@ PMCQ October 14, 2003

Agenda l PAAB info l Common Review Issues l Current Initiatives l 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 co-operation with industry, professions, media, consumers, government and the Code applies to all pharma companies.

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

l 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 and Consultation Related to Advertising Review”

Policy - Direct transfer to Health Canada l Complaints including safety allegations l Complaints about Direct-to-Consumer prescription drug advertising l Complaints about advertising of unapproved products l 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 Asked by Health Canada and Rx&D l will review Reminder, help-seeking, and consumer brochures related to prescription drug messages l broadcast and print l use Health Canada guideline as basis for the review

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

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

Agenda l PAAB info l Common Review Issues

Common Review Issues l previously rejected claims l fair balance type size (s2.4) l adequacy of evidence open-label studies, subpopulation data l long-term claims not in product monograph l use of PM clinical study data l indications re concomitant diseases l consensus guidelines (brand names) l misuse of end-point data (cherrypicking)

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

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

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

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

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