1. D-1 FCBPs Who Were Pregnant Prior to Therapy Start Date 1 Prescriber entered “false” pregnancy test results 1 Designee entered “false” pregnancy test results 1 Patient had access to drug from a previous program (2003) 1 Patient claimed false negative pregnancy test result 6 Components of pregnancy test: –Timing relative to first 5 days of menstrual period –Timing relative to unprotected sexual intercourse –Inherent test limitations (N=10)

2. D-2 Non-iPLEDGE* Pregnancies (Source of Exposure to Drug) (N=19) Obtained from outside U.S.2 Obtained from pharmacy2 Accidentally took isotretinoin (instead of ibuprofen)1 Took mother’s prescription1 Unknown13 * Patient not registered in iPLEDGE program

3. D-3 iPLEDGE Pregnancy Cases – Pregnancies by Month iPLEDGE Year 1 MarAprMayJunJulAugSepOctNovDecJanFebTotal 4410 8511 1310187111 * * 11 cases had no known conception date nor had information to impute a conception date iPLEDGE Year 2 MarAprMayJun 111583

4. D-4 iPLEDGE Year 2 Pregnancies 4 Month Data (March-June 2007) Description of Conception Date N (N=37)% Prior to starting isotretinoin treatment12.7 During isotretinoin treatment2567.6 Within 30 days after isotretinoin treatment completion 924.3 Unknown25.4 Relative Timing to Isotretinoin Exposure Data to June 30, 2007 Number of RCA Forms completedN=1437.8%

5. D-5 SAB Membership Paul BeBeau, MD Roche Cathleen M. Boeck, RN, CCRC, DNC Dermatology Nurses Association Bruce Bottini Mylan Labs Laura Saul Edwards American Academy of Dermatology Association Stephan P. Stone, MD, FAAD American Academy of Dermatology Association Tom Davis, R.Ph.CVS Pharmacy, Inc. Anita Ducca, MS Healthcare Distribution Management Association (HDMA) Joseph P. Lech, R.Ph. National Community Pharmacists Association

6. D-6 SAB Membership (cont.) Rufino Santiago, MD Ranbaxy Anthony Oladipo Barr Labs Katharine O'Connell, MD, MPH Columbia University Medical Center Ronna B. Hauser, Pharm.D. National Association of Chain Drug Stores (NACDS) Shelia Weiss Smith, Ph.D. University of Maryland LaDonna Williams Inflammatory Skin Disease Institute

7. D-7 Pre- S.M.A.R.T. S.M.A.R.T. Year 1 S.M.A.R.T. Year 2 S.M.A.R.T. Year 3 S.M.A.R.T. Year 4* Total number 218224229190123 S.M.A.R.T. - Pregnancy Case Reports (All Manufacturers) * Data to February 28, 2006

8. D-8 iPLEDGE – Birth Outcomes (to June 25, 2007) Elective termination54 Spontaneous abortion17 Live birth1 Still continuing15 Unknown35 Total122

9. D-9 Females of Child-Bearing Potential Definition A non-menopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure. This includes a young woman who has not yet started menstruating. –A woman who has had a tubal sterilization is considered a female patient of childbearing potential in the iPLEDGE program

10. D-10 Estimated Patient Exposure to Isotretinoin Year Male (Net) Projected* Female (Net) Projected* 2000260,987234,244 2001211,371179,333 2002177,322131,064 2003174,367130,470 2004173,732145,042 2005151,819132,486 * Projected Patient Exposure = Total Prescription / 4 Source: IMS, NPA, PDDA Data MAT Sep