RU-486: FDA Approves Controversial Abortion Drug
In an announcement "hailed by abortion-rights supporters as a breakthrough for American women and condemned by abortion opponents as a travesty for endangering human life," the FDA yesterday approved the so-called "abortion pill" mifepristone, also known as RU-486, the Washington Post reports (Kaufman, Washington Post, 9/29). FDA Commissioner Dr. Jane Henney said, "The approval of mifepristone is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug. The FDA's review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency" (HHS release, 9/28). Danco Laboratories, a start-up company based in New York, is set to market mifepristone under the brand name Mifeprex. According to the Washington Post, abortion-rights groups expect the cost of the pill to be similar to a surgical abortion -- roughly $300. Danco has said the pill will be available in about one month (Washington Post, 9/29). "Some or all" health insurers are expected to cover the cost of the pills, "dependent on whether employers are willing to pay extra" for the coverage (LaMendola, Ft. Lauderdale Sun-Sentinel, 9/28). In California, Blue Shield has already decided to cover mifepristone while drug coverage committees at Kaiser Permanente and Health Net are likely to consider the drug within the next three to six months. (Peyton, Sacramento Bee, 9/29)
Only doctors able to perform surgical abortions will be able to distribute mifepristone; the pill will not be available through pharmacies (Rubin, USA Today, 9/29). Mifepristone will be offered in conjunction with a second drug, misoprostol -- currently already on the market as an antiulcer medication -- which will be marketed as Cytotec. Together, the two pills "essentially ... cause a miscarriage": mifepristone blocks progesterone, a hormone which prepares the lining of the uterus for the implantation of a fertilized egg, while misoprostol causes the uterus to contract and expel the uterine lining and embryo (Zitner, Los Angeles Times, 9/29). The FDA, which based its approval on clinical trials in the United States and France, outlined the guidelines for the drug in an HHS press release, saying mifepristone can only be taken within the first 49 days of pregnancy. Furthermore, every woman who receives the drug will be given a "Medication Guide" (MedGuide) that explains the proper method for taking the drug, warns who should avoid the drug and details the possible side effects (HHS release, 9/28). Women who choose to terminate a pregnancy with mifepristone will need to make three visits to a doctor's office or clinic (Rubin, USA Today, 9/29). Physicians who wish to distribute the pill must be able to "accurately determine the duration of a patient's pregnancy and detect an ectopic pregnancy." They also must be capable of providing "surgical intervention in cases of incomplete abortion or severe bleeding" or must plan in advance to have others available to provide such care (HHS release, 9/28).
Will it Really Be Available?
Though Danco Laboratories will make mifepristone available to doctors within about four weeks, how soon women will be able to obtain the drug will be determined by several factors, including which providers elect to administer it and when they decide to offer it; how much it will cost; and state laws that restrict access. "Each state has its own laws governing abortion provision, and we haven't had big time medical abortion in this country before," Dr. Carole Joffe, a University of California-Davis professor studying U.S. abortion policy, said (Fodor, Reuters Health, 9/28). The Center for Reproductive Law and Policy notes that mifepristone "is subject to the same laws that many states have enacted which restrict women's access to surgical abortion, including prohibitions on public hospital abortions, parental notification laws, skewed counseling and mandatory delay requirements ... most [state laws] do not distinguish between medical and surgical abortion, and may apply equally to those procedures." The CRLP adds that parental notification and consent laws are in effect in 31 states, and "physician only" laws, which prohibit non-physicians from performing abortions, are in effect in 43 states and may "apply to health providers who assist with medical abortion." In addition, 14 states enforce "targeted regulation of abortion provider laws [that] may force doctors interested in offering patients medical abortion to comply with burdensome regulations faced by surgical abortion providers" (CRLP release, 9/28).
A recent Kaiser Family Foundation poll revealed that 44% of obstetricians, gynecologists and family practice physicians said they would be "likely to offer the pills" if approved by the FDA; currently, only one-third of that number perform surgical abortions. Experts predict that more physicians will become involved in providing medical abortion "because the option will appeal to many women." The only "caveat" limiting the drug's appeal to providers is the FDA's requirement that "a doctor using the drugs be trained to operate in the rare event that surgical abortion is needed to finish the job -- or that he or she makes advance arrangements with a doctor who is," the Los Angeles Times reports. Dr. William Parker, a Santa Monica, Calif.-based OB/GYN, said, "If you are not comfortable doing a [surgical abortion], you are not going to be comfortable using a pill in which you might have to do a [surgical abortion]. I just don't think may doctors will want to offer it" (Cimons/Roan, Los Angeles Times, 9/29). Writing in a New York Times op-ed, Cynthia Gorney, author of "Articles of Faith: A Frontline History of the Abortion Wars," also sums up the myriad factors that may discourage women from opting for medical abortions: "Two visits to the doctor, under the most lenient of the current protocols -- maybe three visits -- and maybe a mandatory ultrasound to confirm the timing of the pregnancy, which could require a trip to a facility with an ultrasound machine. There's drawn out pain, severe in some cases, less so in others, but lasting considerably longer than the brief intense pain of most surgical abortions. And medical abortion promises to be no cheaper than the surgical alternative, at least at first ... according to doctors who have been running this country's clinical trials," Gorney writes (Gorney, New York Times, 9/29). However, the Los Angeles Times interviews an unnamed woman who received two abortions, one medical (through a clinical trial) and one surgical, and preferred the medical option because of "the ability to do it privately and not have to confront picket lines at a clinic." Furthermore, the surgical procedure was "invasive and emotionally distressing. The whole idea of anesthesia and someone taking you home from a doctor's office made it a much more complicated scenario. You feel more in control [with the pill]," she said (Los Angeles Times, 9/29). Gloria Feldt, current president of Planned Parenthood, estimated that about 20%-30% of women seeking abortions will use the pill (Galewitz, AP/Contra Costa Times, 9/28).