Approval of Ru-486 as a Postcoital Contraceptive

• Publication year: 1993

UNIVERSITY OF PUGET SOUND LAW REVIEWVolume 17, No. 1FALL 1993

Approval of RU-486 as a Postcoital Contraceptive

Kari Hanson(fn*)

"Many people ignore the fact that the incidence of abortion reflects the state of contraception."(fn1) "The real problem with emergency postcoital contraception is not its failure rate or its side effects but the fact that so few women and adolescents who have had unprotected intercourse actually use it."(fn2)

I. Introduction

Each year in the United States, 3.5 million women unintentionally become pregnant.(fn3) Moreover, approximately 1.5 million abortions are performed annually,(fn4) making the United States' abortion rate one of the highest among Western countries.(fn5) Meanwhile, the number of women and children living below the poverty level continues to increase.(fn6) These facts indicate that women urgently need additional methods of fertility control. For many women who unintentionally become pregnant, the consequences are not disastrous. For these women, the decision whether to have an abortion, give the child up for adoption, or keep the child may be clear and have no long-term adverse effects. However, many women face an agonizing dilemma when none of these three options appears viable.

Postcoital contraceptives, which act after fertilization but before a fertilized egg implants in the womb,(fn7) offer women greater control over their own fertility. For example, many unintended pregnancies result from contraceptive failure, such as a condom breaking.(fn8) In these cases, a woman may realize she is at risk of becoming pregnant and use a postcoital contraceptive to prevent an unwanted pregnancy. One such contraceptive, popularly known as the "morning-after pill" because it must be administered within seventy-two hours of unprotected intercourse, has been available for some time but has not been widely used.(fn9)

A significant development in postcoital contraception occurred in 1992 when scientists reported in The New England Journal of Medicine that RU-486, the so-called "abortion pill," was highly effective as a postcoital contraceptive.(fn10) RU-486, a synthetic drug most widely used as an abortifacient,(fn11) was developed in France more than a decade ago.(fn12) Because the drug is highly effective in terminating early pregnancies,(fn13) it has been extremely controversial in this country.(fn14) The heated political debate over abortion, strident opposition from right-to-life groups, and the antiabortion stance of the Reagan and Bush administrations(fn15) have prevented RU-486 from being submitted to the United States Food and Drug Administration (FDA) for approval.(fn16) However, new abortion policies instituted by the Clinton administration appear to be paving the way for submission and ultimate approval of the drug.(fn17) This Comment argues that if RU-486 were approved as a postcoital contraceptive rather than as an abortifacient, the drug would be of greater overall benefit to women seeking to control their fertility.

FDA approval of RU-486 as a postcoital contraceptive would be of greater overall benefit to women than approval of the drug as an abortifacient in a number of ways. First, women would have a broader range of birth control options. Dr. Etienne-Emile Baulieu, the developer of RU-486, has pointed out that women may need several different forms of birth control during their fertile lives, because factors relevant to contraception, including changes in age and in the status of their personal lives, vary over a woman's lifetime.(fn18) Under certain circumstances, a woman may find invaluable a method of birth control that allows decision making to occur after intercourse.

The second major benefit to women of FDA approval of RU-486 as a postcoital contraceptive is that fewer women will require abortions or even face the decision whether to abort. Abortion may raise significant medical and moral issues that are implicated only slightly, if at all, by methods of fertility control that act before a pregnancy has been established. In the United States, the vast majority of abortions are performed legally during the first trimester,(fn19) and no significant complications result.(fn20) However, abortions performed illegally or in the later stages of pregnancy may be associated with serious health risks and even death.(fn21) In addition, many women would not choose abortion under any circumstances because they regard it as taking life. Even among women who believe that abortion must remain legal and available, support for abortion may decrease as pregnancy advances and the fetus begins to look more and more like a person. Reducing the occurrence of unwanted pregnancies will therefore free women from facing what for many is an anguishing moral and ethical dilemma.

Although the need for abortion is unlikely to be completely eradicated, there is little doubt that wider availability and use of postcoital contraceptive methods could help to reduce significantly the number of abortions performed each year in the United States. A 1989 survey of two hundred Planned Parenthood patients who had abortions showed that thirty percent had realized right away that they might be pregnant and would have preferred the morning-after pill to an abortion if they had been aware of the treatment.(fn22) In the Netherlands, where postcoital contraceptives have been available for years, the treatment is cited as the leading reason for an abortion rate one fifth of that of the United States.(fn23)

In addition to benefitting women, FDA approval of RU-486 as a postcoital contraceptive will also benefit the drug's manufacturers and marketers. Such a strategy will allow both the drug's French manufacturer, Roussel-Uclaf, and companies in the United States to avoid much of the abortion controversy that has surrounded RU-486. Many people who are vehemently opposed to abortion will continue to oppose RU-486 as a postcoital contraceptive, both because of its potential use in terminating established pregnancies and because of a belief that even an unimplanted fertilized egg deserves the same protection as a fetus or a person.(fn24) However, fewer people oppose birth control than oppose abortion, and the legal right to privacy in choosing to use birth control has been firmly established in this country since the Supreme Court's decision in Griswold v. Connecticut.(fn25) In upholding this right, courts have not distinguished between birth control methods that act before or after fertilization.(fn26) Thus, those involved in manufacturing, distributing, and marketing RU-486 should focus on its use as a birth control method and work to educate the public about this new use of the drug. This strategy will reduce vulnerability to boycotts or other politically motivated obstacles that could impair wide distribution of a much-needed new drug. With this fear assuaged, manufacturers and marketers will be in a position to maximize profits from licensing the drug in the United States.

Finally, the medical community will benefit if RU-486 is approved as a postcoital contraceptive. Doctors will have another option available to offer women seeking to control their fertility. Moreover, doctors who oppose abortion would probably be more comfortable prescribing RU-486 as a postcoital contraceptive because the medical profession generally views pregnancy as beginning with successful implantation, not with fertilization.(fn27) Reducing the need for abortion will allow medical resources to be directed toward other pressing health problems, such as AIDS and other sexually transmitted diseases. Furthermore, minimizing the abortion controversy at the regulatory level will mean that the drug is available to doctors sooner than it otherwise would be. Because a drug approved by the FDA for one use may be prescribed for other uses,(fn28) doctors will gain access to RU-486 for testing in a wide range of applications including, and in addition to, fertility control.

To support the argument that RU-486 should be approved as a postcoital contraceptive, Part II of this Comment examines the background and development of the drug, the controversy it has engendered, and the drug's recently discovered contraceptive potential. Part III provides a short look at the process by which the FDA approves new drugs and discusses how RU-486 would likely progress through this process. Part IV begins by examining the current postcoital contraceptive regimen, the morning-after pill, and discusses the obstacles associated with the use and the availability of this method. Part rV then discusses the legal, medical, and policy reasons for approving RU-486 as a postcoital contraceptive.

II. RU-486: "The Moral Property of Women"

A. Background

RU-486 was approved for use by the French government in 1988.(fn29) Although the drug has now been used by more than 100,000 French women,(fn30) its introduction was not without considerable controversy. Almost immediately after the drug was licensed, Roussel-Uclaf withdrew it in the face of threatened boycotts and opposition from the Catholic church.(fn31) However, the French government intervened two days later, stating that governmental approval had made RU-486 "the moral property of women" and that if Roussel-Uclaf did not market the drug, the rights would be given to another company.(fn32)

In the United States, introduction of RU-486 was...