RU-486 Q&A

What is RU486?

RU 486 is a chemical compound that, taken in pill form, can induce abortion in women up to nine weeks pregnant. This compound gets the first part of its name from the French company, Roussel Uclaf, which first developed the abortion pill back in 1980. The “486” designation is the shortened version of the original “38486” compound number the pill was first assigned in the Roussel Uclaf laboratory.1

RU486 is also known by its generic name, mifepristone, and by Mifegyne, the name under which RU486 is marketed in Europe. 2 “Mifeprex,” is the name under which it is to be sold in the United States,3 though it will also be marketed as the “Early Option” pill.4

How does RU486 work?

RU486 is an artificial steroid that interferes with the action of progesterone, a hormone crucial to the early progress of pregnancy. 5 Progesterone stimulates the proliferation of the uterine lining which nourishes the developing child. It also suppresses normal uterine contractions which could dislodge the child implanted and growing on the wall of the mother’s womb.6

RU486 fills the chemical receptor sites normally reserved for progesterone, but does not transmit the progesterone signal. Failing to receive that signal, a woman’s body shuts down the preparation of the uterus and initiates the normal menstrual process. The child, deprived of necessary nutrients, starves to death. The baby detaches and is swept out of the body along with the decayed uterine lining. 7

Is this the “morning after” pill I’ve heard so much about?

No. Those pills operate in a different way and during a different time frame than RU486.

Morning after pills, or “emergency contraception,” are essentially very high, multiple dosages of birth control pills taken within 72 hours of unprotected intercourse.8 , 9

While there have been some limited tests of RU486 as a morning after pill, with mixed results, 10 the only purpose for which the U.S. sponsor has sought government approval is for use to abort a confirmed pregnancy 11 , 12 weeks after the baby has already attached himself or herself to the uterine wall.13

What is the baby like at this time?

During the time frame that RU486 is operative, the baby is undergoing a rapid period of development.

It is at about the fifth week of pregnancy (measured from a woman’s last menstrual period) that a mother first begins to suspect she is pregnant, so this is likely to be about the earliest that the chemical abortifacient is used. At this point, the child is about three weeks old 14 and approximately 2mm long (about 1/10 of an inch). 15 Even by this time, however, the baby’s nervous system has begun to form 16 and his or her heart is likely to have already begun its first beats. 17 The child’s heart will be beating strongly and steadily by the time he or she is just three and a half weeks old.18

The effectiveness of the RU486, or mifepristone, method begins to decline after 49 days, or 7 weeks of pregnancy. 19 By that time, the baby will be five weeks old and will have increased in size to 8mm, and his or her face, arms, and legs will be distinguishable.20

Before the end of the 9th week of pregnancy (7 weeks for the baby), the outer extreme of mifepristone’s effectiveness, 21 the child’s ears, fingers and toes will have formed and he or she will be 18mm, or nearly an inch tall, from crown to rump.22

Does RU486 have any other, non-abortifacient, uses?

While researchers have proposed a long list of diseases and conditions that RU486 might be useful against, and in some cases, conducted limited testing, the only purpose for which the U.S. sponsor has pursued government approval is abortion.23

Because of its properties as a antiprogestin (a compound that inhibits the action of the hormone progesterone), some believe that it may be helpful in treating endometriosis, fibroids, breast cancer, and certain non-malignant brain tumors called meningomas.24 Pro-life groups such as the National Right to Life Committee have never opposed the testing or use of RU486 for such therapeutic purposes, but evidence of its effectiveness in these applications, 25 as well as evidence of the pill’s promoter’s real interest in such applications, is limited.26

Why does a typical RU486 abortion involve a second drug, misoprostol?

Acting alone, RU486 is able to induce an abortion only between 64% and 85% of the time, a rate abortifacient researchers consider “inadequate for general clinical use.” 27 This is why, two days after taking the RU486, a woman is given a prostaglandin, usually misoprostol (trade name: Cytotec), to induce powerful uterine contractions to expel the shriveled corpse.28 Because the use of a prostaglandin (PG) is part of the standard RU486 abortion protocol, it is perhaps more accurate to refer to this as an “RU486/PG” abortion.

How long does a typical RU486/PG abortion take and how many steps does it involve?

An RU486/PG induced abortion can take days, weeks, or never happen at all. It typically involves three (or more) visits to the doctor’s office over a two week period.

In her first visit, a woman is “counseled,” given a physical examination, perhaps an ultrasound, and if there are no obvious contraindications (common red flags such as high blood pressure, diabetes, heavy smoking, allergies, etc. that could make taking the drug deadly or dangerous for her 29 ), she is given the RU486 pills, which she takes in the presence of the abortionist.

Two days later, during a second visit to the doctor’s office, she is given the prostaglandin, which she takes orally or has inserted vaginally. Gradually, as the drug begins to take effect, she experiences powerful, painful uterine contractions which begin to work to expel the baby.

In U.S. trials, about half (49%) aborted during the four hours they spent waiting in the doctor’s office following the administration of the prostaglandin. An additional 26% aborted sometime over the next 20 hours, on the bus ride home, at work, in the shower, etc. The rest who aborted did so at some point during the following two weeks. Between 8% and 23% (depending on how many weeks pregnant the mother was) never completely aborted or didn’t abort at all using the drugs.

A third visit some 14 days from the woman’s initial visit allows the doctor to confirm whether or not the abortion has been completed. If it hasn’t, the abortionist will encourage the woman to undergo a surgical abortion to guard against the possibility that she will give birth to a child who may have been injured by the drugs.30 , 31

What sort of medical conditions might keep a woman from being offered the chemical abortion method?

Despite public claims of its ease and safety, the RU486/PG abortion method comes with a long list of contraindications, i.e., conditions that doctors believe should disqualify a woman from using the method or should at least call for heightened caution and monitoring among those selecting patients and administering the drugs because of the increased medical risks faced by such women.

Abortion researchers have recommended that women with adrenal failure, severe asthma, or receiving long-term glucocorticoid therapy not be given the drugs. Those same researchers recommend that the drugs be used cautiously in women with complicated diabetes mellitus, severe anemia, hemorrhagic [bleeding or clotting] disorders, or receiving treatment with anticoagulants. A prostaglandin sometimes used with RU486, sulprostone, has been associated with heart failure in women who were over 35, obese, smokers, or had other cardiovascular risk factors, though these have not yet been reported with the prostaglandin misoprostol.32

Other conditions that previous researchers have considered sufficient grounds to exclude women from clinical trials of the drugs include high blood pressure, bronchitis, menstrual irregularity, fibroids, endometriosis, use of IUD or oral contraceptives (in past three months), history of problem pregnancy, current ectopic pregnancy, pelvic inflammatory disease, allergies, epilepsy, adrenal insufficiency, recent intake of steroid or anti-inflammatory medication, or a history of liver, stomach, or intestinal disease.33

The FDA declared RU486 “safe” and “effective.” Is it really?

It certainly isn’t safe for the baby who suffocates or starves to death.34 Furthermore, credulity is strained to label a drug that puts perfectly healthy women in the hospital and may not work nearly a quarter of the time in a “safe” or “effective” manner.35

Despite careful screening to eliminate all but the most physically ideal candidates, 2% of those participating in U.S. trials of RU486 hemorrhaged.36 One out of a 100 had to be hospitalized.37 Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions.38 In the broader, less regulated medical marketplace, outside the careful monitoring of a clinical trial, complications could be expected to be both more common and more serious, especially for those women who do not have immediate access to emergency care.39

While tests in France yielded a 95-96% “success” rate, 40 the success rate in American trials for the two drug procedure has been considerably lower. Women in their fifth week of pregnancy aborted 92% of the time, while women in their seventh week aborted 77% of the time.41 Outside the strict conditions of a clinical trial, reduced screening, monitoring, and compliance is likely to increase the “failure” rate.42

Claims of higher effectiveness and less frequent complications made since approval 43 have yet to be independently medically verified, though a higher incidence of pelvic infections has been reported.44

Didn’t an Iowa woman participating in the U.S. trials in 1994 nearly bleed to death?

Yes. According to Mark Louviere, the doctor who treated the woman, she lost between one-half to two thirds of her total blood volume and probably would have died if she had not had emergency surgery.45 The doctor came forward after reading a press report that the Iowa portion of the trials had ended with “no complications” among the 238 women there who took part in the test.46 “If near death due to the loss of half of one’s blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication,” Louviere told the Waterloo Courier, “I don’t know what does.” 47

What other physical side effects are common?

Nausea, diarrhea, vomiting, and painful cramping are quite often part of the package, and sometimes in clinical trials were themselves severe enough to put women in the hospital.48 Less frequent, but potentially more serious, are side effects such as infection 49 or heart palpitations.50

Are there any long term physical consequences?

This is simply unknown at this point. It is known that RU486 crosses the blood follicle barrier and gets into the follicular fluid surrounding a woman’s ripening eggs.51 What impact this will have on future pregnancies, or on children born later on, has not yet been adequately researched.

Are chemical abortions safer than surgical abortions?

Both chemical and surgical abortions have their risks, and it is not clear that they are directly comparable.

Promoters of the abortion pill often speak as if RU486/PG abortions are safer because they are earlier abortions.52 While it is true that earlier surgical abortions are safer than later surgical abortions, 53 owing to the increasing size of the baby and the increasing complexity of the surgical procedure, 54 it isn’t clear that early chemical abortions are necessarily safer than later surgical abortions. Because the methods are so different, this is like comparing apples and oranges.

With a surgical abortion, a woman faces the risks of cervical lacerations, 55 uterine or bowel perforations, 56 scarring, infection, and even permanent infertility.57 These risks, due to the surgical process itself, may be avoided in a chemical abortion (provided a woman is not in that 8%-23% for whom the method fails 58). But the woman undergoing a chemical abortion faces a whole new set of risks, ranging from hemorrhage 59 to heart failure, 60 typically not faced by the surgical patient.

Variations in the severity and frequency of these complications make it difficult to identify one method as safer than another. Significant injury or worse is possible with either method.

What about psychological after effects?

Though no long term studies have yet been done, the descriptions women give of their encounters with their aborted children raise great concern. Women who have undergone RU486/PG abortions talk about seeing tiny fists, eyes, or seeing their aborted babies laying in the toilet bowl or swirling in the shower drain.61 Counselors at abortion clinics indicate it is common for women to express a desire to bury the baby, to perform some sort of ceremony to deal with their strong feelings.62 These are hardly the reactions of women who consider this a blob of tissue.63

Whereas those who undergo surgical abortion only imagine what their unborn children look like and go through, women who have abortions with RU486 have vivid memories of their encounters with their children.64 And while giving the woman more control over her abortion may assuage the abortionist’s guilt, it definitely increases a woman’s sense of responsibility for the abortion.65

While many women having surgical or chemical abortions feel a sense of relief immediately after the abortion, the symptoms of post abortion trauma often do not show up until years later.66 When women who have had RU486 abortions begin to deal with their experience, they will have more vivid memories and a greater sense of responsibility to deal with than those who underwent surgical abortions.

What is the current status of RU486?

The U.S. Food and Drug Administration granted final marketing approval to RU486 on September 28, 2000.67 It is now available from physicians who meet the FDA’s requirements and order the pills from Danco Laboratories, the drug’s U.S. distributor.68

What are the conditions under which it may be prescribed?

The FDA has mandated that the drug be made available to women who are no more than 49 days pregnant (7 weeks from their last menstrual period). Women taking the drug must sign a form indicating they are aware of the risks associated with the RU486/PG combination for them and their baby and promising to return for additional visits on day 3 (to take the prostaglandin) and about day 14 (to determine whether or not the abortion has taken place).69

Doctors prescribing RU486 are required to date pregnancies and diagnose ectopics. They also must be able, the FDA says, to provide “surgical intervention” in situations where there are incomplete abortions or severe bleeding, or to have in place arrangements for patients to obtain such services from other physicians who can perform these sorts of surgical procedures. Furthermore, the prescriber must “assure patient access to medical facilities equipped to provide blood transfusion and resuscitation, if necessary.”70

Physicians must also sign a form indicating they have read and understood the “prescribing information,” a detailed description of the RU486’s clinical pharmacology, the drug’s indications and contraindications, and relevant warnings and precautions. Included on this form are the prescribed protocol and failure and complication rates from French and U.S. clinical trials of the drug.71

The “prescriber agreement” further mandates that any hospitalization, transfusion, or “other serious event” is to be reported to Danco Laboratories, the supplier.72

What happened to the stricter regulations the FDA was considering back in June 2000?

Under pressure from pro-abortion groups 73 and many of their sympathetic allies in the medical establishment, 74 the FDA modified or set aside many of the patient protections considered just months before approval.75

While the FDA kept in place measures mandating strict distribution and monitoring of pills and continued to call for some limited follow up studies, 76 other regulations were scaled back or eliminated altogether.
Instead of special training in use of the drug, physicians now only have to certify that they have “read and understood the prescribing information” on RU486. While still being asked to date pregnancies and diagnose ectopic pregnancies, prescribers are no longer explicitly required to conduct or read ultrasounds to confirm their diagnoses.77

While the original regulations would have limited prescription of the drug to physicians who had the surgical training to handle incomplete abortions or serious complications sometimes associated with the drug, current measures require only that a physician not having such skills make arrangements with another physician with the appropriate surgical training.78

The rule that a doctor have admitting privileges at a hospital within an hour’s drive of his practice was replaced by a much looser requirement that asked only that the physician assure that a woman had “access” to appropriate medical facilities.79

Though the FDA decided against dropping the second visit to the doctor to take the prostaglandin on day 3, it did drop the requirement, in place during American trials of RU486, that women stay at the clinic for four hours after taking the prostaglandin.80

Who benefits from the FDA’s adoption of looser restrictions on RU486?

While none of the modifications appear to make things any safer for women or their babies, these less stringent rules do potentially make things easier on the doctors and their pocketbooks.

Because of the looser regulations, physicians considering prescribing RU486 no longer necessarily have to obtain special training, buy expensive medical equipment, or spend as much time monitoring their patients. This opens up the pool of potential prescribers not only to long time abortionists presumed to have surgical skills and experience in dealing with abortion complications, but to ob-gyns, family practitioners, pediatricians, and others no matter what their medical specialty or surgical training.81

The FDA’s decision to drop the ultrasound as an explicit requirement saves a doctor the expense of buying an ultrasound machine and undergoing special training or hiring new staff to conduct or read ultrasounds. Dropping the four hour wait that was once part of the second office visit in which the prostaglandin was given frees up office schedules, space, and bathrooms, making things more convenient for a doctor’s staff and more comfortable for other patients who might be troubled by what they see aborting women going through.82

The FDA’s decision to permit doctors to refer rather than treat patients for whom the method fails or causes problems doesn’t make things easier on the woman, who must figure out how to get to yet another address, but does allow the doctor to make complications or late night trips to the emergency room someone else’s problem.

What is the possible impact of these loose restrictions on the health of women taking RU486/PG?

There are real questions as to whether a doctor who has merely “read and understood” 83 prescribing instructions for RU486 really appreciates the medically complex, messy reality of chemical abortions.84Doctors with abortion experience were so surprised by the amount of blood lost in RU486/PG abortions in U.S. trials that the sponsor of the trials offered this as a possible explanation of lower “success” rates (i.e., higher rates of incomplete abortions) in the U.S. than in France.85

The RU486/PG method drops off significantly in effectiveness after the 7th week of pregnancy 86 and is not an effective agent against ectopic pregnancies.87 With ultrasound, the foremost diagnostic tool for dating and locating pregnancy, no longer required, errors in dating and diagnoses are more likely.88 In the case of a missed date, an error could mean failure of the chemical method and the increased possibility of surgical intervention.89 In the case of a missed tubal pregnancy, an error could mean a ruptured fallopian tube (which itself could be mistaken for an abortion) and tragedy for the mother as well as child.90

The absence of a surgical training requirement means that a woman for whom the method fails or one who faces serious complications may have to rely upon the help of a stranger whose name and number lies on a crumpled piece of paper at the bottom of her purse. The removal of the four hour wait at her second visit means she may face the most painful and dangerous part of her abortion all alone, precisely when she could require the greatest help, support, and medical care.91

Though the FDA still requires that a doctor assure “access” to appropriate medical services, the FDA’s abandonment of the provision that a doctor practice within an hour of a hospital where he or she has admitting privileges means that even if the patient is able to get to an adequately equipped hospital in time, her doctor may not be there to get her in or to treat her. If an ER staff is unfamiliar with chemical abortions and doesn’t recognize the danger a woman may be in, she could bleed to death.92

What is the status of the prostaglandin used in conjunction with RU486?

The FDA has mandated that the prostaglandin misoprostol should be used in the second stage of the RU486/PG chemical abortion, 93 even though this use contradicts instructions on misoprostol’s FDA sanctioned label.

The prostaglandin misoprostol is sold by pharmaceutical maker R.G. Searle, now part of Pharmacia, under the trade name Cytotec. Searle brought Cytotec to the market in 1988 as a special anti-ulcer medication for those, such as those suffering from arthritis, who take a lot of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin. Searle’s FDA approved label, from the beginning, has stated that the drug is contraindicated for, or not to be used by, pregnant women because of its capacity to induce miscarriage.94

In a 1993 letter to the Wall Street Journal, Searle said directly that it did not want its product used with RU486 for abortion, a position it has never, as far as is known, publicly altered.95

When the FDA approved RU486, however, in September of 2000, it specifically mandated the use of misoprostol as a necessary part of the chemical abortion procedure.96 earle never sought approval for this use, and its label (package insert) is inconsistent with this use.

Information published in trade and medical journals indicates that the FDA has sought to get Searle to change its label to endorse this use.97 If the FDA is successful in pressuring Searle to make such a change, the FDA will force Searle to accept a use of its product it finds objectionable, which could expose serious liability.

With all of the documented problems, why did the FDA recommend the approval of RU486 in the first place?

Good question. Under the first Bush administration, the FDA issued an import alert, prohibiting the import of the drug for personal use because of safety concerns of the drug.98 Three days after being sworn into office, President Bill Clinton signed an executive order directing the Department of Health and Human Services and the FDA to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S.99

Under the Clinton administration, the FDA took a very active role in efforts to bring the drug into the U.S. In the course of carrying out the president’s directive, the FDA:

Does the drug approval process usually work this way?

Hardly. The Food and Drug Administration is supposed to be an objective agency representing the health and safety interests of the American people, 107 not an agent for a manufacturer or group with an ideological or political agenda.

Was there anything suspicious about the timing of the approval?

Final government approval for RU486 came just over a month prior to the heavily contested 2000 U.S. presidential election, and close to the end of President Clinton’s last term in office.108

Bill Clinton initiated the process on January 22, 1993 when, just three days into his first term of office, he signed an executive order directing the FDA and the Department of Health and Human Services to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S.109

Though compilation of U.S. trial data was still incomplete, the FDA accepted a marketing application for the drug and brought it up for a hearing in 1996, the year Clinton was running for a second term.110 Though it did not grant final approval at the time, owing to then unresolved labeling and marketing issues, Clinton’s FDA did declare RU486 “approvable” in September of 1996, in the closing months of the 1996 presidential campaign contest.111

Is RU486 being manufactured by a foreign company?

Yes. Press accounts have confirmed that the RU486 being sold in the United States is being made by the Hualian Pharmaceutical Company, a state-owned drug manufacturer located on the outskirts of Shanghai in Communist China.112

What sort of problems does the drug’s being manufactured in China create?

Members of the U.S. government have expressed special concerns about drug manufacturing in the Far East and the FDA’s ability to monitor these manufacturers.113 The political, cultural, and geographic distance presents problems, not just for inspectors monitoring the integrity of manufacturing, storage, and shipping practices, but also for those seeking information for suits or compensation for injuries.114

Is the pill manufactured in China the same as the one made in France?

It is unclear whether the Chinese formula for RU486 is the same as the one tested and approved in the U.S.115 If not, data from the U.S. trials of RU486, which used the French-made pill, 116 offer no reliable guide to the safety and efficacy of the Chinese product.

Why do abortion supporters want the abortion pill?

Abortion has become increasingly unpopular with doctors, women, and the American public.
Ostracized by the medical community and worn out by thousands of abortions, many doctors are dropping abortion from their practice and fewer doctors are taking their places.117 Women use words like “intimidating,” 118 “invasive,” “mechanical,” “impersonal,” “abrupt,” 119 and “traumatic,”120 to describe their abortion experiences. Increasing majorities, while perhaps not yet ready to proscribe all abortions, nevertheless see abortion as murder or at least the taking of human life, and something that should be limited.121

Chemical abortions, like RU486/PG, give supporters of abortion a chance to change the image of abortion, making it seem as simple as taking a pill 122 and concentrating on smaller, less developed babies whose destruction seems an easier political sell.123 The reality is far different – these abortions offer a whole new set of significant risks, and the objective is still the destruction of a unique human life. These truths are of little consequence to abortion’s promoters as long as their false perception holds.

Source: National Right to Life, www.nrlc.org.

  1. Etienne-Emile Baulieu, The “Abortion Pill” (New York: Simon & Schuster, 1991), p. 25.
  2. Baulieu, p. 191.
  3. U.S. Food and Drug Administration, “Mifepristone Label,” available at www.fda.gov/cder/foi/label/2000/20687lbl.htm.
  4. Rachel Zimmerman, “Awaiting Green Light, Abortion-Pill Venture Keeps to the Shadows,” Wall Street Journal, September 5, 2000. Stacey Schultz, in an earlier report, (“Long-awaited abortion pill will offer more privacy – but no less controversy,” U.S. News & World Report, February 28, 2000, p. 79), gave the trade name of the drug as “Mifeprex.”
  5. André Ulmann, Georges Teutsch, and Daniel Philbert, “RU486,” Scientific American, Vol. 262, No. 6 (June 1990), pp. 18-24.
  6. Arthur C. Guyton, Textbook of Medical Physiology, 6th ed., (Philadelphia: W.B. Saunders Co., 1981), p. 1012.
  7. Baulieu, pp. 13, 16-18; Ulmann, pp. 18-20.
  8. Planned Parenthood Federation of America, Inc., Emergency Contraception Handbook, Planned Parenthood booklet, 1999, pp. 8-9, 11.
  9. Robert A. Hatcher, et al, Contraceptive Technology, 16th rev. ed. (New York: Irvington Publishers, 1994), pp. 453, 455, 459, 461.
  10. A Psychosos, et al, “Hormonal anti-implantation agents: antiprogestins,” Human Reproduction Vol. 10, supplement 2 (December 1995), pp. 140-150; I.M. Spitz, et al, “Effect of mifepristone on inhibition of ovulation and induction of luteolysis,” Human Reproduction, Vol. 9, supplement 1 (June 1994), pp. 69-76; I.M. Spitz, A. Robbins, “Mechanism of action and clinical effects of antiprogestins on the non-pregnant uterus,” Human Reproduction Update, Vol. 4, No. 5 (September-October, 1998), pp. 584-593; Task Force on Postovulatory Methods of Fertility Regulation, “Comparison of three single doses of mifepristone as emergency contraception: a randomised trial,” Lancet, Vol. 353 (February 27, 1999), pp. 697-702.
  11. Reproductive Health Drugs Advisory Committee, U.S. Food and Drug Administration, Transcript, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy,” (available from CASET Associates, Fairfax, Virginia); PPFA, Emergency Contraception Handbook, p.22.
  12. Irving M. Spitz, et al, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), p. 1242.
  13. Keith L. Moore, The Developing Human, 4th ed. (Philadelphia: W.B. Saunders Co., 1988), p.2.b
  14. Keith L. Moore, The Developing Human, 3rd ed. (Philadelphia: W.B. Saunders, 1982), p. 94.
  15. Lennart Nilsson and Lars Hamberger, A Child is Born (New York: Delacorte Press, 1990), p. 77.
  16. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed. (Philadelphia: W.B. Saunders, 1993), pp. 385-386.
  17. LIFE Educational Reprint #27, “Life Before Birth,” p. 6. Reprinted from LIFE, April 30, 1965.
  18. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed., p. 65.
  19. Irving M Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), p. 1243.
  20. Moore and Persaud, The Developing Human, 5th ed., p. 3.
  21. Spitz, et al., “Early Pregnancy Termination…”, p. 1243.
  22. Moore and Persaud, The Developing Human, 5th ed., p. 4.
  23. See transcript of FDA Mifepristone Hearings, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy.”
  24. Committee on Antiprogestins, National Academy of Sciences, Clinical Applications of Mifepristone (RU486) and Other Antiprogestins (Washington, D.C.: National Academy Press, 1993), pp. 36-51.
  25. F. Darro, et al, “Growth inhibition of human in vitro and mouse in vitro and in vivo mammary tumor models by retinoids in comparison with tamoxifen and the RU-486 anti-progestagen,” Breast Cancer Res Treat, Vol. 51, No. 1 (September, 1998), pp. 39-55; W.G. Schoonen, et al, “Effects of two classes of progestagens, pregnane and 19-norestosterone derivatives, on cell of human breast tumor cells: II. T47D cell lines,” Journal of Steroid Biochem and Mol Biology, Vol. 55, Nos. 3-4 (December 1995), pp. 439-44; L.M. Kettel, et al, “Preliminary report on the treatment of endometriosis with low-dose mifepristone (RU486),” American Journal of Obstetrics and Gynecology, Vol. 178, No. 6 (June 1998), pp. 1151-1156.
  26. Regina Sitruk-Ware, in “Les antiprogesterones,” Presse Med, Vol. 28, No. 38 (December 4, 1999), pp. 2123-2131, talks about the use of RU486 for endometriosis, fibroids, and meiningomas, but focuses largely on abortion and labor induction properties examined in large clinical studies.
  27. Sophie Christin-Maitre, Philippe Bouchard, and Irving Spitz, “Medical Termination of Pregnancy,” New England Journal of Medicine, Vol. 342, No. 13 (March 30, 2000), p. 951. While Christin-Maitre, et al specifically referred to the efficacy of mifepristone among women 49 days pregnant or less when recounting these percentages, Ulmann, in Scientific American, p. 23, reported a range of 65% to 80% efficacy. Other studies using similar doses obtained “completion” rates of 65.2% (RU486 Collaboration Group, “Termination of early pregnancy by RU486 alone or in combination with prostaglandin,” Chinese Journal of Obstetrics & Gynecology, Vol. 25 (1990), pp. 31-4, 62) and 63.5% (Zheng Shu-rong, “RU 486 (mifepristone): clinical trials in China,” Acta Obst. Gyn. Scand, Vol 149 (1989), supplement, pp. 19-23.
  28. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbings, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1243.
  29. See the NRL-Educational Trust Fund fact sheet “RU486: Risks & Dangers,” for a full list of contraindications and references.
  30. Irving M. Spitz, C.Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998).
  31. Oregon Health Sciences University, “Consent Form” for “Evaluation of the Efficacy, Safety and Acceptability of Mifepristone and Misoprostol in Inducing Abortion in Pregnant Women with Amenorrhea of up to 63 Days” (ORS #3703, Protocol 166B), 12/1/94.
  32. Christin-Maitre, et al, “Medical Termination of Pregnancy,” pp. 952-953.
  33. Raymond, et al, RU 486: Misconceptions, Myths, and Morals, pp. 34-37; B. Couzinet, N. Le Strat, A. Ulmann, E-E. Baulieu, G. Schaison, “Termination of early pregnancy by the progesterone antagonist RU 486 (mifepristone),” New England Journal of Medicine, Vol. 315 (December 18, 1986), pp. 1565-70; L. Silvestre, C. Dubois, M. Renault, Y. Rezvani, E-E. Baulieu, A. Ulmann, “Voluntary interruption of pregnancy with mifepristone (RU486) and a prostaglandin analogue: a large-scale French experience,” New England Journal of Medicine, Vol. 322 (March 8, 1990), pp. 645-648.
  34. See comment of Mary Jo O’Sullivan, MD, Reproductive Health Drugs Advisory Committee member, U.S. Food and Drug Administration, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy,” transcript by CASET Associates (Fairfax, VA), p. 290.
  35. Spitz, et al, NEJM, pp. 1243-44.
  36. FDA Mifepristone Hearing, p. 65.
  37. Spitz, et al, NEJM, p. 1243.
  38. Spitz, et al, NEJM, p. 1243.
  39. See comments of FDA Reproductive Health Drugs Advisory Committee Member Cassandra Henderson, MD, at pp. 278-280, 291-292.
  40. FDA Hearing, pp. 28, 30-31.
  41. Spitz, et al, NEJM, p. 1243.
  42. See comments of Henderson, Sullivan, FDA Hearling, pp. 278-280, 291-292.
  43. Statement of Planned Parenthood, 9/24/01
  44. Shari Roan, “Abortion Pill Is Safe in First Year of Use in U.S., Proponents Say” Los Angeles Times, 10/1/01.
  45. Statement of Mark Louviere, MD, FDA Mifepristone (RU486) Hearing, 7/19/96, pp. 223-227.
  46. Associated Press, “Iowa ‘abortion pill’ test heralded as a success,” Des Moines Register, September 2, 1995, Metro section, p. 5.
  47. Tom Carney, “‘Abortion pill’ test goes awry for one patient,” Des Moines Register, Metro section, p. 1, 5.
  48. Spitz, et al, NEJM, pp. 1243-1245.
  49. Spitz, et al, NEJM, p. 1244.
  50. FDA Mifepristone (RU486) Hearings, pp. 50, 55.
  51. Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU486: Misconceptions, Myths and Morals, Cambridge, MA: Institute on Women and Technology, 1991, pp. 75-76.
  52. Testimony of Beverly Winikoff, Program Director of Reproductive Health, Population Council at FDA Mifepristone Hearings, p. 81; Margaret Talbot, “This Pill Will Change Everything About Abortion,” The New York Times Magazine, July 11, 1999, p. 41; Aaron Zitner, “What ever happened to RU-496?” The Boston Globe Magazine, November 23, 1997, p. 39.
  53. Jack Pritchard, et al, Williams Obstetrics, 17th ed. (Norwalk, CT: Appelton-Century-Crofts, 1985), p. 483.
  54. Warren M. Hern, Abortion Practice (Philadelphia: J.B. Lippincott, 1984), pp. 26-35.
  55. Kenneth F. Schulz, et al, “Measures to Prevent Cervical Injury During Suction Curettage Abortion, “The Lancet, May 28, 1983, p. 1182.
  56. Philip G. Stubblefield, “First and Second Trimester Abortion,” in Gynecologic and Obstetric Surgery, ed. David H. Nichols (Baltimore: Mosby, 1993), pp. 1023-1024; Stephen G. Kaali, et al, “The frequency and management of uterine perforations during first-trimester abortions,” American Journal of Obstetrics and Gynecology, August 1989, pp. 406-408.
  57. David N. Danforth, ed. Obstetrics and Gynecology, 5th ed. (Philadelphia: J.B. Lippincott, 1986), pp. 217, 257, 382-383, 887; Nichols, Gynecologic and Obstetric Surgery, p. 260; Pritchard, Williams Obstetrics, 17th ed., p. 484; Leon Speroff, et al, Clinical Gynecological Endochrinology & Infertility (Baltimore: Williams & Wilkins, 1983), pp. 156- 157.
  58. Spitz, “Early Pregnancy Termination…,” p. 1241.
  59. Spitz, “Early Pregnancy Termination…,” p. 1243; Statement of Mark Louviere, FDA Mifepristone Hearings, pp. 223-225.
  60. Alan Riding, “Frenchwoman’s Death Linked to Abortion Pill and a Hormone,” New York Times, April 10, 1991, p. A-10.
  61. Debra Rosenberg, Michelle Ingrassia, and Sharon Begley, “Blood and Tears,” Newsweek, p. 68. Louise Levanthes, “Listening to RU486,” Health, January/February 1995, p. 88.
  62. Judith Gaines, “Women describe pros, cons of RU486,” Boston Globe, May 8, 1995, p. 1.; “Prepare now to counsel patients on RU486,” Contraceptive Technology Update, April 1995, p. 53.
  63. Levanthes, p. 88-89.
  64. Levanthes, pp. 87-89; Gaines, p. 1; Rosenberg, pp. 66-68.
  65. Levanthes, p. 88; CTU, p. 52.
  66. Anne C. Speckhard and Vincent Rue, “Postabortion Syndrome: An Emerging Public Health Concern,” Journal of Social Issues, Vol. 48, No. 3 (1992), pp. 95-119. See also Vincent Rue, Anne Speckhard, James Rogers, and Wanda Franz, “The Psychological Aftermath of Abortion: A White Paper,” presented to C. Everett Koop, Surgeon General of the U.S., September 15, 1987. For an earlier reference, see W. L. Sands, “Diagnosing Mental Illness; Evaluation in Psychiatry and Psychology,” in Psychiatric History and Mental Status, eds. Freedman and Kaplan (Atheneum, 1973), p. 31.
  67. FDA “Approval Letter Mifeprex™ (mifepristone) Tablets,” September 28, 2000, available at www.fda.gov/cder/drug/infopage/mifepristone. FDA release, “FDA Approved Mifepristone for the Termination of Early Pregnancy,” September 28, 2000, available at www.fda.gov/bbs/topics/NEWS/NEW00737.html.
  68. FDA, “Office Memo to Population Council,” September 28, 2000, at www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf.
  69. FDA, “Patient Agreement” for Mifeprex (mifepristone) tablets, available at www.fda.gov/cder/drug/infopage/mifepristone/patientagreement.pdf.
  70. FDA, “Prescriber’s Agreement, for Mifeprex (Mifepristone) Tablets, available at www.fda.gov/cder/drug/infopage/mifepristone/patientagreement.pdf.
  71. FDA, “Prescriber’s Agreement, for Mifeprex (Mifepristone) Tablets, available at www.fda.gov/cder/drug/infopage/mifepristone/patientagreement.pdf.
  72. Danco Laboratories, “Prescribing Information,” Mifeprex Early Option Pill packet, available from Danco Laboratories, P.O. Box 4816, New York, NY 10185, or from FDA website at www.fda.gov/cder/drug/infopage/mifepristone (comprised of “Mifepristone Label,” “Medication Guide,” and “Patient Agreement”).
  73. Jean Marbella, “FDA fuels abortion pill debate,” Baltimore Sun, June 12, 2000.
  74. Letter from American College of Obstetricians and Gynecologists and American Medical Association to Jane Henney, FDA Commissioner, July 24, 2000.
  75. Nancy Gibbs, “The Abortion Pill,” TIME, October 9, 2000, p. 43.
  76. FDA, “Mifepristone Approval Letter,” September 28, 2000, and FDA, “Office Memo to Population Council,” September 28, 2000.
  77. FDA, “Office Memo to Population Council,” September 28, 2000, at www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf, p. 5.
  78. FDA, “Office Memo to Population Council,” September 28, 2000, at www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf, p. 5.
  79. FDA, “Office Memo to Population Council,” September 28, 2000, at www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf, p. 5.
  80. FDA, “Office Memo to Population Council,” September 28, 2000, at www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf, pp. 2-3.
  81. Carole Joffe, “Medical Abortion and the Potential for New Abortion Providers: A Cautionary Tale,”Journal of the American Medical Women’s Association, Vol. 55, No. 3 (Supplement 2000), pp. 151-154. See also Sherry Kay Stolberg, “FDA Adds Hurdles in Approval of Abortion Pill,” New York Times, June 8, 2000.
  82. Carole Joffe, “Reactions to Medical Abortion Among Providers of Surgical Abortion: An Early Snapshot,” Family Planning Perspectives, Vo. 31, No. 1 (January-February 2000), pp. 35-38.
  83. FDA “Office Memo to Population Council,” www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf , p. 6.
  84. Carole Joffe, “Reactions to Medical Abortion Among Providers of Surgical Abortion: An Early Snapshot,” Family Planning Perspectives, Vo. 31, No. 1 (January-February 2000), pp. 35-38.
  85. Thomas H. Maugh II, “Abortion Drug Is Safe, U.S. Study Finds,” Los Angeles Times, April 30, 1998, p. A4.
  86. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1247.
  87. Mifeprex label, available at www.fda.gov/cder/foi/label/2000/20687lbl.pdf Also see O.M Avrech, et al, “Mifepristone (RU486) alone or in combination with a prostaglandin analogue for termination of early pregnancy: a review,” Fertility & Sterility, Vol 56 (1991), pp. 385-293.
  88. Maureen Paul, et al, A Clinician’s Guide to Medical and Surgical Abortion (New York: Churchill Livingstone, 1999), pp. 41, 50.
  89. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,”New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1247.
  90. F. Gary Cunningham, et al, “Chapter 32: Ectopic Pregnancy,” Williams Obstetrics, 19th ed. (Norwalk, CT: Appleton & Lange, 1993), pp. 691-719, particularly, pp. 696, 705.
  91. FDA “Mifepristone Hearing” transcript of Reproductive Health Drugs Advisory Committee meeting, July 19, 1996, pp. 48-49. C. Wayne Bardin, the doctor who oversaw the new drug application for the Population Council, told the FDA advisory panel that 65% of all “adverse events” that were reported were observed during the 4-5 hours the women spent in the clinic after taking the misoprostol.
  92. The case of Dr. Mark Louviere, reported in the September 24, 1995 edition of the Waterloo Courier (p. F3), is instructive. Louviere’s patient was fortunate that he recognized her danger and rushed her to emergency surgery.
  93. Mifeprex Label, available at www.fda.gov/cder/foi/label/2000/20687lbl.htm.
  94. Michael A. Friedman, M.D., “Manufacturer’s Warning Regarding Unapproved Uses of Misoprostol,” New England Journal of Medicine, Vol. 344, No. 1 (January 4, 2001), p. 61.
  95. Charles L. Fry, Letter to the Editor, “Searle Against Use of Its Drug in Abortion,” Wall Street Journal, March 19, 1993, p. A11.
  96. Mifeprex Label, available at www.fda.gov/cder/foi/label/2000/20687lbl.htm.
  97. “Searle/FDA Cytotec Labeling Negotiations Continue Ahead Of Mifeprex Launch,” F-D-C Reports “The Pink Sheet,” October 9, 2000, p. 11.
  98. Import alert 66-47, Import Operations Branch, Food And Drug Administration, April 17, 1990.
  99. William J. Clinton, “Memorandum for the Secretary of Health and Human Services; Subject: Importation of RU-486,” January 22, 1993.
  100. David Kessler, FDA Commissioner, Letter to Roussel Uclaf President Edouard Sakiz, January 22, 1993; David Kessler, Letter to Wolfgang Hilger, CEO of Hoecht AG, February 3, 1993; Philip Hilts, “Door May be Open for Abortion Pill To Be Sold in U.S.” New York Times, February 23, 1993; “Battle Looms Over Abortion Pill,” Boston Globe, February 26, 1993; Associated Press, “Abortion Pill,” April 15, 1993.
  101. Letter, Department of Health and Human Services Secretary Donna Shalala to Representative Ron Wyden (D-OR), February 8, 1994; Roussel Uclaf, Press Release, May 16, 1994; Hearing, “RU-486, Status Report on the U.S. Commercialization Project, Transfer of Antiprogestin Technology to the United States,” Subcommittee on Regulation, Business Opportunities, and Technology, of the Committee on Small Business, U.S. House, Serial No. 103-80, May 16, 1994; Letter, Lester Hyman, of Roussel Uclaf, to FDA Commissioner David Kessler, May 20, 1994; Letter, Edouard Sakiz, president Conseil de Surveillance of Roussel Uclaf, to FDA Commissioner David Kessler, May 25, 1994.
  102. Letter FDA Commissioner David Kessler, to Roussel Uclaf President Edouard Sakiz, December 14, 1992;
  103. Danco v. Richter, filed in the Supreme Court of the State of New York, May 9, 1997, pp. 7, 9.
  104. Danco v. Richter, p. 9.
  105. Letter from Richard D. Glasow, Wanda Franz, Brian Lopina, Tom Minnery, J.C. Willke, Beverly LaHaye to FDA Commissioner David Kessler, July 10, 1996.
  106. “‘Priority’ NDAs approved ten months faster than standard applications – GAO Report to Kassebaum…” F-D-C Reports (“The Pink Sheet”), November 13, 1995, pp. 9-10.
  107. The FDA refers to itself as “The Nation’s Foremost Consumer Protection Agency” on its website at www.fda.gov and is the agency set up by Congress to monitor the safety of foods and medicines sold in the United States.
  108. FDA, “Press Release on Mifepristone Approval,” available at www.fda.gov/bbs/topics/NEWS/NEW00737.html.
  109. William J. Clinton, “Memorandum for the Secretary of Health and Human Services; Subject: Importation of RU-486,” January 22, 1993.
  110. Transcript of FDA Advisory Panel, “Mifepristone for…” July 19, 1996, p. ….
  111. FDA, “Approvable Letter for Mifepristone 9/18/96”.
  112. Philip P. Pan, “Chinese To Make RU-486 For U.S.,” Washington Post, October 12, 2000, p. A1.
  113. Letter from Rep. Tom Bliley (R-VA), Chair of the U.S. House Commerce Committee, to Jane Henney, M.D., FDA Commissioner, September 25, 2000.
  114. Rep. Chris Smith (R-NJ) raises this sort of concern in AP reporter Paul Recer’s wire story, “Abortion Pill,” AP Financial, October 13, 2000.
  115. Regina Sitruk-Ware, a representative of Exelgyn, the current French supplier, told a 1998 Population Council sponsored conference that the Chinese synthesis for the abortion pill is different from the one developed by the French and said only that the pills are “very similar.” See “Strategy for the introduction of Mifepristone,” Population Council and The Wellcome Trust Conference, Towards Safe and Effective Use of Medical Abortion, Bermuda, January 10-13, 1998, Report of Meeting, p. 16.
  116. Lawrence Lader, A Private Matter (New York: Prometheus Books, 1995), p. 227.
  117. Christine Russell, “Percentage of Physicians Doing Abortions Declines,” Washington Post, September 23, 1995, p. A3; Gina Kolata, “Under Pressures and Stigma, More Doctors Shun Abortion,”New York Times, January 8, 1990; Warren Hern, “Hunted by the Right, Forgotten by the Left,” New York Times, March 13, 1993, p. 21; Amy Goldstein, “U.S. Abortion Services Drop,” Washington Post, January 22, 1995, p. A1.
  118. Philip J. Hilts, “Clinic Trials of French Abortion Pill Begin in U.S.,” New York Times, October 28, 1994, p. A28.
  119. Judith Gaines, “Women describe pros, cons of RU486,” Boston Globe, May 8, 1995, p. 1.
  120. Andrea Sachs, “Abortion Pills on Trial,” TIME, December 5, 1994, p. 46. See also “Prepare now to counsel patients on RU486,” Contraceptive Technology Update, April 1995, p. 52.
  121. Between July of 1989 and January of 1998, the CBS/New York Times poll saw a shift from 40% to 50% of those calling abortion “murder;” those saying abortion was not murder dropped from 47% to 38% in the same time frame. A January 22, 1998 poll by CNN/Gallup/USA Today found 58% of all Americans believing that abortion should be legal only under certain circumstances and 17% holding abortion should be illegal in all circumstances – a total of 75% rejecting the current policy of abortion on demand.
  122. Sue M. Halpern, “RU-486: the unpregnancy pill,” Ms., April 1987, p. 56.
  123. Margaret Talbot, “This Pill Will Change Everything About Abortion,” The New York Times Magazine, July 11, 1999, p. 41; Kim Painter, “Earlier, easier abortions,” USA Today, August 4, 1999, p. D1; Rebekah Saul, “The Political Challenges And Educational Opportunities Around Very Early Abortion,” The Guttmacher
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