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  • Title: Introduction of RU 486 in the USA: obstacles and opportunities.
    Author: Thoss E.
    Journal: Plan Parent Eur; 1993 Oct; 22(3):18-9. PubMed ID: 12288950.
    Abstract:
    On January 22, 1993, the 20th anniversary of the US Supreme Court decision Roe v. Wade, President Clinton reversed an oppressive rule relating to abortion imposed by former Presidents Reagan and Bush. In addition, the president directed the US Food and Drug Administration (FDA) to rescind the restriction on RU-486 and to promote its testing, licensing, and manufacturing in the US. On February 24 a meeting was held between the FDA commissioner and the president of Roussel-Uclaf. The Reproductive Health Technologies Project's own meeting was on April 14, 1993, to review the outlook for introduction of RU-486 in the USA. Roussel-Uclaf stated that: the company was ready to apply for FDA approval; clear guidelines should be developed on how the compound should be used; optimal care with regard to cases with complications should be guaranteed; and the method should be strictly medicalized. The Population Council has a contract with Roussel-Uclaf to conduct trials on RU-486 in the US. Meetings between the FDA, Hoechst AG, and the Population Council took place on April 20, 1993. Roussel-Uclaf agreed to license the production of RU-486 and the technology for making it to the Population Council. This agreement will take probably as much as 2 years. The Population Council will begin clinical trials for at least 2000 women shortly. The Population Council will begin putting together the documentation for a new drug application to be submitted to the FDA. Roussel-Uclaf will supply the Population Council with its toxicological, chemical, and clinical data as soon as possible. The Population Council will be responsible for finding a US manufacturer to produce RU-486. Several companies have expressed an interest already. In addition there are issues to be settled regarding the provision of services and the training of providers.
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