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