ISOTRETINOIN ENHANCED RISK MANAGEMENT PROGRAM

1
ISOTRETINOIN ENHANCED RISK MANAGEMENT PROGRAM

• Program Elements for Which Advisory Committee
  Input is Requested
• Genpharm Inc. Mylan/Bertek
  Pharmaceuticals Inc.
• Barr Laboratories, Inc. Ranbaxy
  Pharmaceuticals Inc.

For Presentation at FDA Advisory Committee
Meeting Presenter Robert W. Pollock February
26 and 27, 2004 Vice President
Lachman Consultant Services Inc.
2
Issues for Further Discussion

• (l) Registration of male patients in addition to
  female patients versus only female patients
• (2) Patient interaction with the educational and
  risk management evaluation component of the
  program and
• (3) A firmer link between the registry and the
  pharmacist - perhaps through pharmacy
  registration.

3
Considerations for Discussion Request for
Advisory Committee Input

• (l) Registration of male patients in addition to
  female patients versus only female patients.
• Focus is to reduce fetal exposure
• Approximately 50 of patients are male
• Sticker differentiates between male and female

4
Considerations for Discussion Request for
Advisory Committee Input

• (2) Patient interaction with the educational and
  risk management evaluation component of the
  program.
• What should be the purpose of the interaction?
• Reinforce education
• Define and enforce compliance
• Should there be a No Drug provision for
  inappropriate response to interactions?
• How to deal with impact on potential interruption
  of treatment program with No Drug provision and
  a negative pregnancy test?

5
Considerations for DiscussionRequest for
Advisory Committee Input

• (3) A firmer link between the registry and the
  pharmacist - perhaps through pharmacy
  registration.
• Is this sufficiently addressed by requirement of
  hard link to a lab based negative pregnancy test?
• Isotretinoin label revision to permit dispensing
  only if prescription is authorized by the
  registry (i.e., pharmacist must verify patient
  eligibility and obtain authorization number for
  each prescription through interaction with
  registry. Authorization number must be recorded
  on the Rx.
• Should control factor be the practice of pharmacy
  or should there be a more restrictive
  requirement?