FDA Approval of "Abortion Pill" Shifts Debate in the States

The controversial "abortion pill," originally known as RU-486, finally received approval from the federal Food and Drug Administration (FDA). The ruling, announced in September 2000, has sparked an explosion of new anti-abortion legislation across the states.

It is expected that opponents of Mifeprex, the brand name for the pill, will introduce legislation in nearly every state legislature to block or significantly restrict the availability of the drug.

Legislative strategies against Mifeprex may include: prohibiting physician’s assistants or nurse midwives from prescribing the drug; limiting administration of the drug to certain facilities; or imposing waiting periods.

"This is likely to be the biggest battle of reproductive health in a decade," commented Elizabeth Arndorfer, Director, Proactive Reproductive Health Policy Institute at the National Abortion Rights Action League (NARAL). "Legislators need to understand not only how Mifeprex works but how important it is to ensure its availability."

Mifeprex, marketed as RU-486 in other countries since 1981, is widely available in Europe where more than 600,000 women have used the drug to terminate an early pregnancy without having to submit to a surgical procedure.

Using Mifeprex to terminate a pregnancy is called a "medical abortion." Mifeprex, which can only be used during the first seven weeks of pregnancy, blocks a hormone that is necessary for a pregnancy to continue. Used in conjunction with the drug misoprostol, the combination is administered during three visits over two weeks time.

Many doctors who are not willing to perform surgical abortions have said that they would prescribe Mifeprex. This is significant because 86 percent of counties in the U.S. have no identified abortion provider. With more doctors providing this drug in their offices, women will be able to make decisions about reproductive health in private and abortion opponents will have a harder time harassing health clinic patients and staff.

Expected Tactics Against Mifeprex

• Physician-only requirements. In some cases, health care providers who are not MDs, which include physician’s assistants, advanced RNs and nurse midwives, can write prescriptions. Abortion opponents may try to limit Mifeprex providers to only those who can legally perform surgical abortions. Physician-only requirements for surgical abortions currently exist in 44 states.
• Facility requirements. Some states have enacted burdensome laws that only apply to abortion facilities. These facility requirements include directives for expensive clinic renovations, patient-testing mandates or staffing requirements.
• Fetal Remains Disposal. Some states specifically control post-abortion disposal or examination of fetal tissue. Although the induced miscarriage will likely occur outside the medical facility, anti-abortion lawmakers or prosecutors could try to enact or enforce these requirements for the administration of Mifeprex.
• Waiting periods. Abortion waiting periods already exist in at least 19 states. If these requirements are enforced for Mifeprex, women would be required to visit a provider four times, increasing the difficulty of receiving the treatment for women needing time off from work or needing to travel long distances.

Other Potential Attacks on the Use of Mifeprex

When the FDA was considering the approval of Mifeprex, abortion opponents urged the following restrictions which might also form the basis for state legislation:

• A public listing of Mifeprex providers that could be obtained by anti-choice activists through a Freedom of Information Act request;
• A requirement that the physician’s office be within one hour of a hospital and that the physician have admitting privileges;
• A requirement that ultrasound always be performed before giving women Mifeprex;
• A requirement that a third party attest that providers have received training in providing Mifeprex.

Last year alone, 439 bills to restrict abortions were introduced in state legislatures, and 70 were enacted in 34 states. Nine states considered but did not adopt measures specifically restricting access to Mifeprex or controlling the dispensing of information about it in anticipation of FDA approval.

For additional resources and policy briefs concerning Mifeprex and reproductive choice, click here.