iPLEDGE Update: Introduction

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iPLEDGE Update Introduction

• Jill Lindstrom, MD FAAD
• Acting Deputy Division Director
• Division of Dermatologic and Dental Products

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Isotretinoin

• Indication treatment of severe recalcitrant
  nodular acne
• Known teratogen
• Long history of progressive risk minimization
  steps
• Labeling
• APPP
• Sticker program

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2004 DSaRM DODAC Recommendations

• Sticker risk management program needs revision
• Multiple programs/names/logos confusing

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2004 DSaRM DODAC Recommendations

• Registration of all patients, male and female
• Registration of prescribers
• Registration of pharmacies
• Tightened linkage between pregnancy testing and
  dispensing of isotretinoin
• Pregnancy registry for root cause analysis

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Steps Taken

• CDER working group (OND, OGD, ODS, OC, PLT)
  established March 2004
• Initial meeting with sponsors on April 2004
• White paper completed July 2004
• Sponsors presented high-level overview in
  September 2004, submission timeline in December
  2004
• Labeling supplement submitted June 24, 2005

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iPLEDGE Dates

• Approved under Subpart H August 12, 2005
• Stakeholder registration (wholesalers and
  pharmacies) began in September 2005
• Launched December 30, 2005
• Transition will be complete March 1, 2006

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iPLEDGE
Registered Activated Prescribers
Rx
Rx
Registered Patients
Registered Activated Pharmacies
Registered Wholesalers
iPLEDGE System
Only qualified patients receive isotretinoin
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Unique Aspects of iPLEDGE

• First performance-linked access system for
  widely-prescribed drug
• Single consolidated risk minimization action plan
  for both innovator and generic products
• Multi-source marketplace

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Next Steps

• Program refinements
• Metrics