Mifepristone approval won’t remedy the abortion restrictions you face
Prepare to comply with or challenge abortion laws
The recent approval of Mifeprex (mifepristone, formerly known as RU-486) closes a chapter begun in 1983 when the Food and Drug Administration (FDA) issued a testing permit for the drug to the New York City-based Population Council. However, it does not mean the end of the battle over reproductive rights.
According to the Center for Reproductive Law and Policy (CRLP), a New York City-based legal advocacy organization, the mifepristone/ misoprostol regimen is subject to the same laws many states have enacted that restrict women’s access to surgical abortion.
"It is not a magic pill that will make the burdensome abortion restrictions on the books in every state in the nation vanish," observes Janet Benshoof, the center’s president. "Despite mifepristone’s great potential to improve medical services for women, anti-abortion state legislatures have already erected a labyrinth of laws restricting all abortions." Such laws include prohibitions on public hospital abortions, parental notification laws, state-mandated information designed to discourage abortion, and mandatory delay requirements, according to the CRLP.
Thirteen states — Idaho, Indiana, Kansas, Louisiana, Mississippi, Nebraska, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Utah, and Wisconsin — enforce laws that require physicians to provide abortion patients of any age with state-scripted information and then wait a specified period of time before the patient can consent to the abortion.1
State abortion restrictions already in effect do not distinguish between medical and surgical abortion and may apply equally to those procedures, the center states. For example, parental notification and consent laws, in effect in 31 states, can be applied to any abortion situation, notes the CRLP. Other laws, such as "physician-only" laws, which prohibit nonphysicians from performing abortions in 43 states, might apply to health care providers who assist with medical abortion. In 14 states — Alabama, Arkansas, Connecticut, Florida, Kentucky, Mississippi, Missouri, Nebraska, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin — targeted regulation of abortion provider laws, known as TRAP laws, might force doctors interested in offering patients medical abortion to comply with burdensome regulations faced by surgical abortion providers, such as meeting strict physical plant and staffing requirements.
The waning days of the 106th congressional session saw the introduction of the RU-486 Patient Health and Safety Protection Act in the House and Senate (H.R. 5385 and S. 3157). The legislation sought to limit distribution and use of the drug to licensed physicians qualified to handle complications resulting from an incomplete abortion or ectopic pregnancy, and it asked that providers be trained and authorized by law to provide surgical abortion and have certification for the ultrasound dating of pregnancy. However, the bill did not make it to the floor for debate.
The congressional legislation also touched on the safety of using misoprostol, a prostaglandin. Under the FDA approval, a woman first takes 600 mg of mifepristone (three 200 mg pills) by mouth. Two days later, she takes 400 mcg (two 200 mcg pills) of misoprostol. Women must return for a follow-up visit approximately 14 days after taking mifepristone to determine whether the pregnancy has been terminated.
While the approved regimen calls for the use of misoprostol, the drug does not carry a specific indication for such use. Marketed in the United States as Cytotec by Searle in Skokie, IL, misoprostol was approved in 1988 for treatment of gastric ulcers. Since that time, it has been the focus of "off-label" research, not only for use in medical abortion, but also in inducing early labor in obstetrical patients.
Off-label use disputed
Searle issued a national letter in August 2000 to health care providers, stating that "Cytotec is not approved for the induction of labor or abortion." In the letter, the company said it had received reports of "maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo- oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain" in off-label use of the drug in pregnant women.2 The letter had a chilling effect on obstetrical practice, with many teaching hospitals pulling the drug from pharmacy shelves.3
The recent congressional legislation echoed Searle’s concerns regarding the safety and efficacy of misoprostol when used for purposes other than treatment of gastric ulcers. The Washington, DC-based American College of Obstetricians and Gynecologists (ACOG) quickly issued a letter to congressional sponsors of the bill not only to support the FDA-approved mifepristone/misoprostol regimen, but also to emphasize the safe use of misoprostol in early labor induction of labor.
"The Committee [on Obstetric Practice] recently reviewed the FDA data on adverse events and other available scientific and clinical data in light of Searle’s warning," states the letter, signed by Ralph Hale, MD, FACOG, executive vice president of ACOG.4 "After this careful and extensive review, the Committee stands by its November 1999 recommendation on the use of misoprostol as a safe and effective drug when used to induce labor and ensure the delivery of healthy babies."
Misoprostol is a very safe and effective drug when used in the medical abortion regimen, states Vicki Saporta, executive director of the Washington, DC-based National Abortion Federation (NAF). She notes that most drugs are regularly used "off-label," based on evidence of data that have been collected since initial regulatory approval.
NAF’s telephone lines have been busy since the Sept. 28 FDA announcement on mifepristone. Interest is coming not only from women who want to know more about the method, but also from providers who are considering implementing the mifepristone/misoprostol regimen in their own practices, says Saporta.
"So far this year, we have trained over 1,200 health care professionals — doctors, advanced practice nurses, counselors, administrators, all of the various health care professionals — who would be involved in service delivery," she says. "Over the summer, we surveyed our members, and we know that at least two-thirds will begin offering mifepristone when it becomes available in the United States."
The drug will be distributed by Danco Laboratories, a New York City-based pharmaceutical firm under license by the Population Council to sell Mifeprex in the United States. Delivery of the drug to providers’ offices was pending as this issue of Contraceptive Technology Update went to press.
A number of Planned Parenthood centers are poised to provide mifepristone services as soon as the first shipments are delivered from Danco. Officials at Planned Parenthood Federation of America in New York City expect 165 Planned Parenthood health centers to offer mifepristone within a year.
NAF is mailing members start-up packets filled with copies of protocols, consent forms, and patient education materials to help implement mifepristone/misoprostol services, says Saporta. The organization has conducted more than 16 regional training programs on medical abortion this year and will repeat them in 2001, she notes.
Providers also can obtain continuing medical education credits through NAF’s self-study guide, CD-ROM, and videotape series. The materials are under development and will be available through NAF’s medical abortion Web site, www.earlyoptions.org, says Saporta. The organization also plans a satellite conference in 2001 so providers in university teaching hospitals and other similarly equipped facilities can gain information on medical abortion training.
Ultrasound training sessions are being implemented to aid those providers who want to use the diagnostic method to date early pregnancies and confirm completion of the medical abortion process, reports Saporta.
"Anyone who is interested in adding mifepristone to their practice will have more than enough education material, practical material, and whatever they need to start up and offer these services to women," says Saporta.
References
1. Jones BS, Heller S. Providing medical abortion: Legal issues of relevance to providers. J Am Med Womens Assoc 2000; 55(3 Suppl):145-150.
2. Cullen M. Dear health care provider [letter]. Skokie, IL: U.S. Searle; Aug. 23, 2000.
3. Korry E. Ulcer drug risks. "Morning Edition," Oct. 12, 2000.
4. American College of Obstetricians and Gynecologists. ACOG issues letter on safety of misoprostol. Press release. Washington, DC; Oct. 12, 2000.
Resources
• Mifeprex hotline, (877) 432-7596 [(877) 4 Early Option]. Web: www.earlyoptionpill.com.
• National Abortion Federation, 1755 Massachusetts Ave. N.W., Suite 600, Washington, DC 20036. Phone: (202) 667-5881. Fax: (202) 667-5890. Web: www.prochoice.org. NAF operates a hotline (800) 772-9100, staffed by bilingual operators, Monday-Friday from 9 a.m. to 7 p.m. Eastern time. Web site: www.earlyoptions.org.
• Center for Reproductive Law and Policy, 120 Wall St., New York, NY 10005. Phone: (917) 637-3600. Fax: (917) 637-3666. E-mail: [email protected]. Web: www.crlp.org.
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