RU 486 in France and England: corporate ethics and compulsory licensing
Article Abstract:
The French and British governments were fully involved in the process of licensing RU 486 and putting the drug on the market in their countries. The US experience has been marked by so much government hostility to abortion that Roussel-Uclaf has decided to defer indefinitely applying for a US license and not to make the drug available for research. The company's stance raises serious ethical questions since it endangers public health and denies US citizens the benefit of scientific innovations. Compulsory licensing may be necessary to afford Americans the benefit of this method of abortion.
Publication Name: Law, Medicine & Health Care
Subject: Law
ISSN: 0277-8459
Year: 1992
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Benten v. Kessler: the RU 486 import case
Article Abstract:
The Benten v Kessler case challenged the exclusion of RU 486 from Food and Drug Administration (FDA) regulations permitting the importation of drugs the FDA has not yet approved for personal use. While Benten was not successful in such importation, the US District Court for New York strongly condemned the import ban. Justice Stevens' dissenting opinion at the Supreme Court level held that women have a constitutional right to abortion and to choosing the method of abortion. He also stated that the 'undue burden' standard requires the court to balance the burden against the state's interest.
Publication Name: Law, Medicine & Health Care
Subject: Law
ISSN: 0277-8459
Year: 1992
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RU 486, the FDA and free enterprise
Article Abstract:
The issues hampering FDA approval for RU 486 are political rather than legal. The articles on RU 486 in medical journals provide ample evidence of safety and efficacy. Drug companies developing drugs other than contraceptives and abortifacients do not seem to be constrained by fears of products liability, and harboring these fears with regard to gynecological drugs may exemplify a sexist, over-protective view of products liability. The only real impediment to the introduction of RU 486 in the US is the lack of a willing sponsor.
Publication Name: Law, Medicine & Health Care
Subject: Law
ISSN: 0277-8459
Year: 1992
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