PAAB for New
  Account Executives &
   Product Managers
                                  Fall 2006




Amanda Strong
aman...
What is PAAB?
• Independent, not-for-profit review
  agency whose primary role is to
  ensure that advertising of
  prescr...
PAAB & Health Canada
• Health Canada is an ex-officio observer and
  advisor “without relinquishing authority
  under the ...
What is an APS?
• PAAB Definition
 – “Any paid message communicated
   by Canadian media with the intent
   to influence t...
It Is Advertising When…
• Contains product reference
  (generally)
• Contains a claim (including
  indication)
• Possesses...
PAAB Exemptions
• PAAB Review exemptions (6.6)
 –   personal solicited correspondence
 –   government agency requirements
...
Can I Use It?

What does PAAB allow as
support for advertising and
promotional messages?
Can I Use It?
• Product Monograph
• Data on File
• Published article
• Reviews, Meta-analyses and
  Guidelines
• Posters, ...
Product Monograph
• Yes!
Data on File
• PAAB 3.1.2
 – Reviewed as part of NDS AND
   evidence of acceptance indicated
   by inclusion in the PM
 – ...
Published Articles
PAAB 3.2.1
 Current literature may be used to
 supplement information contained in
 the product monogra...
Published Articles
• Yes - Publication in a peer-reviewed
  journal (PAAB 3.1.1)
• No - Papers published in journal
  supp...
Published Clinical Trial
• Prospective double-blind,
  randomized, controlled clinical trials
  (RCCT) are best
• Open lab...
Published Clinical Trials
• Primary endpoint must be consistent
  with PM indication
• Formulation must be as per PM and
 ...
Published Clinical Trials
Comparative claims
• Indication in common
• Same conditions of use
  – Equivalent dose ranges
  ...
Published Clinical Trials
• Any data presented in the APS
  must be consistent with the PM
• Data from the results section...
Review Articles
• Generally not very usable
• Can not use data from reviews;
  need to go back to primary
  source
• Can s...
Meta-analyses
• Depends on study design
• Must be rigorously designed
• Drugs included must be approved in Canada
  and in...
Guidelines
• Canadian and current
• Non-Canadian can be used if:
    – No Canadian ones exist
    – To expand upon Canadia...
Guidelines (cont’d)
• Distribution of published guideline as a
  whole document with no promotional
  elements: not be sub...
Posters and Abstracts
• NO!
• Not considered peer-reviewed
  so do not meet PAAB code
Ongoing Studies
PAAB 3.2.4
• Reference to research or ongoing studies
  may be made in a non-promotional context
  with no...
Third Party Pieces
•   NO!
•   Not considered peer-reviewed
    so do not meet PAAB code

    BUT

    I have seen CHE mat...
APS

Mandatory components
of an APS

Absolute “no no”
APS: Mandatories
• Indication
• Contraindications / Warnings /
  Precautions
• Limitations
• Safety / Adverse Events
• Stu...
APS: Mandatories
• Study Parameters (PAAB 5.11)
 –   Design
 –   N- number
 –   Dosage
 –   Comparator
 –   Duration
APS: “No No”
• Superlative claims
• Claims based on laboratory or
  animal reports mixed together
  with human data
• Labo...
APS: “No No”
• Comparisons that attack
  another drug (disparaging)
• Comparisons without p-values
  (or confidence interv...
APS: “No No”
• Hanging comparisons
 –   better
 –   faster acting
 –   improved
• Vague statements
 – compared to the lead...
What’s Changed
• Supplements can not be used
• Data on file must be linked to
  Product Monograph
• All statements in an A...
Educational Pieces

What rules apply to unbranded
APS?

      Note: “branding” also applies to
      brand colours, logos,...
Educational Pieces
•   Same rules apply
•   Context of claim – class vs product
•   Must be consistent with current
    au...
Educational Pieces
• If you combine educational and
  brand messages the message
  becomes “advertising”. (HC policy)
• Mu...
Is It Really Advertising?

The Distinction Between
Advertising and Other Activities
Is it Advertising?
Food and Drugs Act (9.1)
• No person shall label, package, treat,
  process, sell or advertise any drug...
Is It Advertising?
Health Canada Definition
“ any representation by any means
  whatever for the purpose of
  promoting di...
Is It Advertising?
• Health Canada Considerations
  – Context
  – Audience
  – Delivery of message
  – Sponsorship
  – Con...
Unsolicited Requests
• Not considered advertising
• Doctor must contact Med Info
  him or her self
• Rep can not deliver m...
Press Releases
• Directed to shareholders,
  potential shareholders, or media
• No undue emphasis on
  ‘breakthrough’
• Ac...
Press Releases
• Can direct press releases to
  patient advocacy groups and
  media outlets
• Must be fair and balanced
• ...
Rep Activity
• Rx&D 8.2.5
  – Representatives must provide full and
    factual information on products, without
    misre...
Can I do It?
•   Patient Support Literature
•   Patient Information Brochures
•   Consumer Brochure
•   Help Seeking Ads
•...
Patient Support Literature
• Disease versus product related
• Treatment options:
  –   Balanced
  –   Objective
  –   Risk...
Web Site and Telephone
• For consumers
  – Same as patient support or
    consumer brochures depending on
    how hotline ...
Patient Information
• Accompanies a prescription
    – Drug is being prescribed or has been
      prescribed
• Directly pi...
Consumer Brochure
• Disease versus product related
• Treatment options:
  –   Balanced
  –   Objective
  –   Risks AND ben...
Help Seeking Ads
• Okay when:
 – No drug is identified
 – No implication that there is one
   sole treatment available
 – ...
Third Party
• Content must be 100%
  independent of Pharma
• Pharma involvement limited to
  funding development and
  dis...
Service-orientated Items
Service Orientated Items (Rx&D)
 Acceptable service-oriented items are
 defined as items whose pr...
Service-orientated Items
Some service Orientated Item No-No’s
• Agendas, bookmarks, calendars
  (desk top & wall);
• Calen...
Service-orientated Items
Some Service Orientated Item No-No’s
• Stress/rehabilitation balls and similar so-
  called patie...
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PAAB for AEs and PMs

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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.

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PAAB for AEs and PMs

  1. 1. PAAB for New Account Executives & Product Managers Fall 2006 Amanda Strong amanda@medicalcommunications.ca www.medicalcommunications.ca 514.239.2736
  2. 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. 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. 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. 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. 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. 7. Can I Use It? What does PAAB allow as support for advertising and promotional messages?
  8. 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. 9. Product Monograph • Yes!
  10. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 21. Posters and Abstracts • NO! • Not considered peer-reviewed so do not meet PAAB code
  22. 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. 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. 24. APS Mandatory components of an APS Absolute “no no”
  25. 25. APS: Mandatories • Indication • Contraindications / Warnings / Precautions • Limitations • Safety / Adverse Events • Study Parameters (5.11) • Reference to negative findings (3.5.1)
  26. 26. APS: Mandatories • Study Parameters (PAAB 5.11) – Design – N- number – Dosage – Comparator – Duration
  27. 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. 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. 29. APS: “No No” • Hanging comparisons – better – faster acting – improved • Vague statements – compared to the leading brand.... – “Proven track record” (based on what?)
  30. 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. 31. Educational Pieces What rules apply to unbranded APS? Note: “branding” also applies to brand colours, logos, look, etc…
  32. 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. 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. 34. Is It Really Advertising? The Distinction Between Advertising and Other Activities
  35. 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. 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. 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. 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. 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. 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. 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. 42. Can I do It? • Patient Support Literature • Patient Information Brochures • Consumer Brochure • Help Seeking Ads • Third Party Pieces • Service Orientated Items
  43. 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. 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. 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. 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. 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. 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. 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. 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. 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)

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