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Laws and Regulations Affecting Medical Abortion
Medical Abortion: An Alternative for Women
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Medical Abortion: An Alternative for Women

May 2001, Item: F040

Medical abortion is a safe and effective non-surgical method of terminating early pregnancy using certain medications taken orally or through injections. There are currently two methods of medical abortion: mifepristone, formerly known as RU-486, and methotrexate. Both drugs must be used in combination with misoprostol in order to stimulate uterine contractions, which aids in expelling the fertilized egg.

Mifepristone: Approved for Use in the United States

On September 28, 2000, the U.S. Food and Drug Administration (FDA) approved the use of the drug mifepristone as an abortifacient after more than ten years of political pressure by abortion opponents to block its use in the U.S. Mifepristone has been accepted for terminating early pregnancy through medical rather than surgical means since 1988, when the French government approved the marketing of the drug under the trade name RU-486. Available in England and Sweden since the early 1990s, mifepristone has been used by more than one half million women in Europe during the past decade, as well as by women in China.

Medical Abortion with Mifepristone

  • At the first visit, the woman takes mifepristone pills.
  • 48 hours later, she returns to the provider to take misoprostol pills. Most women will abort in the four-hour period following the misoprostol dose.
  • A follow-up visit 12 days later confirms the pregnancy has ended. In a small number of cases, a surgical procedure may be necessary.

Medical Abortion Using Mifepristone & Methotrexate

Mifepristone is a synthetic chemical that blocks progesterone, a hormone necessary to continue pregnancy. This action causes the uterus to shed its lining, as it does in menstruation. An early embryo attached to the lining is shed at the same time. This method is effective up to 63 days of pregnancy (9 weeks), as measured from the first day of the woman's last menstrual period (LMP), though the FDA has approved it only up to 49 days of pregnancy (7 weeks).

Methotrexate is currently available for "off-label" use as a method of medical abortion. "Off-label" refers to the legal use of a drug approved for another purpose. Approved as a cancer treatment by the FDA in 1953, methotrexate's efficacy as an abortifacient was discovered later. Methotrexate terminates pregnancy by blocking cells from multiplying and dividing. This method is effective up to 49 days (7 weeks) LMP.

Both methods also require the use of misoprostol, which stimulates uterine contractions to expel the fertilized egg.

Women Recommend Medical Abortion

Women in the mifepristone clinical trials described the abortion process as similar to menstruation or a natural miscarriage. Many found the act of swallowing a pill more natural than a surgical procedure as well as more private and noninvasive. Findings from the clinical trials indicate that 96%, or nearly all the participants, would recommend the method to others, and 91% would choose it again. Three quarters of the women who had a previous surgical abortion (about half the participants) regarded medical abortion as the better option.

Existing Abortion Restrictions Apply to Medical Abortion

Abortion is one of the most highly scrutinized, politicized and regulated medical procedures performed in the United States. Most state abortion laws were drafted at a time when medical abortion was not available and pregnancy termination was always achieved by surgical means. Although many of these laws do not make sense in the context of medical abortion, they will be enforced against providers of medical abortion.

As early medical abortion regimens become more widely used and available, providers of women's heath care need to question whether, and in what way, existing abortion restrictions apply to medical abortion. Laws that apply to medical abortion include parental involvement laws for minors seeking an abortion, mandatory waiting periods, "physician-only" laws and TRAP (Targeted Regulation of Abortion Providers) laws.

New Efforts to Restrict Medical Abortion

New legislation aimed at directly restricting medical abortion is pending in at least 12 states. The new legislation includes bills that clarify the definition of abortion to include mifepristone, exclude medical abortion from public funding for low-income women, and go as far as making a felony to prescribe or to dispense mifepristone.

Anti-choice politicians in Congress introduced the "Patient Health and Safety Act" in February 2001 in both the Senate and the House of Representatives. If enacted, the measure would, among other restrictions, severely limit the pool of providers of mifepristone to doctors who currently provide surgical abortions, who are "certified" in ultrasound for dating pregnancy, and who have admitting privileges at an emergency room located within one hour of their office. In attempting to impose further restrictions on mifepristone, anti-choice legislators are challenging the integrity of medical practice as well as the FDA's decision-making process.

In addition, Bush-appointee Tommy Thompson, Secretary of the Department of Health and Human Services, has singled out mifepristone as the only drug already approved by the FDA that he intends to re-open for further investigation.

The Center for Reproductive Rights Files First Lawsuit in the Nation Against Ban on Medical Abortions

As a result of the Center for Reproductive Rights' lawsuit, Michigan reversed its ban on medical abortion in March, 2001. A settlement reached between the Center for Reproductive Rights and the state resolves most of the challenges to Michiganís mandatory delay for abortion law, which had been modified to prohibit state-mandated abortion literature from describing any procedure that uses a drug that hasnít been specifically FDA-approved for use in an abortion. Misoprostol, FDA-approved as ulcer medication and used "off-label," is necessary to successfully complete an abortion using mifepristone.

"Michiganís desire to settle this lawsuit should signal to other states that seeking to stamp out early medical abortion through back door semantics wonít work," said Center for Reproductive Rights attorney Julie Rikelman.

Mifepristone: A Long Road to Approval in the United States

1988 - The French government approves the marketing of mifepristone under the trade name RU-486. The United States bans importation of unapproved abortifacients, including RU-486.

1992 - The Center for Reproductive Rights files a legal challenge against the U.S. government's import ban on RU-486 in the case Benten v. Kessler. 791 F. Supp. 281 (E.D.N.Y. July 14, 1992)

1993 - President Clinton orders a review of the import ban.

1994 - In a move to make RU-486 available in the United States, the French manufacturer donates its patent for mifepristone in 1994 to the Population Council, a U.S.-based international nonprofit research organization. The Population Council conducts clinical trials of the drug at locations across the country.

1996 - After reviewing data from the clinical trials, the FDA concludes that mifepristone is safe and effective.

1998 - The nomination of Dr. Jane Henney to head the FDA is held up based on abortion opponents' fears that she would approve RU-486 for use. Only after she commits not to actively solicit a manufacturer for the abortifacient is her nomination confirmed by the U.S. Senate.

1999 - A Congressional abortion opponent amends the fiscal year 1999 agriculture appropriations bill to forbid the FDA from testing or approving RU-486. The amendment is eventually dropped from the bill.

2000 - The Danco Group, the pharmaceutical company holding the license to manufacture mifepristone, makes the drug available for use in November 2000 following the FDA's final approval.

1 Oklahoma HB 1038
2 HR 482, sponsored by Vitter. S 251, sponsored by Hutchinson.

See also:

  • Laws and Regulations Affecting Medical Abortion - factsheet

  • Providing Medical Abortion: Legal Issues of Relevance to Providers, an article published in the June 2000 issue of JAMWA.

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