Medical Abortion for All: Mifepristone Use in America

In the US, the abortion debate, as it is currently framed, stems from the complex interplay of religion, shifting societal perceptions on women’s reproductive rights, and deliberate political maneuvering by the state. Given the constant onslaught on reproductive choice, it seems difficult to imagine a time when abortion was considered an uncontroversial, even mundane event in a woman’s life. Despite the legality of abortion, women in many parts of the U.S. still find it extremely difficult to navigate the many legislative and institutional barriers put in place to discourage abortion. This is what makes the promise of medical abortion as a non-surgical abortion alternative so potent.

Mifepristone, or “RU 486″ as it is commonly known, first debuted in France as an abortifacient which provided women with a non-surgical abortion alternative. It was synthesized in the laboratory of Roussel Uclaf in 1980, a company primarily known in France as a leading steroids producer[i]. After several clinical trials in France, Switzerland, and other European countries were undertaken to establish the efficacy and safety of the drug, RU 486 was approved by the French Ministry of Health for public use in 1988 and became commercially available in 1990 [ii]. Though initial opposition to RU 486 in France was headed by the Catholic Church, the resulting boycotts and marches did not gain much traction with the general public[iii] (Lader, 1991, p. 39). However despite the lack of significant resistance within France, Roussel Uclaf actually decided to take the pill off the market, with one of the company’s directors Arlette Geslin stating that they “didn’t want to get into a moral debate.” [iv] It was the concerted and united efforts of the general public, including doctors and most of France’s political parties, that pushed the French Health Minister Claude Evin to put the pill back on the market, calling RU 486 the “moral property of women” [v]

The company’s internal ideological schism was a principal reason for its often conflicted stance towards RU 486. Author Carolyn De Costa writes that “Roussel refused permission to file applications in many other European countries…women were denied access to the drug until the late 1990s, when Roussel no longer held the patent” [vi]. The company’s attempts to divest from its ground-breaking product were most noticeable when Roussel shut down any further RU 486 research shortly in the US after the Bush Administration blocked the drug from being imported. Roussel had no interest in pursuing the US market, anticipating that the resistance to RU 486 would be much stronger than in it had been in France[vii]. Finally, the Clinton administration reversed the ban and after gaining FDA approval, the pill was finally available to American women in 2000 via the Danco company[viii].

However, since its legalization in 2000, RU 486 has been subject to various FDA restrictions, political maneuvering, and intense pressure from a plethora of groups to be banned entirely. Mifepristone’s FDA approval was based on the success of the drug in two French trials and one large scale US trial conducted by the Population Council, as well as post-marketing safety data from a database of 620,000 women[ix]. Mifepristone was only approved by the FDA under subsection H due to the potential for adverse side effects such as excessive bleeding[x]. Thus, women can only receive prescriptions for mifepristone through doctors who are licensed to perform blood transfusions as well as a surgical abortion if necessary.

Researchers Joffe and Weitz take special exception to the requirement that mifepristone can only be dispensed by doctors qualified to perform blood transfusions and surgical abortions, given that only 4 to 5 % of women who used the drug had complications requiring such services[xi]. Joffe and Weitz state that “in the approximately 6000 patients who had mifepristone abortions in the two US trials, no injuries or complications were reported; a few patients needed blood transfusions after the mifepristone regime[xii].” Despite these promising statistics, mifepristone has been under further attack by citizens and activist groups on both sides of the political spectrum.

The pro-life group Americans United for Life filed a citizen’s petition to the FDA citing concerns that RU 486 was being approved without careful review of the drug’s effects[xiii]. The petition cited such reasons as “incidence of complications may be underestimated” and “poor patience compliance and follow-up” as justification for an FDA ban on mifepristone[xiv]. The petition further claimed that RU 486’s efficacy decreased in later stages of pregnancy. However, this objection does not seem valid given the pill’s intended use in ending pregnancies in the early stages of gestation or within the first 7 to 9 weeks[xv].

The FDA’s added restrictions on mifepristone only complicate existing issues of abortion access such as parental consent laws and mandatory waiting periods which can prove onerous and expensive, especially for low-income women with dependents[xvi]. These guidelines must be analyzed in contrast to the standard review of most FDA drugs because, as Village Voice writer Sharon Lerner states plainly, “to understand how extreme these restrictions are, realize that—with very few exceptions—the FDA has no say as to who gets to prescribe drugs. The agency doesn’t require doctors to be able to do bypass surgery in order to prescribe heart medications.”[xvii]

However, in spite of the FDA restrictions, RU 486 still has far-reaching implications for women and the broader reproductive rights movement. With RU 486, women can avoid the stigma and inconvenience of waiting till a later stage of pregnancy to have a surgical abortion. Some French women commented on how taking RU 486 felt less clinical and “more natural” than a surgical abortion[xviii]. Others claimed that it made them feel less guilty and RU 486 felt more like a morning-after pill than an abortion pill[xix]. Most importantly, mifepristone precludes the interference of medical personnel and the threat of harassment from anti-abortion protesters. As Sharon Lerner muses, “Imagine. Instead of facing a phalanx of picketers and being called a murderer, a woman could simply go to her regular doctor’s office and, depending on the specific regimen the FDA approves, even abort at home.”[xx]

RU 486 could also potentially alleviate the critical issue of abortion access that plagues many American women. The Alan Guttmacher Institute found that in 2008, 88% of all US counties did not have an abortion provider[xxi]. Many researchers also assert that given the stated reluctance of many gynecologists and providers to perform later term abortions, RU 486 allows women the option of managing their own pregnancies. As Joffe and Weitz assert “‘performing an abortion’’ would no longer have to depend on surgical training, and in theory, any clinician with prescription writing privileges could become an abortion provider.[xxii]”

There are some promising indications that mifepristone use is on the rise in the U.S. Researcher Eric Schaff notes that far from being phased out as an alternative to surgical abortion, mifepristone abortions accounted for 14% of all abortions and 21% of early abortions in 2007[xxiii]. However, the mainstream adoption of mifepristone use in the US is still hampered by other factors, namely the lack of a monitoring mechanism and the low geographic availability of mifepristone providers. Mifepristone is currently manufactured and distributed by the Danco Company under the commercial name Mifeprex, and is only available for distribution via licensed physicians. Furthermore as Richard Hausknech, the medical director of Danco, stated bluntly “The company that’s doing this is tiny. It’s literally a mom-and-pop store[xxiv]“. Joffe and Weitz add, “the security issues surrounding this enterprise are so great that Danco operates out of an office with an unlisted phone, and with the name of another company on its door.”[xxv]

Given the unique scrutiny abortion providers face, it will be increasingly difficult for women to obtain a medical abortion via mifepristone if the FDA restrictions are not relaxed. Though they have often stated otherwise, it is clear that the political and health entities legislating the amount of access American women have to RU 486 are not immune to the larger abortion debate. The often unreasonable standards placed on contraceptive and fertility controlling drugs are disingenuously framed as necessary safety checks for women, despite mounting evidence that the risks associated with mifepristone are often grossly overstated. As Sharon Lerner puts it; “the proposed restrictions threaten to destroy precisely the most exciting potential of RU-486: to weave abortion into the normal fabric of the medical system.[xxvi]” Perhaps removing the institutional obstacles placed on mifepristone use holds the key to achieving this goal.

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[i] De, Costa C. Ru 486. Salisbury, Qld: Boolarong Press, 2007. Print.

[ii] De Costa, 2007 p. 29

[iii] Lader, L. (1991). RU 486: The pill that could end the abortion wars and why American women don’t have it. Reading, Mass: Addison-Wesley Pub. Co.

[iv] Lader, 1991, p. 50

[v] De Costa, 2007, p. 30

[vi] De Costa, 2007, p. 31)

[vii] Lader, 1991, p. 108)

[viii] De Costa, 2007, p. 33

[ix] Food and Drug Administration. (2006). Testimony on RU 486: Demonstrating a Low Standard

for Women’s Health? Retreived from

http://web.archive.org/web/20060927090806/http://www.fda.gov/ola/2006/mifepristone0517.html

[x] FDA, 2006

[xi] Joffe, C., & Weitz, T. A. (January 01, 2003). Normalizing the exceptional: incorporating the

“abortion pill” into mainstream medicine. Social Science and Medicine, 56, 12, 2353-2366.

[xii] Joffe and Weitz, 2003, p. 2361

[xiii] Cunningham, P.C., McCoy, L., & Forsythe, C.D. (1995). Citizen’s petition to the food and drug administration. Americans United for Life. (1995). Retrieved from http://www.fnsa.org/v1n3/americans.html

[xiv] Cunningham, McCoy, & Forsythe, 1995

[xv] Joffe and Weitz, 2003

[xvi] AGI. (2000). Facts in brief: Induced abortion (January), (www). The Alan Guttmacher Institute

(AGI). Available at http://www.agi-usa.org/pubs/fb_induced_abortion.html [January 2011]

[xvii] Lerner, S. (2000, August 29). RU Pissed off Yet. Village Voice. Retrieved from

http://www.villagevoice.com/2000-08-29/news/ru-pissed-off-yet/

[xviii] Lader, 1991, p. 53

[xix] Lerner, 2000

[xx] Lerner, 2000

[xxi] AGI, 2011

[xxii] Joffe and Weitz, 2003, p. 3

[xxiii] Schaff, E. A. (January 01, 2010). Mifepristone: ten years later. Contraception, 81, 1, 1-7.

[xxiv] De Costa, 2007, p. 33

[xxv] Joffe and Weitz, 2003, p. 2361

[xxvi] Lerner, 2000