Ru-486 Case Study

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Groupe Roussel-Uclaf has announced its intention to distribute RU-486 in the US. There are only two modes of legitimate entry to the market: drug approval through FDA or qualification under an importation exemption for “life-saving” medications. If made available in the US, RU-486 will make abortion more accessible, a trend which runs counter to the Republican’s pro-life platform and the administration’s desire to eliminate use of federal monies for abortion-related activities. A Republican appointee, FDA Commissioner Young must prevent RU-486 from entering the market. He can do so by employing regulatory tactics such as exercising authority, traditional bureaucratic “red tape,” and anti-abortion regulations; codifying these decisions, hence…show more content…
Wade, abortion has been a hot-button issue of social and political dissension in the US. President Reagan’s steps to thwart abortion access and curb the reach of Roe include barring federal funding of abortion-related research, furthering the Hyde amendment that banned Medicaid funds from being used for abortions, and eliminating funding to NGOs that provided abortion counseling or services. The fate of RU-486 will be decided within the FDA, an independent governmental agency headed by a political appointee who holds significant decision-making power. The nature of the bureaucratic system allows for different tactics than a traditional partisan fight. There are several key actors who can affect the future of RU-486 in the US. President Reagan and his administration, Commissioner Young, and pro-life interest groups do not want RU-486 to be distributed in the US. Pro-choice groups, Roussel and other pharmaceutical companies want RU-486 to be present in the US market. In the long term, the Republican administration and its pro-life allies will want to solidify the FDA’s position on RU-486 making it difficult for opponents to infiltrate the agency’s bureaucratic structure and allow possible approval of the drug. Opponents will want to keep the FDA structure more open, hoping to gain an opportunity for policy change with a shift in political…show more content…
Young has already taken an integral first step by using his FDA authority and codifying the non-applicability of the “life-threatening conditions” exemption to RU-486. The proclamation was issued by a professional member of the FDA, not a political appointee, giving it further legitimacy and protecting it from future political power shifts. By incorporating this into official FDA rules there is precedence for preventing future importation of RU-486 or other abortion related
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