Medication abortion, commonly known as the abortion pill or RU-486, is a non-surgical procedure by which pregnancy is terminated through the use of two drugs. The first drug, mifepristone, works by blocking the hormone progesterone, which causes the lining of the uterus to break down so that the pregnancy cannot continue. The second drug, misoprostol, which causes cramps and heavy bleeding that usually lasts for a few hours, induces contractions and ends the pregnancy.
According to Planned Parenthood, women choose medication abortion because they believe that it is a more natural way to terminate a pregnancy, because it can be done at the earliest stages of pregnancy, and because the abortion process can be completed in the privacy of their own home.
Medication abortion has been used around the world for nearly three decades. It was first approved for use in France and China in 1988, then in Great Britain in 1991, in Sweden in 1992, and throughout Europe in the 1990s. The Food and Drug Administration (FDA) finally approved medication abortion for use in the United States in 2000.
Since then, anti-choice advocates have targeted medication abortion in their efforts to wind back access to safe abortion care. In particular, groups such as Americans United for Life have drafted model bills specifically tailored to render medication abortion inaccessible. These model bills force doctors to administer medication abortion in a manner that contravenes research-driven guidelines published by the most trusted professional and scientific organizations like the World Health Organization, the American College of Obstetrics and Gynecology, and the American Medical Association.
When the FDA first approved medication abortion, it adopted the regimen that had been developed by researchers in France in 1988, which required three visits to a physician: first for counseling and to obtain a 600 mg oral dose of mifepristone; a second visit two days later to obtain a 400 mg oral dose of misoprostol; and finally a follow-up visit 14 days after the first visit.
However, current medical consensus—including the findings of studies conducted under the auspices of the World Health Organization (WHO)—says this protocol is outdated.
For example, WHO research demonstrates that the dosage of mifepristone can be reduced to 200 mg, instead of the 600 mg that is still required under the FDA rules. In addition, the original mifepristone/misoprostol regimen specified that medication abortion is effective only up to seven weeks, but researchers found that it was effective up to 63 days’ gestation, or about nine weeks. Finally, the FDA protocol requires multiple trips to a physician despite the fact that researchers found that women could self-administer the misoprostol at home, thus obviating the need for the second visit to the physician to obtain the drug.
In order to account for developments in medication abortion research, the National Abortion Federation (NAF) publishes Clinical Policy Guidelines (CPGs) that reflect the FDA-approved labeling for mifepristone, and also includes evidence-based alternatives to the FDA-approved regimen. The CPGs set the standards for abortion care in North America. They were first published in 1996 and are reviewed and reissued annually. Before mifepristone was approved by the FDA in 2000, NAF and PPFA were jointly conducting education and training programs, which included evidence-based regimens.
NAF does not require its members to use the FDA protocol and only requires members to use evidence-based regimens in keeping with the medical practices in the U.S. and Canada. Indeed, as far back as 2001, 83% of abortion providers in the United States were no longer adhering to the FDA protocol. While it may seem odd for clinicians to adhere to guidelines that contravene FDA-approved guidelines, according to the National Abortion Federation, the FDA explicitly permits the evidence-based use of approved medications in ways that are different from the package labeling (“off-label” use) as long as clinicians receive informed consent from the patient, and are guided by accepted medical practice when determining whether to use drugs in alternative regimens rather than FDA-specified regimens.
Examples of Medication Abortion Restrictions (last updated October 9, 2015)
As reported by the Guttmacher Institute, medication abortion restrictions generally fall into three categories: (1) requiring licensed physicians to perform medication abortions; (2) requiring the abortion provider to be physically present during the procedure and counseling session; (3) and requiring strict adherence to the outdated FDA protocol.
Thirty-nine states prohibit any clinician aside from a licensed physician from performing medication abortions, even though the World Health Organization, the American College of Obstetricians and Gynecologists (ACOG), American Public Health Association and American Medical Women’s Association all support training non-physician providers (such as nurse practitioners and physician assistants) to administer medication abortion.
Fourteen states require that the medication abortion provider be physically present during the procedure. These laws effectively ban “telemedicine,” where physicians use a remote-controlled system to see patients and dispense abortion medication. Bans on telemedicine are particularly detrimental to women who live in rural areas and may find it difficult to make multiple trips to a healthcare provider for medical abortion. Telemedicine bans also harm low-income women due to transportation costs, child care, and lost wages that result from multiple trips to an abortion provider.
Two states (Ohio and Texas) require mifepristone to be provided in accordance with the outdated FDA protocol. A third state, Arizona, is set to implement regulations requiring the use of the FDA protocol beginning in April 2014, although a lawsuit challenging the regulation was filed in early March 2014. Two additional states, North Dakota and Oklahoma have enacted laws requiring the use of the FDA protocol, but the laws have been blocked by courts and are currently not in effect. Anti-choice legislators have advocated these types of laws, which require medication abortion to follow the FDA protocols, claiming that such restrictions are in the interest of the health and safety of women. In reality, however, such restrictions are an attempt to ban outright, legislate the administration of, or interfere in the delivery of medication abortion. These restrictions have also resulted in the arrest and prosecution of women who buy or are suspected of buying abortion pills online.
The American Medical Association and ACOG have spoken out against the efforts in Texas and elsewhere to dictate medical practice by forcing physicians who prescribe medication abortions to follow the FDA protocol. In an amicus brief filed before the Fifth Circuit Court of Appeals in Planned Parenthood v. Abbott, ACOG stated its opposition to the medication abortion restrictions set forth in Texas’s omnibus abortion bill, HB 2. “Legislators should not block advances in medical care by prohibiting physicians from incorporating the best, and most current, scientific evidence into their patient care,” the ACOG brief in opposition to the Texas restrictions notes:
“Requiring physicians to follow a protocol that is scientifically proven to be inferior to other regimens is an unwarranted intrusion in the physician-patient relationship. The practice of medicine should be based on the latest scientific research and medical advances.”
ACOG and the Society of Family Planning reiterated this point in new guidelines on medication abortion issued in February 2014 writing that, “Based on efficacy and adverse effect profile, evidence-based protocols for medical abortion are superior to the FDA-approved regimen.”
Texas Abortion Access
Texas has seen some of the nation’s most regressive abortion restrictions in recent years. This series chronicles the fall-out of those laws, and the litigation that has followed.