Direct-to-consumer advertising & prescription drug promotion Report

Table of contents:

1. The Worldwide Pharmaceutical Market & Prescription Drug Promotion

• Introducing Drug Promotion & Advertising
• Recent Trends in Prescription Brands Promotion & DTC Advertising
• The Objectives of this Report
• Questions to be Answered in this Report

2. The Value of the Worldwide & Regional Pharmaceutical Markets

• Table 1. The Value of the Worldwide Pharmaceutical Market by Drug Purchases in the 12 months to July 2002
• Graph 1. Value of Regional Pharmaceutical Markets by Retail Purchases in the 12 months to July 2002
• Table 2. Leading Therapeutic Categories by Worldwide Drug Purchases through Retail Pharmacies
• Graph 2. Leading Therapeutic Categories in the Worldwide Pharmaceutical Market
• Table 3. Regional Pharmaceutical Market Values by Drug Purchases in the 12 Months to July 2002
• Graph 3. Leading Therapeutic Classes in the North American Pharmaceutical Market
• Graph 4. Leading Therapeutic Classes in the European Pharmaceutical Market
• Graph 5. Leading Therapeutic Classes in the Japanese Pharmaceutical Market

3. The Regulation of DTC Advertising of Prescription Drugs in the U.S

• 3.1 Differentiating between Over-the-Counter (OTC) Products & Prescription Therapeutics
• 3.2 Promotion & Marketing of Prescription Drugs
• 3.3 Regulatory Guidelines & DTC Advertising
  • 3.3.1 The Federal Food, Drug & Cosmetic Act in the U.S
  • 3.3.2 Regulations that Dictate the eWordingi of Advertisements
  • 3.3.4 Reminder Advertisements & Labeling
• 3.4 Broadcast Vs Print Advertisements: Regulations Specifying Information in Broadcast Adverts
  • Box 1. FDA Guidance for Rx Drug Advertisements
  • 3.4.1 Two Key Regulatory Requirements for Broadcast Adverts
  • Table 4. Summary of FDA Guidelines on DTC advertising of Prescription Drugs in the U.S. Marketplace
• 3.5 The Role of the Federal Trade Commission

4. The Marketing & Promotion of Prescription Drugs in the U.S

• 4.1 Recent Trends in Pharmaceutical Advertising Expenditure in the U.S. Marketplace
  • Table 5. Current & Forecast Advertising Expenditure in the U.S. Pharmaceutical Marketplace
  • Graph 6. Current & Forecast Pharmaceutical Advertising Expenditure in the U.S
  • Table 6. Projected Pharmaceutical Advertising Expenditure in the U.S. (DTC & Professional)
  • Graph 7. Projected Advertising Expenditure in the U.S. Pharmaceutical Market
• 4.2 Pharmaceutical Promotion Channels
  • Table 7. Promotional Spending by Channel (1998 - 2001)
  • Graph 8. Pharmaceutical Promotional Expenditure by Channel
  • Table 8. Total Promotional Expenditure (1998-2001)
  • Graph 9. Trends in Total Pharmaceutical Promotional Expenditure
  • Graph 10. Percentage Year-on-Year Increase in Total Promotional Spending
• 4.3 The Promotion of Prescription Drugs to Healthcare Professionals & Consumers
  • 4.3.1 Emerging Market of DTC Advertising of Prescription Drugs
  • Box 2. American Medical Association (AMA) Guidelines on DTC Advertising of Prescription Therapeutics
  • 4.3.2 The Promotion of Prescription Drugs to Healthcare Professionals
  • Table 9. Pharma Spending on DTC Advertising & Promotion to Healthcare Professionals
  • Graph 11. Trends in Promotional Spending on DTC Advertising (1996-2000)
  • Graph 12. Total Promotional Spending on DTC Advertising (1996-2000)
  • Graph 13. Trends in Promotional Spending to Healthcare Professionals
  • Graph 14. Total Promotional Spending to Healthcare Professionals
  • Table 10. Total Promotional Spending on DTC Advertising & Promotion to Healthcare Professionals
  • Graph 15. Total Promotional Spending (DTC Advertising & Promotion to Healthcare Professionals)
  • Graph 16. Recent Trends in Total Promotional Spending as a Percentage of Sales (1996-2000)
• 4.4 Analysis of Recent Trends in Pharmaceutical Spending on Drug Advertising & Promotion
  • 4.4.1 Television Vs. Print Advertising
  • 4.4.2 Professional Vs. DTC Advertising
  • 4.4.3 Trends in Total Prescription Drug Promotional Expenditure
• 4.5 Variations in Marketing Strategies for DTC Advertising & Healthcare Promotion
• 4.6 Key Media Channels for the Promotion of Brand Name Prescription Drugs in 2001
  • Table 11. Promotional Expenditure by Media (2000-2001)
  • Graph 17. Key Media Channels for the Promotion of Prescription Drugs in 2001
• 4.7 Trends in DTC Advertising of Prescription Drugs
  • Graph 18. % Increase in DTC Advertising Spending Year-on-Year from 1996 to 2000
  • Table 12. % Year-on-Year Growth in DTC Advertising Expenditure (1996-2000)
• 4.8 Factors Contributing to the Recent Slowdown in Pharmaceutical Expenditure on DTC Advertising

5. E-Marketing Prescription Drugs using the Internet & Emerging Technologies

• 5.1 Advertising Challenges for Internet promotion of Prescription Drugs to Consumers
• 5.2 iGreyi Areas in FDA Guidelines for DTC Advertising of Prescription Drugs in Cyberspace
• 5.3 FDA Enforcement of DTC Advertising Guidelines
  • Box 3. Internet Advertising Issues Highlighted in FTC Guidelines
• 5.4 Prescription Drug Advertising Issues Specific to the Internet
  • 5.4.1 Amount of Information Presented in an Advert & the Content of Prescription Drug Promotional Materials on the Internet
  • 5.4.2 The Lack of Manufacturer Control over Website Access
  • 5.4.3 Websites Supplementing Broadcast Advertisements
  • 5.4.4 How Should Banner Advertisements be Regulated?
  • 5.4.5 Hyperlinks to Websites containing Unapproved Indications for an Advertised Prescription Drug
  • 5.4.6 Policing Prescription Drug Promotion & Drug Dispensers on the Internet
• 5.5 Monitoring Websites & Internet Drug Promotion
  • Box 4. Internet advertising of pharmaceuticals products & factors that violates U.S. law:
• 5.6 Future of Internet Advertising & FDA Guidelines
  • Figure 1. Regulatory Guidelines that Affect Prescription Drug Promotion
• 5.7 Internet Advertising & Healthcare
  • Graph 19. Projected Market Value of Online Drug Sales by 2005
• 5.8 E-Detailing of Prescription Drugs to Physicians
  • 5.8.1 What is E-Detailing?
  • 5.8.2 The Emerging Strategy of E-Detailing for the Promotion of Prescription Drugs to Medical Professionals
  • Box 5. Potential Disadvantages of E-Detailing Pharmaceutical Products
  • 5.8.3 Factors Driving the Growth of E-Detailing in the U.S. Market
  • Box 6. The Benefits of E-Detailing to Healthcare Professionals & Pharmaceutical Companies
  • 5.8.4 The Disadvantages of Static Product Information Websites
  • Table 13. Main Types of E-Detailing Models in the U.S
  • 5.8.5 Differences in E-Detailing Approaches Between U.S. & Europe
  • Box 6. Recent E-Detailing Approaches adopted in the U.S. Pharmaceutical Marketplace
  • 5.8.6 The European Marketplace & E-Detailing Technologies
  • Box 7. U.S. Companies that Supply E-Detailing Products & Tools
• 5.9 The Future of Pharmaceutical E-Detailing & Limitations of Traditional Approaches
  • 5.9.1 Traditional Detailing Approaches & Expanding Sales Forces
  • Table 14. Expanding Sales Forces of Pharmaceutical Companies & the Diminishing Number of U.S. Physician Calls per Extra Drug Sales Representative
  • Graph 20. The Annual Number of Face-to-Face Calls to Physicians from Sales Representatives in the U.S
  • Graph 21. The Diminishing Number of Physician Calls per year & per Sales Representative
  • 5.9.2 The Future of E-Detailing Pharmaceuticals & Advantages over Traditional Detailing Approaches that Rely on Sales Reps
  • Table 15. Benefits of E-Detailing to Physicians Compared with Traditional Detailing Methods

6. The Debate over Prescription Drug Advertising to Consumers

• 6.1 Campaigners Against DTC Advertising
  • Box 8. Key Facts about DTC advertising
• 6.2 Industry Supporters of DTC Advertising
• 6.3 Potential Benefits of Advertising Prescription Drugs to Consumers
• 6.4 The Impact of DTC Advertising
  • Table 16. Annual DTC Advertising Expenditure for Prescription Brands
  • 6.4.1 Which patient groups are more likely to ask about prescription drug costs & what are the effects of DTC advertising?
  • Graph 22. Annual DTC Advertising Expenditure for Brand Name Prescription Drugs
  • ($US billion)
  • Box 9. Facts about Drug Promotion & Average Price of Prescription Brands
  • 6.4.2 Viewpoints on the Impact of Prescription Drug Promotion
  • 6.4.3 Have Prescription Drug Advertising Led to Escalation in Higher Healthcare Costs?
  • 6.4.4 The Effect of Competition on Pharma DTC Advertising Budgets

7. Market-Leading Brand Name Prescription Drugs

• 7.1 The Top 5 Prescription Therapeutics by DTC advertising expenditure
  • 7.1.1 Merckis Vioxx promoted by DDB Worldwide Communications Group: Market-leading prescription drug by DTC Expenditure
  • Graph 23. Top 5 Prescription Drugs by DTC Advertising Expenditure
  • 7.1.2 Pharmacia & Pfizeris Celebrex promoted by J. Walter Thompson Healthcare Group
  • 7.1.3 AstraZenecais Nexium promoted by Klemtner Advertising Inc
  • 7.1.4 Pfizeris Viagra promoted by Cline, Davis & Mann Inc
  • 7.1.5 Aventisi Allegra promoted by McCann-Erickson Consumer Health
  • Box 10. The Impact of DTC Advertising & Pfizeris Viagra drug
  • Table 17. Top 35 Prescription Brands of 2001 by DTC Advertising Expenditure
  • Graph 24. Top 35 Prescription Brands by DTC Advertising Expenditure

8. Leading Pharmaceutical Companies by DTC Promotional Expenditure

• Table 18. Top 20 Pharmaceutical Companies by DTC Promotional Spending in 2001
• Graph 25. Top 20 Leading Pharmaceutical Companies of 2001 by DTC Promotional Expenditure

9. Advertising Agencies for DTC Prescription Drug Brands

• Table 19. Advertising Agencies for DTC Prescription Drug Brands

10. Ensuring Marketing Success of Brand Name Prescription Therapeutics

• 10.1 Global Brand Management & Marketing
• 10.2 Why Invest in Global Branding & Marketing?
  • 10.2.1 Develop an Effective & Powerful Global Brand
  • 10.2.2 Increase Investor Confidence in the Company & its Product
  • 10.2.3 Reduce Overall Marketing Costs
  • 10.2.4 Increase Product Sale Revenues & Performance
• 10.3 What are the Benefits of Global Branding?
  • Figure 2.The Impact of Global Branding & Marketing of Therapeutic Products
• 10.4 Billion-Dollar Brand Name Therapeutics
  • Table 20. Billion-Dollar Brand Name Therapeutics
  • Graph 26. Top 10 Billion-Dollar Brand Name Therapeutics of 2001
• 10.5 What are the Key Factors to Developing a Successful Global Brand Strategy?
  • 10.5.1 Targeting a Multinational Audience
  • 10.5.2 Increase Brand Awareness & Recognition
  • 10.5.3 Employing the Services of Advertising Agencies to Launch Global Brands & Manage Promotional Campaigns
  • 10.5.4 Ensure Consistent & Effective Global Brand Communication
  • 10.5.5 Establishing a Clear Brand Promise to Patients
  • 10.5.6 Develop a Global Marketing Structure that Functions Locally
• 10.6 The Common Technical Document
  • 10.6.1 What is the Common Technical Document?
  • 10.6.2 The ICH & Implementation of the Common Technical Document
  • 10.6.3 The 6 Regulatory Bodies that Constitute the ICH
  • 10.6.4 Observers & other Partners Linked to the ICH
  • 10.6.5 About the ICH
  • Box 11. Pharmaceutical Markets where DTC Advertising of Prescription Drugs are Permitted
• 10.7 Pharmaceutical Companies & Global Brands
  • Table 21. Advertising Agencies with Global Pharmaceutical Accounts
• 10.8 The Role of Advertising Agencies in the Promotion & Management of Global Brands
  • Figure 3. The Marketing Mix
  • Box 12. The Marketing Mix & Product Promotion

11. Promotion of Brand Prescription Therapeutics in Non-U.S. Markets

• 11.1 The U.S. Model of DTC Advertising of Prescription Therapeutics & Regulations for the Pharmaceutical Industry
  • Box 13. Key Facts about the U.S. Pharmaceutical Industry & DTC Advertising:
  • 11.1.1 Prescription Drug Promotion Targeting Physicians in Non-U.S. Pharmaceutical Markets
• 11.2 Self-Regulation of DTC Advertising of Prescription Medicines in New Zealand
  • 11.2.1 DTC Advertising Expenditure in New Zealand
  • 11.2.2 Regulatory Policies & Guidelines for Advertisement Content
  • Box 14. The Medicines Regulations (1984)
  • 11.2.3 Additional Factors to be Considered for DTC Advertisement of Prescription Therapeutics
  • 11.2.4 Labeling Regulations for the Promotion of Prescription Drugs
  • 11.2.5 Differences in Regulatory Environments of New Zealand & U.S. for Advertising Prescription Therapeutics to Consumers
  • Box 15. Does the Self-Regulatory Approach to DTC Advertising Work in New Zealand work?
• 11.3 Regulations Concerning Prescription Drug Promotion & Advertising in the UK
  • 11.3.1 The Medicine Control Agencyis Standards on Internet Advertising of Prescription Therapeutics
  • 11.3.2 Selected Points from the Association of British Pharmaceutical Industryis (ABPI) Code of Practice on Internet Advertising
  • 11.3.2(a) Clause 21 - The Internet
  • Box 16. Notes on Advertising Clauses
• 11.4 Promotion of Prescription Drugs in the Europe & Ecis Proposal for a Legislative Change
  • 11.4.1 A Step Closer Towards DTC Advertising of Prescription Drugs
  • 11.4.2 Changing Attitudes to DTC Advertising in Europe
  • 11.4.3 Implications of Legislative Change for DTC Advertising
  • 11.4.4 Ecis Reasons for Legislative Change on DTC Advertising
  • 11.4.5 Background to European Regulations on DTC Marketing of Prescription Therapeutics
  • 11.4.6 The Opposition to DTC Advertising in EU Member States
• 11.5 Prescription Drug Promotion in Australia
  • 11.5.1 Key Points on the Regulation of Prescription Drug Advertisements in the Australian Pharmaceutical Market
• 11.6 Prescription Drug Promotion in Canada

12. Recent Developments in the Market of Prescription Drug Promotion

• 12.1 Schering Laboratoriesi Clarinex Advertisement to Consumers
• 12.2 Collaborations to Jointly Promote Prescription Drugs
• 12.3 RxCentrix to Enhance Online E-marketing of Prescription Drugs to Physicians in Europe
  • Box 17. Facts & figures from a recent survey on the Impact of e-detailing to physicians
• 12.4 AstraZeneca to Market Crestor in Japan

13. Visiongain Analysis

• 13.1 The Market Value of the Worldwide Pharmaceutical Industry
  • Graph 27. The Value of Regional Pharmaceutical Markets in the 12 Months to July 2002
• 13.2 Key Promotional Spending Channels
  • Graph 28. Pharmaceutical Promotional Expenditure by Channels in 2001
• 13.3 Recent Trends in DTC Advertising in the U.S
  • Graph 29. Trends in Promotional Spending on DTC Advertising (1996-2000)
  • Graph 30. Total Promotional Spending on DTC Advertising (1996-2000)
• 13.4 Slowdown in U.S. Promotional Expenditure
  • 13.4.1 Reasons for the recent slowdown in the prescription advertising to consumers
  • Graph 31. Percentage Year-on-Year Increase in Total Promotional Spending
  • Graph 32. Trends in Total Pharmaceutical Promotional Expenditure
• 13.5 Detailing to Physicians - The Main Promotional Strategy in Prescription Drug Marketing
  • Graph 32. Trends in Promotional Spending to Healthcare Professionals
  • Graph 33. Total Promotional Spending to Healthcare Professionals
  • Graph 34. Forecast of Total Advertising Expenditure by Pharmaceutical Companies in the U.S.
• 13.6 The Emerging Market of E-Detailing & Prescription Drug Promotion in Cyberspace
  • 13.6.1 Issues that Affect Prescription Therapeutic Promotion to Consumers & Physicians Online
• 13.7 The Emergence of E-Detailing & Advantages over Traditional Detailing Models
  • Graph 35. Projected Market Value of Online Drug Sales by 2005
• 13.8 Market-Leading Brand Name Prescription Therapeutics & Advertising Agencies
• 13.9 Ensuring the Success of Brand Name Prescription Drugs with Global Marketing
  • 13.9.1 The Benefits of a Global Marketing Strategy
  • 13.9.2 The Common Technical Document & Global Marketing
• 13.10 The 6 Key Points to Developing an Effective Global Marketing Strategy
• 13.11 The Promotion of Brand Name Prescription Therapeutics in Non-U.S. Markets
  • 13.11.1 DTC Advertising in U.S, New Zealand & Europe
• 13.12 Closing Comments - The Future of Prescription Drug Promotion

Appendix 1. Regulations & Guidelines on Pharmaceutical Advertisements Directed Toward Consumers in the U.S.

• Appendix 1.1 DTC Advertising Regulations in the U.S
  • Appendix 1.1.1 General Requirements for Prescription Drug Advertisements
  • Appendix 1.1.2 Print Advertisements Versus Broadcast Advertisements
  • Appendix 1.1.3 Information that must be Included in the Major Statement
  • Appendix 1.1.4 Differences between Brief Summary & Approved Labeling
  • Appendix 1.1.5 When do promotional materials need to be submitted to DDMAC?
  • Appendix 1.1.6 Do all promotional materials for prescription drugs have to be submitted to DDMAC?
  • Appendix 1.1.7 What form should applicants use to submit materials to FDA?
  • Appendix 1.1.8 Re-Distribution Submissions
• Appendix 1.2 Reminder Advertisements & Labeling
• Appendix 1.3 FDA Regulations & Guidelines on Prescription Drug Advertising
  • Appendix 1.3.1 Prescription Drug Advertising Defined
  • Appendix 1.3.2 Information that Must be Included in Prescription Drug Advertisements
  • Appendix 1.3.3 Exceptions to Advertising Regulations
  • Appendix 1.3.4 Labeling Defined
  • Appendix 1.3.5 Information that must be Included in the Labeling
  • Appendix 1.3.6 Exceptions to the Requirements of Labeling
• Appendix 1.4 The Enforcement of Prescription Drug Advertising & Labeling Guidelines

Appendix 2. Direct-to-Consumer Advertising Expenditure by Pharmaceutical Company

• Table 36. Direct-to-consumer spending by pharmaceutical company

Appendix 3. Direct-to-Consumer Spending by Brand Name Prescription Therapeutic

• Table 37. Top 105 Brand Name Prescription Therapeutic by DTC Spending

Appendix 4. About visiongain

List of Governmental, Regulatory Bodies & Organizations Mentioned in this Report:

• American Medical Association (AMA)
• Association of British Pharmaceutical Industry (ABPI)
• European Commission (EC)
• European Federation of Pharmaceutical Industries & Associations (EFPIA)
• European Free Trade Area (EFTA)
• Federal Trade Commission (FTC)
• Food and Drug Administration (FDA)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• Kaiser Foundation
• Ministry of Health and Welfare (MHW)
• National Institute for Health Care Management and Research (NIHCMR)
• National Institute of Clinical Excellence (NICE)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Public Citizen
• The International Federation of Pharmaceutical Manufacturers
• Association (IFPMA)
• World Health Organization (WHO)

List of Pharmaceutical Companies Mentioned in this Report:

• 3M
• Abbott Laboratories
• Alcon Laboratories
• Alza
• Amersham
• Amgen
• AstraZeneca
• Aventis
• Berlex Laboratories
• Boehringer Ingelheim
• Bristol-Myers Squibb
• Celltech
• CollaGenex Pharmaceuticals
• Connetics & MGI Pharma
• Dermik Laboratories
• Eisai
• Eli Lilly
• First Horizon
• Forest Laboratories
• Fujisawa Healthcare
• Galderma
• Gilead Sciences
• GlaxoSmithKline
• Johnson & Johnson
• Kos Pharmaceuticals
• Merck & Co
• Northern Research Laboratories
• Novartis
• Organon
• Pfizer
• Pharmacia
• Proctor & Gamble
• Reliant Pharmaceuticals
• Roche
• Salix Pharmaceuticals
• Sankyo
• Schering-Plough
• Shire
• Takeda
• Tap Pharmaceutical
• Wyeth

List of Advertising & Healthcare Communication Agencies Mentioned in this Report

• 30 West Advertising
• Abelson-Tayler
• Accel Healthcare
• Adair-Greene Healthcare
• Adient
• Bates USA
• Cline, Davis & Mann Inc
• Corbett Worldwide Healthcare
• DDB Worldwide Communications Group
• Deutsch
• Donahoe Purohit Miller
• Draftworldwide
• FCB Healthworks
• Gerbig, Snell/Weisheimer
• Gerbig, Snell/Weisheimer & Associates
• Goble & Associates
• Grey Healthcare Group
• Grey Worldwide
• Hamilton Communications Group
• Harrison & Star Business Group
• Healthworld
• Integrated Communications
• Interlink Healthcare Communications
• J. Walter Thompson Healthcare Group
• Kane and Finkel Healthcare
• Klemtner Advertising Inc
• KPR
• LeoHealth
• LM & P Group
• Lyons Lavey Nickel Swift
• McCann-Erickson Consumer
• Health
• Medicus Group International
• Merkley Newman Harty
• Messner, Vetere, Berger, McNamee,
• Schmetterer
• NCI Advertising
• Ogilvy & Mather Worldwide
• OgilvyOne Worldwide
• Omnicom
• Pace Inc.
• Pacific Communications
• Regan Campbell Ward
• Ribotsky Worldwide
• Robert A. Becker
• Sudler & Hennessey
• Ted Thomas Associates
• The Hal Lewis Group
• The Quantum Group
• Thomas Ferguson Associates
• Torre Lazur McCann
• Williams-Labadie
• Young & Rubicam