FDA BACKGROUND PACKAGE
Joint Drug Safety and Risk Management &
Dermatologic and Ophthalmic Drugs
Advisory Committees Meeting
February 26 & 27, 2004
Table of Contents
Section
A:
Office
of Drug Evaluation V
Division
of Dermatologic and Dental Drug Products Materials
Tab 1: Background of Isotretinoin Teratogenic Risk Management Plan
(Isotretinoin Historical Summary)
Tab 2: Letter from Dr. Janet Woodcock to Hoffman-La Roche, Inc.
Dated: October 6, 2000
Subject: Need for registry, linkage of pregnancy status with drug dispensing
( Note to Committee: registry
not implemented per innovator due to
HIPAA and other
constraints, so S.M.A.R.T.™ program evolved over 1 year
prior to
implementation)
Tab 3: Letter from Dr. Jonathan Wilkin to Hoffman-La Roche, Inc.
Dated: October 30, 2001
Subject: Approval letter for Accutane® (Isotretinoin) – NDA 18-662/S-044
Tab 3a: Final product labeling for Accutane® (Isotretinoin) – October 2001
Tab 3b: Patient Information/Consent (for female patients)
Tab 3c: Informed Consent/Patient Agreement (for all patients)
Tab 3d: Accutane® (Isotretinoin) Medication Guide
Tab 3e: System to Manage Accutane® Related Teratogenicity (S.M.A.R.T.)™
Letter of Understanding for Prescribers
Tab 3f: FDA letter to all U.S. Boards of Pharmacy re: S.M.A.R.T.™ Program launch
Tab 3g: FDA letter to all pharmacists re: New Dispensing Procedures for Accutane®
Tab 3h: FDA letter to all prescribers re: New Dispensing Procedures for Accutane®
Tab 3i: Patient Product Information
FDA BACKGROUND PACKAGE
Joint Drug Safety and Risk Management &
Dermatologic and Ophthalmic Drugs
Advisory Committees Meeting
February 26 & 27, 2004
Table of Contents (cont.)
Section
B:
Office of Pharmaceutical Science
Office of Generic Drugs Materials
Letter from Dr. Janet Woodcock to Ellen J. Flannery, Esq.
Dated: November 8, 2002
Subject: Response to Citizen Petition, dated February 25, 2002
Re: Procedures and Standards; Abbreviated New Drug Approvals (NDAs)
Section
C:
Office
of Pharmacoepidemiology and Statistical Science
Office
of Drug Safety Materials
Executive
Overview – Office of Drug Safety (ODS)
Combined
Review – Division of Drug Risk Evaluation and Surveillance,
Research, and Communications Support, ODS
Tab 1: Overview of the 1st Year of the Isotretinoin Risk Management Program (RMP), dated 1/29/04
Tab 2: Overview of the First Year Evaluation of the Isotretinoin Risk Management Program
(Executive Summary), dated 2/2/04
Tab 3: PID D030417,
Drug: Isotretinoin, Topic: Pregnancy Exposures, dated 2/2/04
Tab 4: PID D030417,
Drug: Isotretinoin, Topic: Isotretinoin Utilization, dated 2/2/04
Tab 5: PID D030417, Drug: Isotretinoin, Topic: Review of Prescription Compliance Survey
to Measure Compliance with Isotretinoin
Qualification Stickers, dated 2/2/04
Tab 6: PID D030417, Drug: Isotretinoin, Topic: Review of Prescription Survey Materials and
Data with Interest in Compliance during the
First Year of the System to Manage Accutane®
Related Teratology (S.M.A.R.T.)™ Program,
dated 2/2/04
Tab 7: A Synopsis of the Elements of the S.T.E.P.S.® (System for Thalidomide Education and
Prescribing Safety) Program, dated 2/2/04
Tab 8: Final Printed labeling for Thalomid® (thalidomide), dated 10/03