Countdown to Mifepristone final approval. With a September 30 decision deadline looming, women’s advocates, health experts and the pro-choice movement have urged swift final Food and Drug Administration approval of the controversial abortion pill without tough restrictions sought by anti-choice forces.
Widespread distribution of the early-option pill mifepristone, also known by its French name RU-486, could dramatically alter the abortion landscape of intimidation and violence directed at abortion clinics, providers and patients.If the drug is approved after an extraordinary four-year-long process, many women seeking an abortion presumably would visit private doctors or other general-purpose medical clinics for a prescription.
Though the battlefields might shift away from some clinics and though the pill would be a welcome addition to family planning services, many observers say the abortion wars are far from over.
Advocates argue that if approved and widely prescribed, mifepristone also could reduce late-term abortion, including one controversial procedure, because women would be encouraged to make early choices about their pregnancy.
“The longer abortion waits, the more morbidity is associated with it,” said Dr. Laura MacIsaac, an obstetrician-gynecologist and director of family planning at the Albert Einstein College of Medicine in New York.
“The safety risks of mifepristone are not significant compared with routine risks of pregnancy, miscarriage or surgical abortions that physicans encounter every day,” she said September 19 at a hearing on the abortion pill in New York City. The expert testimony amassed, all in favor of broad distribution, will be sent to the FDA.
The National Abortion Federation, meanwhile, released survey results indicating that two-thirds of its more than 360 member facilities nationwide would provide mifepristone, if it were approved.
“With final approval of the early option pill potentially only days away, women will be able to access it if they decide it is the right option for them,” said Vicki Saporta, executive director of the federation. Her organization and others have been training clinicians in the use of the pill.
At issue now are the FDA’s proposed restrictions that would limit distributor-prescribers to medical doctors and health professionals trained in surgical abortion, medically induced abortion and the use and analysis of sonograms. These qualifications would effectively mean that only highly trained medical doctors could prescribe the drug. Doctors also would be required to practice with one-hour from a hospital emergency room where they have admitting privileges.
The proposed regulations would also set up a group, not defined, to certify and keep lists of doctors and others authorized to prescribe the drug. Women’s advocates and doctors fear this last provision could mean dangerous leaks of confidential information to anti-abortion groups and violent protesters.
Doctors, women’s advocates call for unfettered access
Medical and pro-choice groups say all of the restrictions are not only unnecessary but also would make it extremely difficult for women to exercise their legal right to abortion in a country where 86 percent of all counties are without an abortion provider.
Dr. Steve Tamarin, a board member of Physicians for Reproductive Choice and Health, said certification for surgical procedures was not necessary because “physicians can do vasectomies in their offices without certification.” He said that anonymity was essential because of the risk of violence.
At the New York public hearing, the city’s Public Advocate Mark Green and experts on safety, availability and access overwhelmingly endorsed mifepristone. Questions were not taken from the small audience, and anti-choice representatives and protesters were not in evidence.
Saying new Supreme Court appointments could limit or overturn the right to abortion, Green emphasized the importance of swift approval of the drug at this time. It would then be difficult for an anti-choice president to reverse the FDA, unless abortion became illegal, he argued.
“The FDA’s decision on how and whether to offer RU-486 could have as big an impact on women’s reproductive rights as the 1973 Roe v. Wade decision [legalizing abortion] did,” Green said. “I’m surprised that there has been so little public input and conversation on this issue.”
Anti-abortion groups tried unsuccessfully to prevent FDA approval of the drug’s safety and effectiveness. Failing in that, they now are pressing for rigorous restrictions on distribution.
Anti-abortion group takes credit for slowing approval process
“We’ve been successful in slowing down that train,” said Heather Cirmo, spokesperson for the anti-abortion Family Research Council. She referred to the Clinton administration’s frustrated effort to get fast-track approval for the drug. The next best thing to no mifepristone would be to encumber the drug’s distribution with difficult-to-meet regulations, she said.
By September 30, the FDA is expected to exercise one of several options: to approve the drug with or without sweeping restrictions to hobble access. It could also modify the regulations or request a delay and more information from the manufacturer, Danco Laboratories. In order to avoid a broad anti-choice boycott of products, Danco was established with the sole purpose of manufacturing and distributing mifepristone–nothing else.
The drug’s U.S. sponsor and patent holder, the Population Council, hopes their FDA application will be approved without tough restrictions.
“Everyone is discussing regulations based on what was discussed in June,” said Sandra Waldman, council spokesperson. “We’ve been in continuous positive discussions and negotiations with the FDA since then. People should not assume that this or that” will be included in the final decision.
The FDA approves most drugs within one year of determining them to be safe and effective. Mifepristone has been awaiting this final approval for four years and the FDA’s proposed restrictions have been circulated for the past four months. Viagra, the male impotency drug by Pfizer, swiftly received final approval, despite side effects and heart problems, especially for men with cardiac conditions.
Advocates for the abortion drug say that medically induced abortion with mifepristone or another combination of drugs is noninvasive and enables women to make their decisions in private and to take their pills in privacy. It could be available to women in many areas of the country without a surgical abortion clinic. Family doctors, as well as obstetricians and gynecologists not trained in simple surgical abortion procedures, would be able to prescribe medical abortions with the stoke of a pen.
“The hearing demonstrated how such restrictions have no scientific or medical merit,” said Joan Malin, the chief executive officer of Planned Parenthood of New York City. She said doctors are eager to prescribe mifepristone.
“It expands the number of recipients and the number of places where abortion services are provided,” she said.
Experts testified it was not necessary to be trained in surgery to prescribe and effectively monitor medical abortions. They called the proposed surgery training requirement one more onerous restriction on women’s right to choose. Further, they said, since mifepristone is safe and effective, the need to be close to an emergency room–and to have admitting privileges there–undermines the objectives of availability. In order to discourage abortions nationwide, many states have enacted similar requirements for abortion providers to be medical doctors.
Doctors are eager to prescribe mifepristone to their patients, said Joan Malin, chief executive officer of Planned Parenthood of New York City. “These restrictions have no scientific or medical merit.”
A recent survey by the Kaiser Family Foundation reported that 31 percent of gynecologists who have never or not within the last five years performed surgical abortion and 31 percent of family practice physicians, 98 percent of whom do not perform surgical abortions, would be “somewhat likely” to prescribe mifepristone.
The drug’s safety is not in serious question. Approximately 500,000 women in Europe and millions of women in Asia have used the drug for medical abortion, and studies in Europe and the United States have shown that the drug is 95-percent effective for terminating pregnancies within a 49-day gestation period.
All of the physicians who testified in New York said the most important skills in administering the drug are patient counseling and general medical proficiency–not surgical ability.
Elizabeth Randolph is a journalist based in New York.