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Executive Summary

ROCHE ACCUTANE ADS EMPHASIZING MD PRESCRIBING PROCEDURE are being prepared for several medical journals, Roche Asst. Director of Professional Services Howard Rofsky, told FDA's Dermatologic Drugs Advisory Cmte. May 14. Rofsky said the ads will appears in a "medical director's page" format and "outline step by step" the procedures for "physician use in prescribing Accutane for female patients." He noted that advertisements are also being prepared for pharmacy journals that instruct the pharmacist to include a warning label and patient insert with each Rx. Following an update by Roche on the status of Accutane, FDA asked the cmte. if additional steps -- other than Roche's revised labeling and letters to physicians and pharmacists -- should be undertaken to minimize risk of Accutane exposure during pregnancy. FDA noted that since the drug's approval, it "has been prescribed in some cases for acne other than recalcitrant cystic acne," thus increasing the likelihood of fetal abnormalities associated with its use. The cmte. agreed that Accutane should continue to be monitored and patients, physicians and pharmacists continue to be educated about the drug. The cmte. vetoed several suggestions for limiting Accutane exposure to the targeted population. For instance, one cmte. member proposed the labeling state that the drug should be prescribed only by a dermatologist. Another member said patients should seek a second opinion as to the need for Accutane treatment. One cmte. member also suggested the drug be prescribed in combination with a contraceptive. Cmte. member Clinton Miller III, PhD, Medical University of South Carolina, asked that Roche "develop fairly solid information" about the prevalence of recalcitrant cystic acne and the total number of patients in the U.S. in order to get "some idea of . . . the actual" amount of over-prescribing. The company said it would try to provide that information. Roche noted that there are currently 40,000 Accutane Rxs per month and 25,000 new patients per month. In its presentation to the cmte., Roche reported that there have been 170 pregnancies in women taking Accutane since the drug's introduction September 1982. Roche Director of Medical Epidemiology Diane Chen said the figure includes 20 reports of congenital malformation, 24 normal births, 14 spontaneous abortions, 75 elective abortions, three false-positive pregnancy tests, four cases lost to follow-up, and 30 cases continuing pregnancy as of March 30. Roche revised the labeling for Accutane in March to highlight the drug's contra-indication in pregnancy and its association with pseudotumor cerebri. The firm distributed letters to MDs and pharmacists at that time and again last month to notify them of Accutane's new trade pakage. The package includes patient information leaflets and pregnancy warning labels to be distributed with each Rx. Roche noted that it is monitoring acceptance of the distribution plan in cooperation with FDA.

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