Agmrept99_2.pdf

Pharmaceutical Advertising Advisory Board October 1999
November General Meeting
The next PAAB General Meeting of Directors will be ACTIVITIES DURING THE
held Friday November 5, 1999 at the College of THIRD QUARTER OF 1999
Family Physicians in Mississauga, Ontario from 9a.m. to 1 p.m.
Ad hoc DTC Committee formed
Code Clarification Bulletins
At the June 22 1999 Executive Committee meeting,Dr. Reg Perkin created a sub-committee to analyze In early October, 2400 Canadian drug marketers PAAB’s operational readiness to handle Direct-to- received two bulletins from PAAB. One clarified Consumer prescription advertising and to make the Code section 7 requirement for prescribing recommendations to the Board. David Skinner information to accompany direct mail (including (NDMAC) was appointed Chair and the members Fax) advertising. The other guideline clarified the are Jean Jones. (CAC), Edward Stapor (AMAA), Dr.
application of the Code section 6.6a re educational Perkin, Faheem Hasnain (Rx&D Canada) and material exemptions from PAAB review. The Commissioner Ray Chepesiuk. The first meeting clarification bulletins were distributed because the was held September 8 and it is expected that the PAAB staff noticed a rise in Code infractions in Committee will make recommendations to the Board at the November General Meeting.
Review Activity
New Reviewer Hired
During the period of July 1 to September 30 1999,the total number of submissions reviewed was 683.
This compared to 592 during the same period of announce that PAAB has hired a new AssistantCommissioner/Reviewer, Ms. Yin-Ling Man,effective September 7, 1999. Yin-Ling is a graduateof the University of Toronto and has been a The proportion of advertising vehicles that were practicing hospital and community pharmacist in submitted for review shows a workload oriented Toronto. She becomes the fifth reviewer in thecurrent PAAB staff. PAAB had been handling theincreased 1999 volume with four reviewers, one less than the staff complement during most of 1998.
Yin-Ling will be trained under the supervision ofSenior Reviewer Jane Shum.
towards detail and direct mail activity.
2 PAAB JULY 1999 UPDATE
In 1999, the total number of submissions reviewedyear-to-date was 2040, an 18% increase comparedto the 1998 total of 1721.
PAAB COMPLAINT REPORT
Period: July 1, 1999 to September 30, 1999
During the third quarter of 1999, 91% of thesubmissions were given a first review response infive days or less and 100% were given a review During the period of July 1 to September 30 1999, the PAAB Commissioner processed 8 Stage 2 complaints.
This number brings the total for 1999 to 17. PAAB
For year to date, 96%% were reviewed in 5 days or reviewed 682 advertising pieces during the months of July, August and September 1999 and the year-to-datetotal is 2040.
Of the 8 complaints, 4 were generated from advertising Share of ads reviewed in 1- 5 days
that had been previously PAAB-reviewed with two havingthe same advertising as the subject. All 4 of thesecomplaints resulted in withdrawal of PAAB’s previous acceptance. One of these complaints was sent to PAAB by a group of health professionals. The 4 complaints on advertising that were not PAAB-approved were sustained.
Two were sent to PAAB by health professionals. One of those complaints was sent to Health Canada for actionbecause it related to a product that had not received PAAB has continued to regularly monitor journals, the
Internet, and receive direct-mail/detail aid materials
collected by health professionals as part of its monitoring
program. During the third quarter of 1999, a total of 5
monitoring letters were sent for 2 unreviewed pieces
COMPLAINTS AND MONITORING
containing misleading and/or off-label claims and 3expired ads. This brings the total for this year to 19. All of the ads were either withdrawn or resubmitted for PAAB Complaints against Advertising/Promotion Systems (APS) review. Two cases were referred to their respective trade may be lodged by: health professionals, health care association for appropriate action while in one case organizations, pharmaceutical companies, federal and Health Canada was informed of the infraction.
provincial regulatory bodies and drug payer organizations. Code Section 9 contains a guide for the resolution ofcomplaints against pharmaceutical advertising that is STAGE TWO DECISIONS
subject to review by the PAAB. Organizations areencouraged to act in the spirit of the Code to seekresolution and abide by those terms, even in specific situations which are not directly anticipated in section 9. ADVERTISER:
There are three different levels of PAAB administrative
response. In Stage ONE, the complaint is sent directly to
COMPLAINANT: Bristol-Myers Squibb & Sanofi
the advertiser by the complainant or to the advertiser viathe PAAB Commissioner. The advertisers responds in SUBJECT: c99-18 Atacand (candesartan) PAAB-approved
writing to the complainant. The complainant then has Detail Aid and Journal Ad approved in 1998. See also #3 re three options: continue discussion with the advertiser, possibly by writing another letter narrowing the points ofdispute; accept the advertiser’s response; or conclude PRECLEARANCE:
that further intercompany dialogue will not be productiveand therefore seek review by the PAAB Commissioner in ALLEGATIONS: multiple allegations citing 21 Code sections.
Stage TWO. Either the complainant or advertiser has
Two allegations were sustained . These two were similar to the the right to appeal the Commissioner’s reassessment two allegations sustained in the complaint ruling on Atacand ruling to a Stage Three independent Review Panel made
up of three qualified individuals selected by theCommissioner from individuals named by national PAAB DECISION: Sustained part of allegations, rejected
others. Violation of section 3.1; although AstraZeneca arguesthat showing the 32 mg dose was necessary to prove dose- 3 PAAB JULY 1999 UPDATE
response, promotion of the 32 mg dose is not accepted because it is not an approved dose within the Health Canada acceptedProduct Monograph. Violation of section 5.2 which came into OUTCOME: Eli Lilly agreed with the PAAB ruling and met
effect January 1999; comparison of Atacand 16 mg versus with PAAB to discuss revision. Eli Lilly chose not to advertise Cozaar 50 mg and related superiority claims is an unfair by journal ad during the remainder of 1999 and the detail aid comparison of non-equivalent doses. The other allegations was revised during the month of August 1999.
were rejected because they were subjective in nature and didnot have substantive merit.
PENALTY: AstraZeneca had already responded to the
ADVERTISER: AstraZeneca
previous ruling on c99-28 and had discontinued distribution ofthe offensive materials. New material had been created to COMPLAINANT: Merck-Frosst
replace the violative material. Therefore, no additional penaltywas assessed.
SUBJECT: c99-28 Atacand (candesartan) PAAB-approved
Detail Aids approved in 1998. See also #1 re c99-18.
OUTCOME: AstraZeneca complied with ruling and revised
their advertising material. PAAB reviewers were informed of
PRECLEARANCE:
ALLEGATIONS: Promotion of 32 mg dose that is not
consistent with the Product Monograph. Unfair comparison
of Atacand 16 mg to Cozaar 50 mg, (s5.2).
ADVERTISER: Eli Lilly
PAAB DECISION: Violation of section 3.1; although
COMPLAINANT: 3 Health Professionals at British Columbia
AstraZeneca argues that showing the 32 mg dose was Ministry of Health and University of British Columbia.
necessary to prove dose-response, promotion of the 32 mgdose is not accepted because it is not an approved dose within SUBJECT: c99-24 Evista (raloxifene) Journal ad, PAAB-
the Health Canada accepted Product Monograph. Violation of section 5.2 which came into effect January 1999; comparisonof Atacand 16 mg versus Cozaar 50 mg and related superiority PRECLEARANCE:
claims constitute an unfair comparison of non-equivalentdoses.
ALLEGATIONS: Allegations related to improper prescribing
information, promotion of unapproved indications, misleading
PENALTY: Discontinuation of both detail aids.
claims, and omission of clinically significant risk information.
OUTCOME: AstraZeneca agreed with the PAAB decision.
PAAB DECISION: Sustained part of complaint allegations,
rejected others. There appeared to be infractions of Code
sections 2.1 and 3.1. With respect to the copy and graphics,
PAAB agreed with the complainant that the context of the ad, ADVERTISER: AstraZeneca
i.e. position of copy and graphics, use of small type sizefootnotes for safety information, was found to be misleading COMPLAINANT: Abbott
because it did not appropriately reflect the spirit and contextof the related claims in the product monograph. There is a SUBJECT: c99-33 Losec journal ads
perception of promotion of unapproved indications under ageneral headline stating “woman’s health” as opposed to PRECLEARANCE:
“osteoporosis”. Wording related to “choice” was ambiguousand could give the impression that Evista was “the first ALLEGATIONS: Abbott states that AstraZeneca
choice” (code section 5.15). A safety claim related to venous “knowingly and willingly” omitted prescribing information thromboembolic events should be conveyed in advertising. To from journal ads to save money and gain a competitive address Code section 4.2 absolute values should accompany relative risk values to clarify the meaning. The allegationsabout improper prescribing information were rejected. PAAB PAAB DECISION: Upon investigation, it was learned that
advised Eli Lilly that a Detail Aid containing a similar context the advertising agency for AstraZeneca took responsibility for the omission. Early insertions were accompanied byPrescribing Information and another ad with multiple claims.
The agency thought the minor claim structure of the journal ad PENALTY: Eli Lilly was ordered to discontinue future
warranted Reminder Disclosure after the multiple claim ad insertions of the journal ad and destroy the current detail aid.
stopped running. PAAB had approved the ad to run with PAAB would work with Eli Lilly to expedite revised material 4 PAAB JULY 1999 UPDATE
prescribing information. PAAB could find no evidence that PAAB DECISION: Commissioner rules that claim is
AstraZeneca willfully propagated this action to gain a premature because the short term methodology of the support study does not support an absolute claim of “end bedwetting”.
Ad should be revised. Also, there is an infraction of PENALTY: AstraZeneca to include prescribing information
advertising without current PAAB clearance.
and consult PAAB in future regarding reminder disclosurerequirements.
PENALTY: Discontinue ad immediately and revise claims
for a new ad.
OUTCOME: AstraZeneca agreed with the PAAB decision.
OUTCOME: Ferring agrees with PAAB decision.
ADVERTISER: Glaxo Wellcome
ADVERTISER:
COMPLAINANT: Hoechst Marion Roussel
COMPLAINANT: Health professional in Winnipeg and
referred by Rx & D Canada.
SUBJECT: c99-35 Zyban (bupropion) PAAB-approved
journal ad.
SUBJECT: c99-41 multi-product Diffusimax mailer
PRECLEARANCE: Yes
PRECLEARANCE:
ALLEGATIONS: There is misleading wording on a
ALLEGATIONS: Promotion of products prior to obtaining
comparative claim in that the specific comparative agent was Notice of Compliance from Health Canada.
not stated in body copy, but only in a footnote. The claim“compared to the patch” implied a broader comparison that PAAB DECISION: In accordance with bi-partite agreement
about off-label claims (pre-NOC advertising), this complaintwas forwarded to Health Canada for action.
PAAB DECISION: Although not grossly misleading, the ad
should be revised to state the comparative agent in a clear
PENALTY: Awaits Health Canada decision.
manner to meet the current requirements of Code sections 2.1and 5.5.
OUTCOME: Awaits Health Canada decision.
PENALTY: Withdrawal of PAAB acceptance and creation
of a new journal ad.
8.
ADVERTISER: Hoechst Marion Roussel
OUTCOME: Glaxo Wellcome agreed with the PAAB
decision.
COMPLAINANT: Pfizer Canada
SUBJECT: c99-41 Allegra (fexofenadine) detail brochure
6.
ADVERTISER:
PRECLEARANCE: No
COMPLAINANT: c99-38 - Health professional at
ALLEGATIONS: The context of the graphic depicting a
Dalhousie University and forwarded by Health Canada sleeping person beside first generation antihistamines andReactine (cetirizine) was an unfair attack (s5.6).
SUBJECT: Non-PAAB approved Journal ad with PAAB
Clearance having expired in January 1998.
PAAB DECISION: The brochure was similar in content to a
brochure approved by PAAB. However, a graphic depicting a
PRECLEARANCE: No ( Expired January 1998)
sleeping person was added to two places and this was notbrought to the attention of PAAB. The Commissioner ruled ALLEGATIONS: Alleges wording “end bedwetting” is not
that the graphic comparison was an unfair attack because the supported by the listed reference i.e. there is no support for a comparative claim contradicted the the Health Canada claim of long term or absolute end to bedwetting. Company approved product monograph for Reactine.
responds that more data will appear from ongoing trials tosupport the claim.
PENALTY:
1. HMR to immediately discontinue distribution and
5 PAAB JULY 1999 UPDATE
2. HMR to recall and destroy all distributed brochures.
3. HMR to send letter to pharmacists to explain the recall of PAAB is an independent review agency whose primaryrole is to ensure that advertising of prescription drugs is OUTCOME: HMR agreed to carry out the prescribed action
accurate, balanced and evidence-based. The scope of the PAAB Code currently includes advertising ofprescription and OTC products to health professionals, inall media. • Maintaining the Code of Advertising Acceptance, which is approved by representatives of member Commissioner: Ray Chepesiuk
Senior Reviewer: Jane Shum
Preclearing advertising prior to publication, to ensure Reviewers/Assistant Commissioners:
claims meet Code standards. The scope of the Code currently includes advertising of prescription and OTC drug products to health professionals, in all media. PAAB also reviews veterinary medicine journal advertising using separate guidelines Submission Co-ordinator:
• Training, adjudicating complaints, administering penalties, reporting of infractions, and other activities Admin Support: Estelle Parkin
Accounts:
All can be reached at (905) 509-2275. For information or if you have comments: Pharmaceutical Advertising Advisory Board375 Kingston Road, Suite 200Pickering, Ont. L1V 1A3Tel: (905) 509-2275 fax: (905) 509-2486 Who makes up the “Board” in PAAB? The PAAB Code of Advertising Acceptance and PAAB Voting Organizations
Supplementary Guidelines are available from the PAABoffice or at www.paab.ca Advertising Standards CanadaAssociation des médecins de langue française duCanada You can find these key Health Canada documents at Association of Medical Advertising Agencies http://www.hc-sc.gc.ca/hpb- dgps/therapeut/htmleng Canada’s Research-Based Pharmaceutical Companies Canadian Association of Medical PublishersCanadian Drug Manufacturers Association • Distinction of Advertising and Other Activities Canadian Pharmacists AssociationConsumers’ Association of Canada • PAAB and Drugs Directorate Roles and Consultation Nonprescription Drug Manufacturers Association Voting Individuals
Treasurer
Commissioner Ray Chepesiuk
Executive Committee
Vice-Chair

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