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Executive Summary

ROCHE WILL DISTRIBUTE ACCUTANE PREGNANCY PREVENTION KITS to all dermatologists and other Accutane (isotretinoin) prescribers nationwide starting Sept. 19. The kits are part of Roche's Pregnancy Prevention Program, which also includes revised labeling, blister packs and educational programs for the anti-acne drug. Details of the program were discussed at a Sept. 7 Roche press conference in New York City. The Pregnancy Prevention Program kits, designed to aid physicians in patient selection and counseling, will include: a patient qualification checklist; a patient information brochure on Accutane; information on a toll-free telephone recording that reiterates teratogenic warnings printed in the brochure and packaging; a patient information booklet on birth control; a patient self-evaluation form; and a patient consent form. Along with the kit, a videotape has been prepared for use by the sales force, which explains how to maximize use of the kit. Roche expects the program to cost between $ 3 mil. and $ 5 mil. annually. U.S. sales of Accutane are approximately $ 50 mil. annually. The plan was initially outlined by the firm at an April 29 meeting of FDA's Dermatologic Drugs Advisory Committee. The meeting was triggered by a Feb. 11 agency report recommending that Accutane be removed from the market because of the continuing incidence of pregnancy exposures and Accutane-associated birth defects. The committee unanimously agreed that Accutane should remain on the market and, by a narrow four-to-three vote, that distribution of the product should be limited ("The Pink Sheet" May 2, p. 14). Under the plan's Patient Counseling Referral Program, should a prescribing physician decide to refer a patient to a consultant for contraceptive counseling and the initial pregnancy test, Roche "will provide direct reimbursement to the consultant and to the clinical laboratory that performs the patient's initial pregnancy test," the firm said. Roche received approval of its revised Accutane physician package insert and for the use of the patient consent form on Aug. 26. Changes in the physician labeling include enlargement of both the print size and the content of the boxed contraindication and warnings section, and the addition of an "avoid-pregnancy" symbol. The contraindication section now includes "six specific criteria that women must meet to receive a prescription for Accutane," according to Roche. Roche noted that it mailed out a "Dear Doctor" letter on Sept. 6 to all dermatologists, informing them of Accutane's labeling changes. The company will also send the letter to all other physicians and pharmacists during the week of Sept. 11. The company is placing educational advertisements on proper Accutane prescribing in publications directed at dermatologists and in medical journals read by non-dermatologists. The ad targeted at dermatologists will run starting in October in the Journal of American Academy of Dermatologists, Skin and Allergy News, and the Archives of Dermatology. The other ad will likely appear in the medical publications Patient Care, Hospital Practice, and Medical Economics during late September. Roche pointed out that FDA is still reviewing two aspects of the program -- the blister packaging and a protocol for a surveillance study. "Within approximately two months of approval, Accutane capsules will be marketed only in blister packages of 10 capsules," Roche said. The new packaging "is designed to assure that the patient sees the pregnancy warning every time she takes a capsule," the company added. The surveillance study will "examine the extent of use of Accutane among women of childbearing potential, their awareness of the pregnancy warning, and the outcomes of any pregnancies that might occur while on Accutane." The study will conducted by the Slone Epidemiology Unit, an independent research group at the Boston University School of Public Health.

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