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Executive Summary

ROCHE ACCUTANE PREGNANCY PREVENTION EFFORTS should be reevaluated in early 1991 when further data from the company's surveillance program is available, FDA's Dermatologic Drugs and Fertility and Maternal Health advisory committees concluded at a joint meeting May 21. "We believe that [Roche] has made an unusually strong effort to develop information for pregnancy prevention for patients and physicians," summarized Fertility and Maternal Health Committee Chairman Barbara Hulka, MD, University of North Carolina. However, she said, "we've made the point that if trends continue...more effort is going to have to be made." Roche is monitoring the effects of its "Pregnancy Prevention Program" through a surveillance study being conducted by Boston University's Slone Epidemiology Unit. Preliminary results from the study were presented to the committees. More substantive results, as well as an assessment of whether the study population is adequately representative of the general female population using Accutane, are expected to be available by the beginning of 1991. Initial results on approximately 5,000 of the 30,000-plus patients in the surveillance study found that 40% of the women using Accutane reported not having a pregnancy test prior to initiating therapy. Roche said it found the 40% figure "disturbing." Slone, however, conducted a followup study on 100 of those patients that indicated that roughly 75% "were likely" to have had a pregnancy test but that they were unaware of it. The Slone study also found that 40% of the women using Accutane reported not having any cysts at the start of treatment, indicating that the drug is still being used beyond its labeled indication for cystic acne that is recalcitrant to standard therapies. Since January 1989, following initiation of Roche's Pregnancy Prevention Program, the company has learned of 43 pregnancy exposures. Information available on 37 of the patients shows that five of the exposures occurred in women who used leftover Accutane capsules to treat themselves without the advice of a physician; eight occurred in women who were pregnant before beginning therapy; and 24 occurred in women who conceived during therapy. The majority of women who conceived during therapy (18 of 24) reported using contraception. Based on the pregnancy figures and preliminary results from the Slone study, the advisory committees recommended four measures to curb pregnancy exposure to the teratogenic compound: (1) Educational materials should further emphasize the importance of a pregnancy test before therapy; (2) Additional attention should be paid to informed consent, with particular attention to the development of non-written materials (such as videotapes) and materials for non-English-speaking people; (3) A mechanism should be developed for the returned of unused Accutane capsules; and (4) Further emphasis should be placed on ensuring that patients get counseling about contraception. Roche, at the beginning of the advisory committee session, proposed a number of similar steps, including additional attention to contraceptive counseling and development of a return goods policy for unused products. In addition, the company said it was considering development of a special preprinted prescription pad for physicians that would reinforce the importance of a negative pregnancy test. Roche said it planned to meet with pharmacy and the medical community to explore the feasibility of such a program. Several presenters at the meeting, including an FDAer, called for more drastic measures to limit pregnancy exposures. David Graham, a staffer from FDA's Office of Epidemiology and Biostatistics who is involved in monitoring Accutane, said that Roche's program to limit use and pregnancy exposures has not been successful and that the only way to prevent pregnancy exposures is to "eliminate...use in women of childbearing age." Health Research Group Director Sidney Wolfe, MD, reiterated the group's position that distribution of the drug should be limited and threatened "going to the U.S. Congress to force the issue."

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