Promotion of FDA-Regulated Medical Products iv
Sidebars
Sidebar 1-1. FDA Regulatory Basics. ..........................................................................................................................4
Sidebar 1-2. Best Practices for Interacting With OPDP Reviewers..............................................................................6
Sidebar 1-3. Enforcement Example: YAZ 10/2008.....................................................................................................8
Sidebar 2-1. Enforcement Example Mirapex 9/2008. ...............................................................................................17
Sidebar 2-2. Enforcement Example Focalin XR 5/2011............................................................................................28
Sidebar 2-3. Enforcement Example Idelvion, 2/2018. ..............................................................................................31
Sidebar 2-4. Enforcement Example Estring 6/2018. .................................................................................................32
Sidebar 2-5. Enforcement Example Vantas 9/2012...................................................................................................36
Sidebar 2-6. Enforcement Example Contrave 5/2017...............................................................................................39
Sidebar 2-7. Enforcement Example Muse 5/2004 and 4/1998..................................................................................40
Sidebar 2-8. Enforcement Examples MiraLax 3/2001 and Patanol 3/2001. ..............................................................41
Sidebar 2-9. Enforcement Example Tasigna 7/2010..................................................................................................45
Sidebar 2-10. Enforcement Example NCS Pearson 8/2015. .......................................................................................50
Sidebar 3-1. Enforcement Example LifeCell Corporation 6/2015.............................................................................58
Sidebar 3-2. Enforcement Example Interfall Hydrogel and Teosyal Products, 5/2015...............................................58
Sidebar 3-3. Enforcement Example Advanced Magnetic Research Institute International LLC, 1/2014....................59
Sidebar 3-4. Enforcement Example Exelon 8/2007...................................................................................................60
Sidebar 3-5. Enforcement Example Nalfon 8/2009. .................................................................................................62
Sidebar 4-1. Enforcement Examples Vectibix 5/2010 Entereg 4/2010. ....................................................................68
Sidebar 4-2. Field Force and Reporting Adverse Drug Experiences. ..........................................................................70
Sidebar 4-3. “Vendor Expos” for Medical Devices. ...................................................................................................71
Sidebar 4-4. Enforcement Example: Seroquel 12/2008.............................................................................................73
Sidebar 4-5. FDAMA Section 401............................................................................................................................75
Sidebar 4-6. Enforcement Example Abraxane 12/2011.............................................................................................78
Sidebar 4-7. Enforcement Example Chiasma, Inc. and Zydus Discovery, 12/2016. ..................................................80
Sidebar 5-1. DTC Advertising of Prescription Medical Devices................................................................................84
Sidebar 5-2. Enforcement Example Fosrenol 11/2009..............................................................................................88
Sidebar 5-3. Enforcement Example Incivek 5/2012..................................................................................................92
Sidebar 5-4. Enforcement Example Doxylamine Succinate and Pyrodoxine Hydrochloride, 8/2015........................96
Sidebar 6-1. Competent and Reliable Evidence. .....................................................................................................102
Sidebars
Sidebar 1-1. FDA Regulatory Basics. ..........................................................................................................................4
Sidebar 1-2. Best Practices for Interacting With OPDP Reviewers..............................................................................6
Sidebar 1-3. Enforcement Example: YAZ 10/2008.....................................................................................................8
Sidebar 2-1. Enforcement Example Mirapex 9/2008. ...............................................................................................17
Sidebar 2-2. Enforcement Example Focalin XR 5/2011............................................................................................28
Sidebar 2-3. Enforcement Example Idelvion, 2/2018. ..............................................................................................31
Sidebar 2-4. Enforcement Example Estring 6/2018. .................................................................................................32
Sidebar 2-5. Enforcement Example Vantas 9/2012...................................................................................................36
Sidebar 2-6. Enforcement Example Contrave 5/2017...............................................................................................39
Sidebar 2-7. Enforcement Example Muse 5/2004 and 4/1998..................................................................................40
Sidebar 2-8. Enforcement Examples MiraLax 3/2001 and Patanol 3/2001. ..............................................................41
Sidebar 2-9. Enforcement Example Tasigna 7/2010..................................................................................................45
Sidebar 2-10. Enforcement Example NCS Pearson 8/2015. .......................................................................................50
Sidebar 3-1. Enforcement Example LifeCell Corporation 6/2015.............................................................................58
Sidebar 3-2. Enforcement Example Interfall Hydrogel and Teosyal Products, 5/2015...............................................58
Sidebar 3-3. Enforcement Example Advanced Magnetic Research Institute International LLC, 1/2014....................59
Sidebar 3-4. Enforcement Example Exelon 8/2007...................................................................................................60
Sidebar 3-5. Enforcement Example Nalfon 8/2009. .................................................................................................62
Sidebar 4-1. Enforcement Examples Vectibix 5/2010 Entereg 4/2010. ....................................................................68
Sidebar 4-2. Field Force and Reporting Adverse Drug Experiences. ..........................................................................70
Sidebar 4-3. “Vendor Expos” for Medical Devices. ...................................................................................................71
Sidebar 4-4. Enforcement Example: Seroquel 12/2008.............................................................................................73
Sidebar 4-5. FDAMA Section 401............................................................................................................................75
Sidebar 4-6. Enforcement Example Abraxane 12/2011.............................................................................................78
Sidebar 4-7. Enforcement Example Chiasma, Inc. and Zydus Discovery, 12/2016. ..................................................80
Sidebar 5-1. DTC Advertising of Prescription Medical Devices................................................................................84
Sidebar 5-2. Enforcement Example Fosrenol 11/2009..............................................................................................88
Sidebar 5-3. Enforcement Example Incivek 5/2012..................................................................................................92
Sidebar 5-4. Enforcement Example Doxylamine Succinate and Pyrodoxine Hydrochloride, 8/2015........................96
Sidebar 6-1. Competent and Reliable Evidence. .....................................................................................................102