iii
Lifecycle Management Through the Rx-to-OTC Switch
Table of Contents
Chapter 1 The Importance of Rx-to-OTC Switch to Consumer Self-Care.........................................1
Chapter 2 Why Switch? Evaluating the Value of Switch Candidates.................................................13
Chapter 3 What is the Rx-to-OTC switch process in the US and how does FDA
regulate switches?. ..............................................................................................................31
Chapter 4 Plan B Case Study: A Story of Politics Over Science .......................................................51
Chapter 5 Prilosec OTC: A Case Study. ............................................................................................63
Chapter 6 The History and Future of Rx-to-OTC Switch for Lipid Management in the US. ..........81
Chapter 7 Review of the Rx-to-OTC Switch of Oxytrol for Women................................................99
Chapter 8 Differin Gel OTC Switch: Bringing Innovation to a Well-Established Category..........121
Chapter 9 Intranasal Corticosteroids for Allergy OTC Switch: A US Case Study. .........................137
Chapter 10 EU and RoW Switches....................................................................................................161
Chapter 11 Conclusion. ......................................................................................................................179
Abbreviations and Acronyms. ...............................................................................................................187
Glossary of Terms..................................................................................................................................191
Index.....................................................................................................................................................195
Figures
Figure 1-1. Sample Drug Facts Label ....................................................................................................2
Figure 1-2. Self-Care Pyramid. ..............................................................................................................3
Figure 1-3. IRI Value Study for CHPA..................................................................................................4
Figure 1-4. Key Benefits Consumers Cite for OTC Usage. ...................................................................5
Figure 3-1. Value Tree Method for Assessing Potential Benefits and Risks From a Proposed
Rx-to-OTC Switch............................................................................................................33
Figure 3-2. Lotrimin Ultra Pictogram..................................................................................................38
Figure 3-3. Voltaren Arthritis Pain Outer Carton ...............................................................................39
Figure 3-4. Voltaren Arthritis Pain Pictogram. ....................................................................................39
Figure 3-5. OTC Naloxone DFL Created by FDA for CONFER Pivotal Label
Comprehension Study........................................................................................................40
Figure 3-6. Enhanced DFL Warning Tested in SSS for Proposed OTC Singulair Allergy. ................42
Figure 5-1. Frequency of Rx-to-OTC Switches: 1998–2002*. .............................................................64
Figure 5-2. Mechanism of Action of H2RAs and Omeprazole............................................................65
Figure 5-3. Prilosec Black Box Warning...............................................................................................66
Figure 5-4. Percent of Subjects With Complete Prevention of Heartburn—Day 1 ............................69
Lifecycle Management Through the Rx-to-OTC Switch
Table of Contents
Chapter 1 The Importance of Rx-to-OTC Switch to Consumer Self-Care.........................................1
Chapter 2 Why Switch? Evaluating the Value of Switch Candidates.................................................13
Chapter 3 What is the Rx-to-OTC switch process in the US and how does FDA
regulate switches?. ..............................................................................................................31
Chapter 4 Plan B Case Study: A Story of Politics Over Science .......................................................51
Chapter 5 Prilosec OTC: A Case Study. ............................................................................................63
Chapter 6 The History and Future of Rx-to-OTC Switch for Lipid Management in the US. ..........81
Chapter 7 Review of the Rx-to-OTC Switch of Oxytrol for Women................................................99
Chapter 8 Differin Gel OTC Switch: Bringing Innovation to a Well-Established Category..........121
Chapter 9 Intranasal Corticosteroids for Allergy OTC Switch: A US Case Study. .........................137
Chapter 10 EU and RoW Switches....................................................................................................161
Chapter 11 Conclusion. ......................................................................................................................179
Abbreviations and Acronyms. ...............................................................................................................187
Glossary of Terms..................................................................................................................................191
Index.....................................................................................................................................................195
Figures
Figure 1-1. Sample Drug Facts Label ....................................................................................................2
Figure 1-2. Self-Care Pyramid. ..............................................................................................................3
Figure 1-3. IRI Value Study for CHPA..................................................................................................4
Figure 1-4. Key Benefits Consumers Cite for OTC Usage. ...................................................................5
Figure 3-1. Value Tree Method for Assessing Potential Benefits and Risks From a Proposed
Rx-to-OTC Switch............................................................................................................33
Figure 3-2. Lotrimin Ultra Pictogram..................................................................................................38
Figure 3-3. Voltaren Arthritis Pain Outer Carton ...............................................................................39
Figure 3-4. Voltaren Arthritis Pain Pictogram. ....................................................................................39
Figure 3-5. OTC Naloxone DFL Created by FDA for CONFER Pivotal Label
Comprehension Study........................................................................................................40
Figure 3-6. Enhanced DFL Warning Tested in SSS for Proposed OTC Singulair Allergy. ................42
Figure 5-1. Frequency of Rx-to-OTC Switches: 1998–2002*. .............................................................64
Figure 5-2. Mechanism of Action of H2RAs and Omeprazole............................................................65
Figure 5-3. Prilosec Black Box Warning...............................................................................................66
Figure 5-4. Percent of Subjects With Complete Prevention of Heartburn—Day 1 ............................69