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INTRODUCTION
Assessing Medical Abortion in the US:
One Year After the FDA Approval
of Mifepristone
Jean Reith Schroedel, Claremont Graduate University
BACKGROUND
In 1980 a team of French scientists, led by Dr. Étienne-Émile Baulieu,
discovered that a combination of drugs could be used to non-surgically
terminate early pregnancies. They found that the first drug, mifepristone (initially named RU 486), which is given through an injection,
inhibits the effectiveness of progesterone and weakens the embryo’s attachment to the uterine wall. Two days later, the woman takes the second drug, misoprostol, which brings on uterine contractions that expel
the fetal tissue. During the first eight weeks of a pregnancy, the drugs
are effective 92-96% of the time (Population Council 2000; Schaff et al.
2000).1 Because surgical abortions had been the only safe and legal
means of terminating an unwanted pregnancy for more than one hundred years, the discovery of an effective means of drug-induced abortions was viewed by many as a potentially revolutionary development.
Women & Politics, Vol. 24(3) 2002
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In 1988, France became the first country to approve the use of
mifepristone as an abortifacient. Britain, China, Sweden, Germany,
Austria, Belgium, Denmark, Finland, Greece, Luxembourg, the Netherlands, Spain, Switzerland, and Israel subsequently approved mifepristone
(Population Council 2000). More than 600,000 women in Europe have
used the drug, as have millions in Asia (Population Council 2000;
Schaff et al. 2000).2 Elizabeth Crighton and Martina Ebert offer a detailed exploration of the politics of legalization in different European
countries (this volume).
Efforts to bring the drug to the United States, however, were stymied
by a coalition of anti-abortion groups, working in conjunction with right
to life politicians. In 1987, the coalition held a conference in New Orleans
where they developed strategies to block Food and Drug Administration
(FDA) approval and, the following year, they formed a registered Washington, DC lobbying group, whose sole purpose was to keep the drug out
of the United States (Charo 1991). Feminist groups, primarily under the
leadership of the Feminist Majority Foundation, started a counter-mobilization.
The fact that patent rights to mifepristone were held by a private
company, Roussel Uclaf, presented feminists with a challenge. Social
movements typically direct their action toward governmental entities.
In this case, they had to neutralize a company’s fears of an economic
boycott from anti-abortion groups and convince them that there was
widespread support for the drug in the United States. Jennifer Jackman
(this volume) provides the first definitive account of the strategies
adopted by feminist groups to convince Roussel Uclaf to transfer patent
rights to the Population Council, thereby opening up the possibility of
legalization in the United States. Tanya Buhler Corbin and I analyze the
struggle over mifepristone within Congress, the White House, and the
FDA during different administrations and under different partisan configurations (this volume).
THE POTENTIAL TO REVOLUTIONIZE
ABORTION PRACTICES
The potential market in the United States is far larger than exists in
Europe. Each year, 670,000 women in the United States have surgical
abortions during the first two months of their pregnancies, the time period when RU 486 can be used (Koonin et al. 1999). Given the high levels of patient satisfaction with medical abortions, researchers often
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suggested that many women, if given the option, would choose medical
over surgical abortions (Bugalho et al. 2000).3 In the late 1990s, the
Kaiser Family Foundation conducted a survey of women’s health care
providers to find out how willing they would be to use mifepristone.
Forty-four percent of gynecologists and 31% of family practice physicians said they were “somewhat likely” or “very likely” to prescribe
mifepristone to patients seeking abortions (Kaiser Family Foundation
2000).
Activists on both sides of the abortion debate believed that mifepristone would transform the debate by making it a private decision between doctor and patient, rather than a procedure involving a trip to an
abortion clinic, where women who choose to end a pregnancy and the
doctors who perform abortions are readily identifiable by anti-abortion
activists (Lader 1991). On a symbolic level, early term medical abortions potentially pose an even greater threat to the right to life movement because they subvert their argument that the “unborn child” is a
full human being. Instead of being visually represented by a nearly fullterm fetus, complete with recognizable fingers and toes, there is an embryo with no recognizably human features (Robertson 1994). As such,
both sides of the abortion debate have a big stake in decisions about the
drug.
MINIMAL SHORT-TERM EFFECTS
Contrary to expectations, the FDA’s September 28, 2000 approval of
mifepristone has not transformed abortion practices and politics in the
United States. One year later, the drug’s impact has been far from revolutionary.4 Mifepristone is primarily being offered as an option by physicians who already provide surgical abortions rather than expanding
the number of providers. According to the National Abortion Federation, the professional association of abortion providers, roughly half of
its members offer medical abortions as an option to their patients.
Planned Parenthood Federation of America also estimates that half of
its affiliates provide the drug (Kaiser Family Foundation 2001). Abortion providers, however, are a relatively small proportion of medical
practitioners.5 A new national Kaiser Family Foundation survey of 790
women’s health care providers puts these figures into perspective. Only
about 6% of gynecologists and 1% of general practice physicians reported that they had provided their patients with mifepristone-induced
abortions (Kaiser Family Foundation 2001).6
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Although the number of physicians offering mifepristone will probably increase in the next year, it is unlikely to expand far beyond those already offering surgical abortions. When asked whether they were likely
to begin offering the drug in the next year, 16% of gynecologists and
7% of the general practice physicians indicated that they would (Kaiser
Family Foundation 2001). However, 40% of gynecologists and 37% of
general practice physicians said they do not offer mifepristone because
they “personally oppose” abortion. Among physicians not currently offering mifepristone for reasons other than their personal opposition to
abortion, 30% of gynecologists and 21% of general practice physicians
cited concerns about protest or violence as an important factor in their
decision (Kaiser Family Foundation 2001). Many also mentioned a lack
of patient demand, office space not set up to offer medical abortions,
lack of interest in performing abortions, and political controversy surrounding abortion (Kaiser Family Foundation 2001).
LONG-TERM EFFECTS ARE UNCLEAR
Although it is clear that medical abortion is not going to revolutionize
abortion practices in the short term, it is too early to assess its impact over
time. Awareness of the drug is still very low. A 1997 public opinion survey found that only 43% of women had ever heard of mifepristone (Kaiser Family Foundation 2000). A more in-depth analysis of the factors
affecting public opinion about medical abortion are provided by Clyde
Wilcox and Julia Riches (this volume), who examine trends across time
using public opinion data from 1989 and 2000. Among those who have
heard of the drug, responses are roughly split between those favoring
and those opposing it. However, because few people know much about
the drug, Wilcox and Riches believe public opinion is still malleable.
Although it is difficult to predict how opinion will change as awareness
of medical abortion increases, Wilcox and Riches note that the public’s
initial reaction to the “morning after” pill was quite negative but that
changed as people gained greater knowledge and its availability increased.7 A similar point is made by Janet Farrell Brodie (this volume),
who points out that “[n]othing related to abortion has fixed, immutable
meaning.” She argues that as early term medical abortions become
more widely available in the United States, the cultural meaning of
abortion may come to more closely resemble that held by women in the
nineteenth century when medical abortions were common and there
was little stigma associated with having an early-term abortion.
Jean Reith Schroedel
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THE CONTINUING BATTLE OVER ACCESS
Right to life groups have continued their campaign against mifepristone. Although disappointed that the new Bush administration did not
immediately reverse the FDA’s approval, these groups were cheered by
an announcement from Health and Human Services Secretary Tommy
Thompson that the government will apply the same restrictions on
Medicaid funding for medical abortions as they do on surgical abortions.8 Thompson also said that state regulations and laws restricting
surgical abortions could be applied to medical abortions as well (Feminist Daily News Wire 2001). State legislatures have adopted a wide
range of laws that limit access to abortion, such as parental involvement
laws that restrict minors’ access, mandatory waiting period laws, informed consent requirements, and physician-only laws.9 Some states
mandate a physician or pathologist examine fetal tissue after an abortion, while others have specific requirements about the disposal of the
fetal tissue. In order to comply with these laws, the woman must collect
and bring the expelled fetal tissue to the physician, who would then
have to ensure that the examination and disposal requirements are met
(Jones and Heller 2000).
Targeted Regulation of Abortion Providers (TRAP) laws, which impose very detailed and hard to satisfy requirements on abortion providers, pose the greatest obstacle to increased abortion access. In the
mid-1990s South Carolina10 and Mississippi became the first states to
pass laws that require abortion providers meet very stringent regulations that are not applied to other medical providers who perform similar or even riskier medical procedures. There is some variance among
the twenty states with TRAP laws, but most require expensive modifications to clinic buildings or doctors’ offices or mandate the purchase of
expensive and unneeded medical equipment.
Although proponents of TRAP laws claim that they are needed to
protect women’s safety, Dr. David Grimes, the former head of the Center for Disease Control branch that oversees abortion safety, labels
TRAP laws the “antithesis” of good medical practice. “I can say with
confidence that these regulations do not have a single positive impact
on women’s health. Having published on every hemorrhaged abortion
death in the United States, I can assure you that not a single one was
caused by a door width” (Yeoman 2001, 50). Instead, many describe
TRAP laws as a “stealth attack” on women’s right to choose–one that
will force some clinics to cease operating or raise the cost of abortions
beyond the reach of low income women. Clinic operators believe that
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conforming with these new regulations could increase the cost of each
abortion by as much as $370 (Center for Reproductive Law and Policy
2001b).
Abortion opponents also still have not given up on attempts to ban
mifepristone. Although Health and Human Services Secretary Tommy
Thompson has not yet tried to reverse the FDA approval, he has stated
several times that there might be safety concerns about the drug, which
could lead to it being re-evaluated (Associated Press 2001). Two bills
restricting access to mifepristone have been introduced into the 107th
Congress (2001-2002). David Vitter (R-LA), a recipient of campaign
contributions from the American Right to Life Political Action Committee, sponsored “The RU 486 Patient Health and Safety Protection
Act” that would mandate the FDA impose very stringent restrictions on
the use of mifepristone (H.R. 482).11 In the Senate, Tim Hutchinson
(R-AR) introduced an identical bill (S. 251). As of this writing, neither
of these bills had been reported out of committee, and given that identical bills were never reported out in the previous Congress, it is likely
that both will die in committee.
Three states have passed anti-mifepristone legislation.12 The most innovative is a Michigan law prohibiting the state-mandated abortion literature (which women are required to read prior to getting an abortion)
from including information about any procedure that uses a drug that
has not been specifically approved for use in an abortion. Because
misoprostol, the second drug used in medical abortions, was approved
for treating ulcers and not as an abortifacient, the law made all medical
abortions in the state illegal. After a challenge from the Center for Reproductive Law and Policy, the state entered into a settlement that acknowledged that misoprostol has been approved by the FDA for use
with mifepristone in medical abortions. They also agreed to allow
physicians to produce their own abortion literature if there are no
state-approved materials that cover the particular type of abortion being
performed (Center for Reproductive Law and Policy 2001a). Georgia
passed a law that added mifepristone to the official list of controlled
substances along with illegal narcotics and prescription drugs (Official
Code of Georgia Annotated at 16-13-71). As a practical matter, inclusion on the list of “dangerous drugs” does not decrease mifepristone’s
availability since it already is a prescription drug, but it does create a
negative perception of it. Iowa enacted a law that prohibited state funds
from being used by its university system to pay for abortions. The statute specifically prohibited the use of mifepristone by university health
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centers (Iowa SF 535). At least five more states are considering legislation to restrict access to mifepristone.13
Pro-choice groups have been forced to spend much of their time
combating these state and national campaigns to restrict access. The
Center for Reproductive Law and Policy, the National Abortion Federation, and the National Abortion and Reproductive Rights Action
League have been involved in lobbying at the state and national level, as
well as in legal actions to preserve access. Pro-choice legislators in California succeeded in passing a law to encourage further research into the
effectiveness of mifepristone as treatment for breast and ovarian cancer,
meningioma, endometriosis, Cushing’s syndrome, osteoporosis, diabetes, and AIDS (California Health & Safety Code at 439.905). After discovering that only Yale’s student health center prescribed mifepristone
for abortions, the Feminist Majority Foundation launched a campaign
called “Prescribe Choice” to increase the access on campuses (Feminist
Majority Foundation 2001). Organizers from the Foundation, in conjunction with student feminist groups, have begun to lay the groundwork for a nationwide grassroots effort to make mifepristone available
in student health centers.
CONCLUSION
As we have shown, expectations that FDA approval of mifepristone
would revolutionize abortion in the United States are not going to be
fulfilled in the short run. Early indications are that the right to life movement will wage a national campaign against medical abortions and that
any gains in access will occur incrementally and after a protracted
struggle. Because the drug has only been available for roughly six
months, it is still too early to determine which side will prevail. Based
upon the dramatic increase in support for the “morning after” pill after
the public became aware of its safety and efficacy, there is reason to believe that the same could occur as public knowledge about mifepristone
increases.
A major impediment to increasing public awareness is its limited
availability. Until that changes, there will be only minimal word of
mouth knowledge about the drug. Even though large numbers of gynecologists and family practice physicians had previously indicated an interest in offering mifepristone to their patients, few have chosen to do so
thus far. Responses to survey questions about why they do not make
mifepristone available to their patients indicate that anti-abortion
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groups have succeeded in making physicians wary of the financial and
psychological costs of offering it. Among those not personally opposed
to abortion, reasons for not offering the drug include fears of harassment and violent protests, discomfort with the political controversy surrounding it, and the expenses associated with meeting state regulatory
requirements. When added to a lack of patient demand, these barriers
are enough to deter most gynecologists and family practice physicians.
At this time, the most protracted battles over mifepristone are occurring
at the state rather than the national level. Even though the Bush administration is distinctly anti-choice, congressional support for mifepristone has
limited its effectiveness. The situation in the states, however, is quite
different. In only six states can both the governor and a majority of state
legislators be classified as “pro-choice.” In eleven states, the right to life
position is supported by both the governor and a majority of state legislators and the rest are split (National Abortion and Reproductive Rights
Action League 2001).
Although only a handful of states have thus far passed anti-mifepristone
laws, many have passed TRAP laws that require abortion providers (both
medical and surgical) to abide by stringent and costly regulations. These
laws, and the continuing harassment of physicians offering any type of
abortion, appear to be the main reasons why family practice physicians and
gynecologists, who had previously expressed interest in mifepristone, have
shied away from offering it. The Kaiser Family Foundation survey, however, indicates that increased patient demand could induce them to reconsider. These findings indicate that feminist groups will have to wage a
long and protracted struggle–in the nations’ courtrooms, state legislatures, and in the media–if they want medical abortion to become a viable alternative for women seeking to terminate an early-term abortion.
Otherwise, the FDA’s approval will be rendered meaningless.
NOTES
1. Without mifepristone, a single dose of misoprostol has been found to induce
early-term abortions in up to 87% of the cases (Bugalho et al. 2000).
2. Mifepristone also has shown potential in treating a variety of illnesses:
meningiomas (brain tumors), endometriosis, uterine fibroid tumors, Alzheimer’s, HIV,
depression, some types of breast cancer, and Cushing’s Syndrome. The drug also may
have the potential to treat kidney disease, glaucoma, and ectopic pregnancies, but
needs to be tested (Caplan 1992).
3. One cross-national study found that among women who had medical abortions,
the vast majority would choose that option again if they needed an abortion. The per-
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centages from the countries studied are as follows: Britain 88%, United States 92%,
and Canada 83% (National Abortion Federation 2000).
4. It took about six months after the FDA approval for the drug to be made available. Over the past six months, Planned Parenthood Federation affiliates have provided
mifepristone-induced abortions to 5,200 patients. Their success rate was 99% and none
of the women experienced adverse effects (Roan 2001).
5. Only 27% of gynecologists report having performed surgical abortions in the
past five years and only 1% of general practice physicians perform abortions (Kaiser
Family Foundation 2001).
6. In the United States, mifepristone is manufactured by Danco Laboratories and is
marketed as Mifeprex.
7. “Morning after” pills are oral contraceptives that halt conception if taken within
72 hours of intercourse. These drugs are also referred to as “emergency contraception”
and depending upon the point in a menstrual cycle, they halt or delay ovulation or alter
the lining of the uterus to prevent the implantation of a fertilized egg.
8. Since 1976 a version of the Hyde Amendment, named after its primary sponsor
Representative Henry Hyde (R-IL), has been either attached to every appropriations
bill that covers Medicaid funding or passed as a joint resolution of the House and Senate. Early versions of the Amendment prohibited the use of federal Medicaid funding
for abortions except when the life of the woman is at risk. More recent versions have included exceptions for rape and incest victims. Twenty-six states and the District of Columbia prohibit state funds from being used to pay for abortions unless the life of the
woman is endangered or the pregnancy is the result of rape or incest (National Abortion and Reproductive Rights Action League 2001).
9. As of January 2001, 42 states had laws requiring parental involvement in the decision by a minor to have an abortion. These states are roughly split between those requiring parental consent and those that require parental notification. Nineteen states
have laws mandating a waiting period, usually 24 hours, before a woman can obtain an
abortion. Thirty states have informed consent laws, many of which require women to
receive state-prepared lectures or materials about fetal development. Forty-four states
have laws mandating that only a physician may perform an abortion (National Abortion and Reproductive Rights Action League 2001). For an excellent discussion of the
applicability of state laws that were designed to regulate surgical abortion to the use of
mifepristone, see Jones and Heller (2000).
10. In 1995, South Carolina adopted a 27-page listing of abortion clinic regulations
(South Carolina Regulation 61-12) requiring, among other things, that physicians perform extra medical tests on women seeking abortions and that clinics have wider hallways and doorways, higher than normal ceilings, closely regulated temperature and air
flows, and alarms in bathrooms. Lawyers for South Carolina abortion providers argued
that these restrictions were unduly burdensome and that “under the guise of promoting
maternal health, these regulations actually threaten women’s health by significantly
hindering their access to safe, legal abortions.” In August 2000, the Fourth Circuit
Court of Appeal reversed a lower court ruling that South Carolina’s TRAP law imposed an undue burden on women’s right to choose because it treated abortion differently from other medical conditions (Greenville Women’s Clinic v. Bryant 2000). On
February 26, 2001, the Supreme Court refused to hear a challenge to the Fourth Circuit
Court’s decision and allowed the law to take effect (Jackson 2001).
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11. These bills would reimpose restrictions that the FDA considered but rejected in
their final approval. See Schroedel and Corbin (this volume) for a discussion of these
restrictions.
12. Although this paper focuses on legal efforts to curtail or expand access to
mifepristone, it is important to recognize this is only one part of the story. The harassment and social ostracism experienced by those who perform surgical abortions is also
being used against general practice doctors who decide to offer medical abortions to
their patients. See Joffe (2000) for a case study chronicling the experience of one family practice center that provided a mifepristone induced abortion to a single patient.
13. Hawaii is considering a bill requiring mandatory parental consent prior to prescribing mifepristone for minors (Hawaii H.B. 1639). Kentucky is considering two bills:
one that would allow pharmacists to refuse to fill prescriptions for mifepristone and another that would require parental consent for the prescription of mifepristone to minors
(Kentucky S.B. 26; Kentucky B.R. 103P). New Jersey is considering a ban on the use of
state funds to pay for abortions, including mifepristone-induced ones (New Jersey A.B.
1952). Two different bills banning the use of mifepristone have been introduced into the
Oklahoma state legislature (OK H.B. 1038; OK H.B. 1809). An Ohio bill would make
it a felony to “give, sell, dispense, administer, otherwise provide, or prescribe RU 486
(mifepristone) to another for the purpose of inducing an abortion in any person or enabling the other person to induce an abortion in any person” (Ohio Bill HR 360).
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