Promotion of FDA-Regulated Medical Products iii
Contents
Part I: Fundamentals. ..........................................................................................................................................1
Chapter 1 Introduction to the Agencies Involved in Prescription Drug and Device Labeling.................................. 3
Chapter 2 Fundamental Principles for Labeling and Promotion of Prescription Medical Products........................ 13
Chapter 3 Labeling and Promotion of Regulated Products Prior to Approval and Off-Label Promotion............... 55
Part II: Communications to Certain Audiences. ................................................................................................65
Chapter 4 Promotion to Healthcare Professionals and Providers........................................................................... 67
Chapter 5 Direct Promotion of Prescription Products to Consumers and Patient Populations.............................. 83
Chapter 6 Promotion to Payers and Other Sophisticated Audiences. ..................................................................101
Part III: Practical Advice for Regulatory Professionals..................................................................................... 105
Chapter 7 Additional Regulatory and Legal Considerations. ..............................................................................107
Appendix 1. Selected Sections of the FD&C Act. ...................................................................................................111
Appendix 2. Selected FD&C Act Regulations......................................................................................................... 125
Appendix 3. List of Available Guidances Regarding the Labeling, Advertising and Promotion of
Prescription Drugs............................................................................................................................. 163
Glossary. .................................................................................................................................................................167
Index....................................................................................................................................................................... 173
Figures
Figure 1-1. Organization Chart of FDA’s Office of Medical Products and Tobacco...................................................5
Tables
Table 2-1. Selected FDA Regulations for the Labeling of Prescription Drugs.........................................................14
Table 2-2. Selected FDA Regulations for Device Labeling. ....................................................................................15
Table 2-3. FDA’s Categorization of Promotional Materials (21 CFR 202.1(l)).......................................................16
Table 2-4. Summary of PI Sections Under the PLR, Including Relevant Regulations and Available Guidance.......22
Table 2-5. Other Product Claim Types. .................................................................................................................30
Table 2-6. Risk-Related Sections of the PI Ranked From Most to Least Important................................................34
Table 5-1. Milestones in DTC Regulation.............................................................................................................86
Contents
Part I: Fundamentals. ..........................................................................................................................................1
Chapter 1 Introduction to the Agencies Involved in Prescription Drug and Device Labeling.................................. 3
Chapter 2 Fundamental Principles for Labeling and Promotion of Prescription Medical Products........................ 13
Chapter 3 Labeling and Promotion of Regulated Products Prior to Approval and Off-Label Promotion............... 55
Part II: Communications to Certain Audiences. ................................................................................................65
Chapter 4 Promotion to Healthcare Professionals and Providers........................................................................... 67
Chapter 5 Direct Promotion of Prescription Products to Consumers and Patient Populations.............................. 83
Chapter 6 Promotion to Payers and Other Sophisticated Audiences. ..................................................................101
Part III: Practical Advice for Regulatory Professionals..................................................................................... 105
Chapter 7 Additional Regulatory and Legal Considerations. ..............................................................................107
Appendix 1. Selected Sections of the FD&C Act. ...................................................................................................111
Appendix 2. Selected FD&C Act Regulations......................................................................................................... 125
Appendix 3. List of Available Guidances Regarding the Labeling, Advertising and Promotion of
Prescription Drugs............................................................................................................................. 163
Glossary. .................................................................................................................................................................167
Index....................................................................................................................................................................... 173
Figures
Figure 1-1. Organization Chart of FDA’s Office of Medical Products and Tobacco...................................................5
Tables
Table 2-1. Selected FDA Regulations for the Labeling of Prescription Drugs.........................................................14
Table 2-2. Selected FDA Regulations for Device Labeling. ....................................................................................15
Table 2-3. FDA’s Categorization of Promotional Materials (21 CFR 202.1(l)).......................................................16
Table 2-4. Summary of PI Sections Under the PLR, Including Relevant Regulations and Available Guidance.......22
Table 2-5. Other Product Claim Types. .................................................................................................................30
Table 2-6. Risk-Related Sections of the PI Ranked From Most to Least Important................................................34
Table 5-1. Milestones in DTC Regulation.............................................................................................................86