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  • Title: RU-486: legal and policy issues confronting the Food and Drug Administration.
    Author: Muhl C.
    Journal: J Leg Med; 1993 Jun; 14(2):319-47. PubMed ID: 8340714.
    Abstract:
    The debate surrounding access to RU-486 in the US resurfaced in July 1992 when a pregnant California Resident attempted to challenge the Food and Drug Administration (FDA) import ban by going through customs at Kennedy International Airport with 12 prescription RU-486 pills she obtained in England. The pills were confiscated and the US Supreme Court denied the woman's request to recover the pills by a 7-2 vote. In 1993, on the 20th anniversary of the Roe v Wade abortion decision, President Clinton instructed the FDA to assess the real health and safety risks of the drug and rescind the ban if politics turns out to be the central issue. FDA has no criteria for measuring acceptable levels of safety, and drug approval is a lengthy process. Moreover, clinical trials are not initiated until a pharmaceutical company applies for FDA approval, which Roussel-Uclaf, RU-486's developer, has not done despite a wealth of safety and effectiveness data amassed in Europe. In fact, fearing a consumer boycott of its other products by US anti-abortion groups, Roussel-Uclaf has limited American researchers' access to RU-486. Despite the pro-choice climate of the Clinton Administration, it is unlikely that RU-486 will be available any time soon to US women, and physicians are concerned that a black market for the drug will emerge. This likelihood has serious consequences for people with Cushing's disease, nonmalignant brain tumors, breast cancer, and other medical conditions that may be responsive to RU-486. Given the experience with the introduction of oral contraceptives, marketed before long-term health consequences had been sufficiently explored, it is essential that FDA researchers investigate the impact of RU-486 on future children, future fertility, its interaction with other medications and contraceptives, and its effects on other bodily systems. At the same time, any risk-benefit assessment must be based on scientific merit, and access to Ru-486 cannot be denied on political or moral grounds.
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