The Food and Drug Administration has said that it will decide by September 30 whether to approve the abortion pill RU-486 for prescription use in the U.S. Introduced in France in 1988, the drug has now been used to induce about 500,000 abortions in more than a dozen countries, and it has earned a good safety record in the process. The FDA has been postponing a decision on the drug for years, citing safety concerns. The real reason, though, has been pressure from anti-abortion advocates.
RU-486, also called mifepristone, works by blocking the action of progesterone, the ovarian hormone that maintains the lining of the uterus in a state suitable for pregnancy. It is used early in pregnancy within seven weeks of the last menstrual period. The drug causes the fetus to detach from the uterine lining. Sometimes this is followed by expulsion of the fetus and its membranes; if not, another drug called misoprostol (a member of the prostaglandin family) is given two days later. This drug stimulates uterine contractions and completes the abortion.
Like other abortion procedures, the use of RU-486 can lead to complications, the most common being prolonged bleeding. In most cases, though, this resolves without the need for medical or surgical intervention.
RU-486 is not the same thing as the “morning-after pill,” which contains either diethylstilbestrol or high-dose oral contraceptives. The morning-after pill prevents conception or implantation, whereas RU-486 is a true abortion drug it causes the detachment of an already implanted fetus. It is for this reason that it has triggered so much more opposition in the U.S. than the earlier drugs.
President George Bush banned importation of the drug from France, and it was only after President Clinton took office that testing of RU-486 began in the U.S. In 1996, the FDA gave the drug preliminary approval, noting its apparent safety and effectiveness. So why is it still not available four years later?
The story has a lot more to do with politics than with science. At a time when fewer and fewer doctors are willing to practice abortion on account of threats to their safety, anti-abortion activists worry that RU-486 will reverse this trend. Abortion, they fear, will move out of easily targeted abortion clinics and become just another facet of day-to-day medicine, hidden from prying eyes by the usual rules of patient confidentiality. Thus, the Republican-controlled House of Representatives has twice voted to prevent testing and approval of the drug, and Republican presidential nominee George W. Bush will likely attempt to block the drug’s use, if he is elected.
The four-year delay since preliminary approval of the drug has not been entirely the fault of the FDA: the drug’s original U.S. manufacturer backed out in 1997, and much of the bureaucratic process had to be repeated after a new manufacturer was found. But in June of this year, the FDA proposed a set of regulations for the use of RU-486 regulations that, if enacted, will prevent the drug from seeing widespread use. Two of the regulations arouse particular concern: one says that the drug can only be issued by medical practitioners who are trained in surgical abortion, and the other says that these practitioners must be specially certified and their names kept in a registry.
The purported reason for these regulations is medical in nature. On rare occasions, RU-486 fails to lead to a completed abortion, even with the subsequent use of misoprostol. In such cases a surgical abortion is necessary. However, there is no reason why the original provider of RU-486 could not refer the woman to a doctor trained in surgical abortion, rather than perform the abortion himself or herself. The proposed regulation seems like an effort to restrict the availability of RU-486 to pre-existing abortion practices.
The proposed registry of practitioners certified to issue RU-486 is even more unusual. Its ostensible purpose is to make sure that RU-486 is used in a medically appropriate way, but it runs counter to long-standing policies that give doctors wide latitude in prescribing FDA-approved drugs. The effect of such a rule would be to intimidate doctors who might otherwise prescribe the drug. That’s because a national registry of doctors’ names, even if nominally confidential, will soon fall into the hands of anti-abortion activists, and this in turn will expose the doctors to the same risks of harassment and deadly attacks that abortion providers now have to endure.
Over the last ten years, access to abortion has become increasingly difficult for women in many parts of the U.S. RU-486 offers a real hope of easing the situation, but not if the FDA’s proposed regulations go into effect. It’s hard to resist the conclusion that anti-abortion forces have succeeded in tainting the FDA’s approval process. In my view, the FDA should recognize that abortion is legal, resist political pressures and permit RU-486 to be prescribed like any other drug.