Mifepristone approval delayed, supporters look to action by FDA

Research and training continue while federal agency weighs facts

While the federal Food and Drug Administration (FDA) continues to analyze information needed for the U.S. marketing approval of the abortion drug mifepristone, supporters are using the time to continue provider training, education, and research of the medical abortion option.

In its Feb. 18 request for information, the FDA again issued an approvable letter on the mifepristone/misoprostol drug regimen, which echoed its original action of Sept. 18, l996.1 An approvable letter is an action frequently used by the FDA to indicate that safety and efficacy data have passed agency review but additional information must be submitted before final approval for marketing is granted. (Contraceptive Technology Update reported on the FDA’s original action in November 1996, p. 141.) New York City-based Danco Laboratories LLC is licensed by the Population Council to make and distribute the drug.

The FDA approval process is moving forward, confirms Sandra Waldman, director of public information for the Population Council, a nonprofit research center based in New York City that holds the U.S. patent rights to mifepristone. "We are continuing to meet with the FDA and will satisfy all their requests for information," she says.

The National Abortion Federation (NAF) in Washington, DC, which represents the nation’s largest group of abortion providers, has held 12 regional provider training sessions this year, with more scheduled around the country, reports Vicki Saporta, NAF executive director. Average attendance has been 75 at each training session.

In addition, NAF offered a medical abortion track at its April annual meeting and will make presentations at the annual meetings of the Washington, DC-based American College of Obstetricians and Gynecologists and the Association of Reproductive Health Professionals, both in Washington, DC, the American Medical Women’s Association in Alexandria, VA, the Planned Parenthood Federation of America in New York City, and the Society of Teachers of Family Medicine in Leawood, KS.

"The trainings have received very positive evaluations in the regions where they have been conducted," notes Saporta. "Providers are very enthusiastic about offering this new technology to patients."

Look for a supplement on mifepristone to be published in this month’s issue of the American Journal of Obstetrics & Gynecology, says Saporta. NAF is putting the finishing touches on its CD-ROM presentation and self-study guide, and it plans to produce videotapes on the ubject.

"All of our training is accredited, and the training materials will be the accredited for continuing medical education," she says. "We have the finest physicians and clinicians in the country working with us on our materials and our trainings."

The years of waiting for mifepristone have not been idle or wasted, asserts Carolyn Westhoff, MD, MSc, medical director of family planning at Columbia Presbyterian Medical Center and associate professor of clinical OB/GYN and public health at Columbia University in New York City.

"There may be a small silver lining in the [approval] delay in the U.S. because we have had the chance to study innovative protocols," Westhoff reflects. "The protocols now in use in U.S. clinical studies are more effective, more flexible, and simpler to implement for patients and providers."

In addition, the time spent waiting on FDA action has allowed the creation of an experienced group of clinician-investigators and counselors, which makes training on this topic much better than it would have been a decade ago, Westhoff says.

The New York-based advocacy group Abortion Rights Mobilization copied the drug in 1994 and has been producing and distributing doses free of charge to more than 5,000 women seeking early abortions at 15 clinics around the country.2 The group also is supplying the drug to University of Rochester (NY) School of Medicine scientists, who are looking at use of the drug in shrinking fibroid tumors.2 (See information on mifepristone research in the December 1997 CTU, p. 149.)

Offer options to women

Providers who are considering offering the mifepristone/misoprostol regimen pending FDA approval should keep several key elements in mind. First, the method is not the important issue, states Mitchell Creinin, MD, director of family planning and family planning research and associate professor in the department of obstetrics, gynecology, and reproductive sciences in the University of Pittsburgh School of Medicine.

Creinin has conducted research on various medical abortion regimens, and he presented on the topic "Mifepristone and Methotrexate in Early Abortion" at the recent Contraceptive Technology conferences.

Any woman seeking an abortion must be certain of her decision and be fully counseled about all of her pregnancy options, including early surgical, early medical, delivery, and adoption, says Creinin. "Medical abortion is just that — an abortion," he explains. "Only once a woman is certain that she wants to not continue the pregnancy should she then decide between medical and surgical options."

Providers must not fall into a salesperson role when it comes to discussing medical and surgical abortion options, he stresses. "Medical is not always better than surgical, or vice versa. It is the clinician’s responsibility to make sure the patient is fully informed, with truthful information, so that she can decide which option is better for her, given her personal and individual circumstances."

Women might choose medical abortion because they fear a surgical procedure, an issue that should be addressed during the counseling session, says Creinin. NAF offers a fact sheet, First Trimester Abortion Options, which covers the advantages and disadvantages of both medical and surgical abortion. (For ordering information, see resource box, below right.) Women must understand the process of medical abortion and the time needed to complete the procedure.

Help women make informed choice

What can women expect from a mifepristone abortion? According to a mifepristone fact sheet prepared by NAF:

• It will take three visits to complete the procedure.

• The average number of days a woman bleeds after taking mifepristone is eight or nine, compared with five for a surgical abortion.

• Some women may see pregnancy tissue.3

"Women who want a medical abortion are really no different, at this point in time, than women who want an early surgical abortion," Creinin notes. "Women who realize very early that they are pregnant and want to have an abortion are grateful to have a caring clinician who will take care of them as soon as possible, not make them wait until they are further in pregnancy [and have morning sickness], and who will be honest about the pros and cons of the options."

Women who choose to have a medical abortion are happiest after the procedure when they have been told upfront the reality of what the experience could be like, concludes Creinin. Common side effects such as cramps similar to those with a heavy period, headache, nausea, vomiting, diarrhea, and heavy bleeding should be discussed.4

"It is always easier for the woman if it is not as bad as she anticipated, compared to being worse than she expected," he notes.

Hotline offers answers

NAF operates a toll-free hotline, (800) 772-9100, to answer women’s questions about mifepristone. It will add more capacity to the hotline pending FDA action, says Saporta. The organization also is developing a Web site to provide further information on the subject.

"We are basically the organization to contact if you are looking for medical abortion materials or training," she notes. "We also are going to be referring women through our toll-free hotline to qualified service providers in their area."

References

1. Food and Drug Administration. FDA Issues Approvable Letter for Mifepristone. FDA Talk Paper. Rockville, MD: Feb. 18, 2000:T00-12.

2. Lewin T. Pending FDA approval, French abortion pill is getting limited use here. New York Times, March 5, 2000.

3. National Abortion Federation. "Mifepristone: Facts at Your Fingertips." Washington, DC, Web: www.prochoice. org/facts/mifepris.htm.

4. National Abortion Federation. "What is Medical Abortion?" Washington, DC, Web: www.prochoice.org/ facts/medad.htm.

To order a copy of the fact sheet First Trimester Abortion Options (single copies are free) or for more information on abortion services in the United States, contact:

National Abortion Federation, 1755 Massa-chusetts Ave. N.W., Suite 600, Washington, DC 20036. Telephone: (202) 667-5881. Fax: (202) 667-5890. Web: www.prochoice.org. NAF also operates a toll-free hotline, Monday-Friday, 9 a.m.-7 p.m. EST: (800) 772-9100.