Rx-to-OTC Switches
iv
Figure 5-5. Percent of Days with No Heartburn—Over 14 Days. .......................................................70
Figure 5-6. Percent of Subjects with 24 Hour Prevention of Heartburn—Time Course Over
14 Days (Studies 171 and 183). .........................................................................................72
Figure 6-1. Schematic Outline of Mevacor OTC Consumer Behavior Studies in 1999 NDA............86
Figure 6-2. The Mevacor OTC Self-Management System—2005......................................................89
Figure 6-3. Mevacor OTC Back Panel Drugs Facts Label Used in CUSTOM Study.........................90
Figure 6-4. Mevacor OTC “5th Panel” Self-Selection Labeling Aid Used in SELECT Study............93
Figure 8-1. Timeline for Rx-to-OTC Switch of Differin Gel............................................................123
Figure 8-2. Comparison of Final OTC DFL for Differin Gel to DFL for a Representative Acne
Product Labeled According to the OTC Topical Acne Drug Products Monograph. ......124
Figure 8-3. Results of NDAC Vote on Rx-to-OTC Switch of Differin Gel......................................133
Tables
Table 2-1. Brands Launched via Rx-to-OTC Switch Since 2000 and Most Recent Annual US
Retail Sales.........................................................................................................................15
Table 2-2. OTC Therapeutic Categories and 2020 Annual US Retail Sales. ......................................16
Table 2-3. Allergy Brands Launched as a Result of Rx-to-OTC Switch and Their Most Recent
Annual US Retail Sales......................................................................................................17
Table 2-4. Source of Volume for Recent Allergy Rx-to-OTC Switches.............................................17
Table 2-5. US Retail Sales by Year of Allergy Products (NSAs versus INSs)......................................18
Table 2-6. Dollar Share of Retail Sales in Drug Stores (Branded Products Versus Private Label
Smoking Cessation Products). ...........................................................................................18
Table 2-7. PPI Brands Launched as a Result of Rx-to-OTC Switch, Peak Rx Sales and Most
Recent Annual US Retail Sales..........................................................................................19
Table 2-8. Reported Media Spends and Year 1 US Retail Sales for Certain Recent Rx-to-OTC
Switch Brands. ...................................................................................................................20
Table 2-9. Pricing Premiums for new Waves of Innovation (Based on Class of OTC Chemical
Entity) Versus the Previous Wave of Innovation................................................................22
Table 2-10. Order of Entry for Various Rx-to-OTC Switches (by Class) Versus Current
Sales Rank..........................................................................................................................23
Table 2-11. Advil Products Approved via new NDAs (and Year of Approval)......................................23
Table 2-12. Key Differences Between Prescription and Consumer Healthcare Business Models.........26
Table 3-1. Typical Rx-to-OTC Switch Studies and the Parameters They can Measure. ....................36
Table 3-2. Various Naming Approaches Used Over Last 10 Years. ....................................................41
Table 3-3. Primary Endpoints From Recent AUS Point to These Behavioral Measures.....................43
Table 3-4. Elapsed Approval Times for Rx-to-OTC Switches...........................................................46
Table 3-5. NDAC Advisory Committee Meetings in the Last Decade and Their Rx-to-OTC
Switch Votes.......................................................................................................................47
Table 4-1. Summary of Label Comprehension Results by Age...........................................................53
Table 4-2. Summary of the Eight Advance Provision Studies. ...........................................................56
Table 4-3. Survey Summary. ...............................................................................................................58
Table 6-1. Clinical Studies Supporting Merck’s 1999 NDA to Switch Lovastatin.............................85
Table 6-2. BMS Pravachol Switch Program: Proposed Target OTC Population................................86
Table 6-3. Merck 2005 Statin Switch Program: Target OTC Population for CUSTOM Study........91
Table 9-1. Examples of Lifecycle Management in Prescription Allergy Products (Pre-Switch).......139
iv
Figure 5-5. Percent of Days with No Heartburn—Over 14 Days. .......................................................70
Figure 5-6. Percent of Subjects with 24 Hour Prevention of Heartburn—Time Course Over
14 Days (Studies 171 and 183). .........................................................................................72
Figure 6-1. Schematic Outline of Mevacor OTC Consumer Behavior Studies in 1999 NDA............86
Figure 6-2. The Mevacor OTC Self-Management System—2005......................................................89
Figure 6-3. Mevacor OTC Back Panel Drugs Facts Label Used in CUSTOM Study.........................90
Figure 6-4. Mevacor OTC “5th Panel” Self-Selection Labeling Aid Used in SELECT Study............93
Figure 8-1. Timeline for Rx-to-OTC Switch of Differin Gel............................................................123
Figure 8-2. Comparison of Final OTC DFL for Differin Gel to DFL for a Representative Acne
Product Labeled According to the OTC Topical Acne Drug Products Monograph. ......124
Figure 8-3. Results of NDAC Vote on Rx-to-OTC Switch of Differin Gel......................................133
Tables
Table 2-1. Brands Launched via Rx-to-OTC Switch Since 2000 and Most Recent Annual US
Retail Sales.........................................................................................................................15
Table 2-2. OTC Therapeutic Categories and 2020 Annual US Retail Sales. ......................................16
Table 2-3. Allergy Brands Launched as a Result of Rx-to-OTC Switch and Their Most Recent
Annual US Retail Sales......................................................................................................17
Table 2-4. Source of Volume for Recent Allergy Rx-to-OTC Switches.............................................17
Table 2-5. US Retail Sales by Year of Allergy Products (NSAs versus INSs)......................................18
Table 2-6. Dollar Share of Retail Sales in Drug Stores (Branded Products Versus Private Label
Smoking Cessation Products). ...........................................................................................18
Table 2-7. PPI Brands Launched as a Result of Rx-to-OTC Switch, Peak Rx Sales and Most
Recent Annual US Retail Sales..........................................................................................19
Table 2-8. Reported Media Spends and Year 1 US Retail Sales for Certain Recent Rx-to-OTC
Switch Brands. ...................................................................................................................20
Table 2-9. Pricing Premiums for new Waves of Innovation (Based on Class of OTC Chemical
Entity) Versus the Previous Wave of Innovation................................................................22
Table 2-10. Order of Entry for Various Rx-to-OTC Switches (by Class) Versus Current
Sales Rank..........................................................................................................................23
Table 2-11. Advil Products Approved via new NDAs (and Year of Approval)......................................23
Table 2-12. Key Differences Between Prescription and Consumer Healthcare Business Models.........26
Table 3-1. Typical Rx-to-OTC Switch Studies and the Parameters They can Measure. ....................36
Table 3-2. Various Naming Approaches Used Over Last 10 Years. ....................................................41
Table 3-3. Primary Endpoints From Recent AUS Point to These Behavioral Measures.....................43
Table 3-4. Elapsed Approval Times for Rx-to-OTC Switches...........................................................46
Table 3-5. NDAC Advisory Committee Meetings in the Last Decade and Their Rx-to-OTC
Switch Votes.......................................................................................................................47
Table 4-1. Summary of Label Comprehension Results by Age...........................................................53
Table 4-2. Summary of the Eight Advance Provision Studies. ...........................................................56
Table 4-3. Survey Summary. ...............................................................................................................58
Table 6-1. Clinical Studies Supporting Merck’s 1999 NDA to Switch Lovastatin.............................85
Table 6-2. BMS Pravachol Switch Program: Proposed Target OTC Population................................86
Table 6-3. Merck 2005 Statin Switch Program: Target OTC Population for CUSTOM Study........91
Table 9-1. Examples of Lifecycle Management in Prescription Allergy Products (Pre-Switch).......139