Laws and Regulations Affecting Medical Abortion
Notes 1 Oklahoma HB 1038
Medical abortion is a safe and effective non-surgical method of early pregnancy termination. The FDA has approved one drug specifically for use in early abortions.1 Mifepristone (also known as RU 486) is now available under the trade name Mifeprex. This medication has been used successfully by more that half a million women in Europe for over a decade and has recently undergone the rigorous Food and Drug Administration (FDA) approval process.
Abortion is one of the most highly scrutinized, politicized and regulated medical procedures performed today in the United States. The majority of the abortion laws were drafted at a time when medical abortion was not available and pregnancy termination was always achieved by surgical means. Despite the fact that many of these laws do not make sense in the context of medical abortion, they can and will be most likely enforced against providers of medical abortion.
Some states have issued regulations or passed legislation to formally include medical abortion in a legal definition of abortion previously only applied to surgical procedures, while others have tried to further restrict its use. Members of Congress, the Administration, and state lawmakers are also considering further burdensome regulations. All of these restrictions are unnecessary, as anti-abortion state legislatures have already erected a labyrinth of laws restricting all abortions, and the safety of mifepristone is well established. The following examines some of the ways that these existing abortion restrictions apply to medical abortion.
“Physician–Only” Laws
Some non-physician health care providers, such as physician assistants, advanced registered nurses or nurse midwives, currently have the authority to prescribe or dispense a range of drugs under their state laws. However, the majority of states enforce “physician-only” laws that make abortion a crime unless performed by a licensed physician. Thus, non-physicians who provide medical abortion in the 45 jurisdictions with “physician-only” laws risk prosecution and penalties under the law. Some government officials may choose to ignore these laws because they believe they were not intended to apply to medical abortion but prosecutors in anti-choice jurisdictions may well be inclined to take legal action against mid-level providers who prescribe or dispense abortifacients.
Targeted Regulation of Abortion Providers (“TRAP”) Laws
Many states have enacted burdensome laws that single out facilities at which abortions are performed and subject them to regulations that do not apply to other physician offices or outpatient clinics. Targeted regulation of abortion providers, or “TRAP” laws, vary with regard to the burdens imposed, facilities to which they apply, and the type of abortion performed. Some TRAP laws require compliance with relatively minimal licensing provisions while others contain detailed and sometimes confusing and expensive structural, staffing, patient testing and other requirements. TRAP laws pose a deterrent to the use of medical abortion, as onerous requirements may limit the number of providers and/or clinics willing to offer medical abortion. In general, TRAP laws do apply to medical as well as surgical abortions.
Forced Parental Involvement and Mandatory Delay Laws
As a general matter, state laws that require parental consent or notice before an abortion may be performed (forced parental involvement laws) and state laws that require a waiting period after a woman receives certain state-scripted information (mandatory delay and biased counseling laws) apply to medical abortion just as they do to surgical abortion.
More than half the states enforce some form of forced parental notice or consent law. Some states require that notice to the parents be followed by a waiting period (up to 48 hours). Some states also currently enforce waiting period laws on women of all ages seeking abortions and these laws apply to medical, as well as surgical, abortion. Most often, these waiting periods must occur before the first dose of mifepristone is administered.
Food and Drug Administration Regulations
In approving mifepristone for use as an abortifacient, the FDA enumerated various restrictions on distribution of the drug. The drug must be provided by or under the supervision of a physician who is able to assess the duration of pregnancy accurately and to diagnose ectopic pregnancies. Practitioners prescribing mifepristone must either have the ability to provide surgical intervention in uncommon cases of incomplete abortion or severe bleeding, or have made plans to provide such care through other qualified physicians. While complications are rare, providers must also be able to assure patient access to fully equipped medical facilities.
In addition, FDA guidelines include a protocol ensuring that all patients receive a full explanation of the procedure and are provided with an opportunity to discuss any questions regarding medical abortion. Providers must then obtain the woman’s signature on a patient agreement, which they must sign as well. Physicians prescribing mifepristone must also agree to report any serious complications, including information about any patients for whom mifepristone is not effective, resulting in the need for a surgical abortion. It should be noted, however, that a woman’s signature on a patient agreement does not replace the state law concerning informed consent procedures.2
Other Laws Affecting Medical Abortion
Numerous states have laws that require specific kinds of disposal or examination of fetal tissue after an abortion. These laws are generally impractical or even irrational when applied to medical abortion because the woman usually expels the fetal tissue at home. The health care provider who prescribed the drugs for the medical abortion could, however, face penalties or prosecution unless the tissue is saved and examined.
Most states require abortion providers to report certain information to the state or keep records of certain information for possible state inspection. Many states require a provider to report each abortion that is performed. These reporting requirements apply to medical abortion as well.
New Efforts to Restrict Medical Abortion
New legislation aimed at directly restricting medical abortion has been proposed 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 2003 in 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 August 2002 a coalition of anti-choice groups submitted a 92-page petition to the FDA calling for the Commissioner of the FDA to halt all distribution and marketing of the drug. Additionally, President Bush has appointed Dr. David Hager as a member of the Reproductive Health Drugs Advisory Committee of the Food and Drug Administration (FDA), the committee that is responsible for analyzing the safety and effectiveness of drugs used in reproductive health care. Dr. Hager, prior to this appointment, reportedly helped draft the petition requesting the FDA to rescind its approval of mifespristone, which is used to provide safe, early medical abortions. Further restrictions could be eminent as the petition is considered by the panel on which Dr. Hager now sits.
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 between the Center for Reproductive Rights and the state resolved most of the challenge to Michigan’s mandatory delay for abortion law, which had been modified to prohibit state-mandated abortion literature from describing any procedure that uses a drug that hasn’t been specifically FDA-approved for use in an abortion. Misoprostol, FDA-approved as an ulcer medication and used “off-label,” is necessary to successfully complete an abortion using mifepristone.
After a 1995 Mifepristone clinical trial involving 2,100 women in the U.S.:
*Statistics from 1998 Kaiser Report “Will 1999 Be the Year for Mifepristone (RU-486)?”
2 HR 486, sponsored by Vitter. S 251, sponsored by Hutchinson.
