Memorandum on S 251/HR 482, Which Places Severe and Unwarranted Restrictions on Mifepristone (RU-486)

MEMORANDUM TO:Interested Persons FROM:ACLU Washington National Office RE: S. 251/H.R. 482 -- Legislation to Restrict Mifepristone (RU-486) DATE: May 7, 2001

The ACLU opposes S. 251/H.R. 482, which would impose severe and unwarranted restrictions on mifepristone (commonly known as RU-486), a safe and effective early-option abortion pill. Last fall, the Food and Drug Administration (FDA) approved this drug after more than a decade of careful study. Mifepristone represents a significant breakthrough in reproductive health care for American women. It promises to give women, especially those who live far from an abortion provider, better access to a safe, private, and early option for ending a pregnancy.

Mifepristone's great promise is threatened, however, by anti-choice forces, who are determined to restrict access to this drug. Having failed to block the FDA from approving the drug in the first place, the sponsors of this bill -- Senator Tim Hutchison (R-AR) and Representative David Vitter (R-LA) -- are now attempting to limit its availability under the guise of protecting women's health. Congress should not substitute its views for the considered judgments of medical experts at the FDA.

Mifepristone is Safe and Effective.

Thousands of women in nineteen countries have used mifepristone safely to end unwanted pregnancies. Since 1989, more than a half a million women in Europe alone have used mifepristone as an early and safe abortion option.1

U.S. clinical trials found that mifepristone, followed two days later by misoprostol (a drug used to stimulate uterine contractions), was a safe and effective abortifacient. Between 1994 and 1995, 2,121 women participated in these clinical trials. Less than one percent of all participating patients were hospitalized after taking the drugs: only half of these hospitalizations were related to the drugs; the remainder resulted from unrelated events such as automobile accidents and infectious diseases.2 No deaths were reported. 3

The trials also demonstrated that mifepristone was effective in terminating 92% of pregnancies up to 49 days' gestation.4 A study of the same clinical trials reported that 95.7% of women in the trial would recommend mifepristone to others.5 Even among the small number of women for whom the method failed, 84.9% would nevertheless recommend the drug to others. 6

Mifepristone Will Not Increase the Number of Abortions.

Anti-choice lawmakers contend that the availability of mifepristone will cause more women to have abortions. This claim is simply not supported by the evidence. In countries where mifepristone has been available for many years, the overall abortion rate has not increased. Instead, more women have had earlier and therefore safer abortions.

There is no evidence that making medical abortions available to women as an alternative to surgical abortion affects the overall abortion rate. Since mifepristone became available in France in 1989, the total number of abortions has in fact remained constant.7 In the early 1990s, physicians in the U.S. began to use another safe and effective regime for early medical abortions: methotrexate in combination with misoprostol. The Centers for Disease Control report that in 1997 (the most recent data available), the number of abortions in the U.S. declined to its lowest level since 1978.8 Moreover, of those women having abortions between 1992 and 1997, more had them in the early weeks of pregnancy.9

Congress Should Not Substitute Its Views for the Judgments of Medical Experts at the FDA.

The FDA is the expert body charged with ensuring the integrity of the drug approval process and the safety and efficacy of drugs used in this country. It has made clear that its approval of mifepristone resulted from its careful evaluation of the medical evidence under strict scientific protocols. The FDA approved the drug after three complete phases of clinical trials that took place in the U.S. and in France and involved thousands of women.

While the FDA imposed some restrictions on the drug in its final approval, it chose not to adopt the severe limitations contained in this bill. Indeed, the FDA considered and rejected all of the restrictions that S. 251/H.R. 482 now seeks to impose.10 It is inappropriate for Congress to second-guess the considered judgments of medical experts. This bill substitutes anti-choice politics for science.

The Restrictions in this Bill Are Not Medically Necessary and Would Severely Restrict Access to this Drug, Undermining Women's Health.

S. 251/H.R. 482 would impose severe and unwarranted restrictions on mifepristone. Consider, by way of analogy, a federal bill aimed at limiting prescription power for penicillin to those few physicians who are trained and experienced in treating rare but severe allergic reactions to the drug. Whatever benefit might be gained by receiving the drug from a specialist would be outweighed by lost access to the drug, especially in medically underserved communities. The same is true for mifepristone.

Although the sponsors of this bill claim that the restrictions the bill would impose are necessary to protect women's health and safety, the medical evidence belies their claims. Rather, a close look at the restrictions reveals that they are medically unnecessary and that they will so restrict access to mifepristone as to place it out of reach for American women. In fact, by restricting access to a safe, early abortion option, the bill would actually undermine women's health.