PMCQ October 14 2003 Agenda l

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@ PMCQ October 14, 2003

Agenda l l PAAB info Common Review Issues Current Initiatives Trends

PAAB b an independent, not-for-profit review agency whose primary role is to ensure that advertising of prescription drugs is accurate, balanced and evidence-based b part of Canadian self-regulation process in cooperation with industry, professions, media, consumers, government and the Code applies to all pharma companies.

PAAB’s Board of Directors l l l l three pharmaceutical trade associations • Rx&D, CGPA, NDMAC health professionals - CMA, CPh. A, FMSQ Consumers Association of Canada (CAC) Canada’s Assoc for the Fifty-Plus (CARP) Can Assoc of Medical Publishers (CAMP) advertising industry (AMAA, ASC) Chair, Past-Chair, Treasurer

Health Canada is an ex-officio observer and advisor “without relinquishing authority under the Food and Drugs Act” l PAAB Commissioner liaison with Manager, Advertising and Risk Communications Section, Marketed Health Products Directorate • “PAAB and Therapeutic Products Directorate Roles l and Consultation Related to Advertising Review”

Policy - Direct transfer to Health Canada l l Complaints including safety allegations Complaints about Direct-to-Consumer prescription drug advertising Complaints about advertising of unapproved products Noncompliance with PAAB rulings - applies to all companies

Rx&D l A violation of the PAAB Code is a violation of the Rx&D Code l PAAB Commissioner is a voting member of the Marketing Practices Review Committee

DTCRx Message Advisory l l Asked by Health Canada and Rx&D will review Reminder, help-seeking, and consumer brochures related to prescription drug messages broadcast and print use Health Canada guideline as basis for the review

PAAB STAFF l l l Commissioner Deputy Commissioner/Senior Reviewer 5 Reviewers Submission Coordinator Receptionist/Admin Bookkeeper (part-time)

Workload l l In 2002 - there were 3228 first reviews (submissions) over 10, 000 file reviews annually including revisions

Agenda l PAAB info l Common Review Issues

Common Review Issues l l l previously rejected claims fair balance type size (s 2. 4) adequacy of evidence • open-label studies, subpopulation data l l long-term claims not in product monograph use of PM clinical study data indications re concomitant diseases consensus guidelines (brand names) misuse of end-point data (cherrypicking)

Agenda l What is the PAAB? Common Review Issues l Current Initiatives l

PAAB Task Forces - 2003 1. 2. 3. 4. Health Canada relations Review Consistency Communications Plan Stakeholders

PAAB Initiatives l l l Health Canada meeting Legislative Renewal House of Commons Standing Committee on Health - prescription drugs focus PAAB Training Workshop Trustmark Code Revision? (evidence, CME, DTC, fair balance and PI, Internet)

Agenda l What is the PAAB? Common Review Issues Current Initiatives l Trends l l

Trends APS Then and Now l Then - only a few forms of traditional promotion • Now - more creative options & media, complex APS l Then - more distinction between educational and promotional material • Now - looking for or creating “grey” areas l Then - greater restraint by industry with respect to regulations • Now - keen competition pushes the line and there is a need for improved knowledge in science and ethics Conclusion: PAAB is more challenged today

Trends l l l l Consumerism approach in HP advertising pre-NOC marketing activities illegal advertising claims for natural health products “educational” material compliance issues “seeding” trials Internet e-detailing outcome claims from open label studies out-of-control reps

Will it be PAAB or the Feds? Self-regulation vs government regulation

Can we trust the pharmaceutical industry to act in a responsible manner?

Thank You

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