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Executive Summary

ROCHE SUGGESTING ACCUTANE BLISTER PACKS as one option for addressing FDA concerns over use of the drug by pregnant women or by women of childbearing age who do not take adequate precautions against pregnancy, the company said. The firm explained that blister packs might provide better assurance that consumers see the warning statements than the currently used packaging because the information would not be physically separate from the product. The blister packs also would provide only a two week supply, whereas the current unit-of-use packages provide a month's supply of Accutane. Roche is evaluating new options for warnings in light of a Feb. 11 report by FDA's Office of Epidemiology and Biostatistics recommending that the drug be removed from the market. The firm will present its plans for the blister pack, as well as additional physician label warnings and a new professional educational program to be undertaken with the Academy of Dermatology, to FDA's Dermatologic Drugs Advisory Committee on April 26. According to a prepared agenda for the meeting, FDA will ask the committee to evaluate whether Accutane (isotretinoin) should be removed from the market, and if not, to recommend how physician or patient labeling might be revised. The advisory committee will also be asked to consider other options beyond labeling changes. A list of questions to the committee specifically asks the group to consider three other options: (1) "Additional publicity, education?" (2) "Require patients to sign a statement acknowledging that they understand the serious adverse effects of the drug?" and (3) "Restrict distribution (voluntary on part of drug manufacturers)." The FDA Office of Epidemiology and Biostatistics report was sent out to the advisory committee members and Roche for review prior to the meeting. The report estimates, based on published data and information from both Roche and the National Disease and Therapeutic Index, that between 270,000 and 390,000 women of child bearing age received the drug between its market introduction in 1982 and 1986. The report asserts that only 0.4% to 3.3% of those women met the approved label indication for "severe, recalcitrant cystic acne unresponsive to conventional therapy including systemic antibiotics." The report also estimates the probable exposure to pregnant women and resulting birth defects and abortions based on an extrapolation of data from the Michigan Medicaid data base. Based on 55 pregnancy exposures to 928 women of childbearing age in the data base from 1982 to 1986, FDA projects that 16,000 to 23,000 pregnancy exposures may have occurred in the U.S. during that time period with a resulting 900 to 1,300 birth defects. FDA's cumulative adverse reaction data base currently contains reports of 62 birth defects thought to be associated with Accutane treatment. The report concludes that pregnant women continue to be exposed to Accutane despite extensive efforts by the company to alert physicians, consumers and pharmacists to the drug's dangers in that population. Therefore "active consideration" should be given to "removal of Accutane from the market," the report states. Roche, in a written response to the study, maintains that the extrapolation of Medicaid data is scientifically "flawed", and that the estimates of risk and pregnancy exposures are inaccurate. The firm also asserts that "the number of reported congenital malformations and pregnancies associated with Accutane therapy appears to have declined since 1983" after the drug was relabeled and an educational campaign undertaken to alert professionals and consumers to the risks of use during pregnancy.

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