Distribution of published guideline as a
whole document with no promotional
elements: not be subject to PAAB
review
• Rep distribution may be “advertising”
depending on content

21. Posters and Abstracts
• NO!
• Not considered peer-reviewed
so do not meet PAAB code

22. Ongoing Studies
PAAB 3.2.4
• Reference to research or ongoing studies
may be made in a non-promotional context
with no prominence on information that
has not been approved by Health Canada.
• A study that has been completed or has
been presented at a medical meeting, and
includes information that is not included in
the Health Canada authorized product
monograph, should not be mentioned in
advertising.

23. Third Party Pieces
• NO!
• Not considered peer-reviewed
so do not meet PAAB code
BUT
I have seen CHE material accepted;
not sure why.

24. APS
Mandatory components
of an APS
Absolute “no no”

25. APS: Mandatories
• Indication
• Contraindications / Warnings /
Precautions
• Limitations
• Safety / Adverse Events
• Study Parameters (5.11)
• Reference to negative findings (3.5.1)

26. APS: Mandatories
• Study Parameters (PAAB 5.11)
– Design
– N- number
– Dosage
– Comparator
– Duration

27. APS: “No No”
• Superlative claims
• Claims based on laboratory or
animal reports mixed together
with human data
• Laboratory or animal data used
to imply clinical significance
• Presentations that distort
original meaning

28. APS: “No No”
• Comparisons that attack
another drug (disparaging)
• Comparisons without p-values
(or confidence intervals; CI)
• References to products and
dosage forms (and ranges) not
approved in Canada

29. APS: “No No”
• Hanging comparisons
– better
– faster acting
– improved
• Vague statements
– compared to the leading brand....
– “Proven track record”
(based on what?)

30. What’s Changed
• Supplements can not be used
• Data on file must be linked to
Product Monograph
• All statements in an APS are
seen as drug claims
• Educational information must be
shown to be accepted medical
opinion

31. Educational Pieces
What rules apply to unbranded
APS?
Note: “branding” also applies to
brand colours, logos, look, etc…

32. Educational Pieces
• Same rules apply
• Context of claim – class vs product
• Must be consistent with current
authoritative medical opinion
– Canadian vs. foreign (s3.2)
– Guidelines are ideal
– Textbook may be acceptable
– Consider publication source (complete,
independence, evidence base)

33. Educational Pieces
• If you combine educational and
brand messages the message
becomes “advertising”. (HC policy)
• Must be balanced (ie, can not
guess who sponsor is)
• Different look than branded
pieces

34. Is It Really Advertising?
The Distinction Between
Advertising and Other Activities

35. Is it Advertising?
Food and Drugs Act (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

36. Is It Advertising?
Health Canada Definition
“ 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 ”
-section 2 of Food Drugs Act

37. Is It Advertising?
• Health Canada Considerations
– Context
– Audience
– Delivery of message
– Sponsorship
– Content
– Frequency of Message
“No one factor in itself will determine
whether or not a particular message is advertising.”

38. Unsolicited Requests
• Not considered advertising
• Doctor must contact Med Info
him or her self
• Rep can not deliver materials
requested
• Med Info can distribute off-label
info if requested

39. Press Releases
• Directed to shareholders,
potential shareholders, or media
• No undue emphasis on
‘breakthrough’
• Accurate reflection of data
• Not paid to be published
• Not subsequently distributed to
physicians or consumers

40. Press Releases
• Can direct press releases to
patient advocacy groups and
media outlets
• Must be fair and balanced
• Can not tote drug as a
breakthrough or similar

41. Rep Activity
• Rx&D 8.2.5
– Representatives must provide full and
factual information on products, without
misrepresentation or exaggeration.
– Representatives’ statements must be
accurate and complete; they should not
be misleading, either directly or by
implication.
– Their assertions must be scientific and
should not vary in any way from the
official product monograph and current
Canadian medical thinking.

42. Can I do It?
• Patient Support Literature
• Patient Information Brochures
• Consumer Brochure
• Help Seeking Ads
• Third Party Pieces
• Service Orientated Items

43. Patient Support Literature
• Disease versus product related
• Treatment options:
– Balanced
– Objective
– Risks AND benefits
• No references to unapproved drugs
• No references to special access
programs

44. Web Site and Telephone
• For consumers
– Same as patient support or
consumer brochures depending on
how hotline is promoted
• For physicians
– Must meet PAAB code
– Can not point to non-Canadian
sites with product data

45. Patient Information
• Accompanies a prescription
– Drug is being prescribed or has been
prescribed
• Directly picked up from Information
for the Patient
– Can expand on this information
– Can not introduce new elements
• NO CLAIMS
• NO references to studies

46. Consumer Brochure
• Disease versus product related
• Treatment options:
– Balanced
– Objective
– Risks AND benefits
• No references to unapproved drugs
• No references to special access
programs

47. Help Seeking Ads
• Okay when:
– No drug is identified
– No implication that there is one
sole treatment available
– No drug manufacturer’s name is
included

48. Third Party
• Content must be 100%
independent of Pharma
• Pharma involvement limited to
funding development and
distribution
• Reps can not distribute
(becomes advertising)

49. Service-orientated Items
Service Orientated Items (Rx&D)
Acceptable service-oriented items are
defined as items whose primary goal is to
enhance the health care professional’s or
patient’s understanding of a condition or
its treatment. Such items may bear the
corporate name and logo of the donor, but
must not bear the name of any medicine.
Rx&D 8.2

50. Service-orientated Items
Some service Orientated Item No-No’s
• Agendas, bookmarks, calendars
(desk top & wall);
• Calendar pads, daybooks, desk clocks;
• Diaries, fridge magnets, kit folders;
• Mouse pads, note pads, Obus Forme back
supports;
• Paperweights, pens & penholders, plastic
portfolios;
• Pocket diaries, Post-it Notes, stirrup
covers;
(Source Rx&D 11.2)

51. Service-orientated Items
Some Service Orientated Item No-No’s
• Stress/rehabilitation balls and similar so-
called patient aids;
• Stationery items, such as patient
appointment cards containing patient
information;
• Product bearing advertising;
• Tote bags (single sponsorship); and
• Bags with a corporate logo (single
sponsorship).
(Source Rx&D 11.2)