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See also FDA “Office Memo to Population Council,”www. Mifepristone approval delayed, supporters look to action by FDA,” Contraceptive Technology Update, Vol. Progesterone stimulates the proliferation of the uterine lining which nourishes the developing child.

Population Council “Medical Abortion with Mifepristone and Misoprostol: Frequently Asked Questions,” www. Because of the looser regulations, physicians considering prescription of RU486 no longer need to worry about getting special training, buying expensive medical equipment, or disrupting their medical practices. While Christin-Maitre, et al, specifically referred to the efficacy of mifepristone among women 49 days pregnant or les, Ulmann, Scientific American, p. The factory has been identified as a source of tainted drugs shipped to the U.

Williams, “Reunited Germany Divided Over Abortion Rights Issue,” Los Angeles Times, July 18, 1999, p. Carlyle Murphy, “Abortion Pill Dispute May Delay Debut,” Washington Post, June 11, 1997, p. Gina Kolata, “Wary Doctors Spurn New Abortion Pill,” New York Times, November 14, 2000, p. 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.

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Debra Rosenberg, Michelle Ingrassia, and Sharon Begley, “Blood and Tears,” Newsweek, p. Marc Kaufman, Washington Post, March 23, 1999. At least one out of every 100 women in the trials had to be hospitalized. Sarah Lueck, “Groups Offer Abortion-Drug Variations,” Wall Street Journal, October 30. John Sullivan, “Another Delay in Store for French Abortion Pill on U. It isn’t clear whether the Chinese formula for RU486 is the same as the one tested and approved in the U.

FDA, “Mifepristone Medication Guide,” available at www. Only then, after having already performed his “experiment” on 126 women, does the paper indicate Hausknecht decided to comply with the FDA’s wishes. Even where the abortion pill has full government approval, supply, training, and distribution issues still remain to be worked out, a task made all the more difficult in those countries with institutional opposition and complex nationalized health care bureaucracies. PG abortion method comes with a long list of contraindications, i.

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French manufacturer Roussel Uclaf to submit a marketing application. Planned Parenthood Federation of America, Inc. While still being asked to date pregnancies and diagnose ectopic pregnancies, prescribers are no longer required to conduct or read ultrasounds to confirm their diagnoses. Morning after pills, or “emergency contraception,” are essentially very high, multiple dosages of birth control pills taken within 72 hours of unprotected intercourse. With annual abortions now running about 1.

Advances in Health Technology, the non-profit which originally held the license for manufacturing and distributing mifepristone, was eliminated and replaced by a new company Advances for Choice, headed by Dutch former pharmaceutical executive Jack Van Hulst. See comment of Mary Jo O’Sullivan, MD, Reproductive Health Drugs Advisory Committee member, U. Hualian was detained by FDA officials in Cincinnati in July of 2000 because of false or misleading labeling. The Neogen Group, at meeting Towards Safe and Effective Use of Medical Abortion, sponsored by Population Council and Wellcome Trust, Bermuda, January 10-13, 1998, p. Owing to this lack of publicity, few women appreciate the level of risk involved in taking RU486. See also Sherry Kay Stolberg, “FDA Adds Hurdles in Approval of Abortion Pill,” New York Times, June 8, 2000.

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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 abortifacient capacity. Shari Roan, “Abortion Pill Is Safe in First Year of Use in U. Sophie Christin-Maitre, Phillippe Bouchard, and Irving Spitz, “Medical Termination of Pregnancy,” New England Journal of Medicine, Vol. Those same researchers recommend that the drugs be used cautiously in women with complicated diabetes mellitus, severe anemia, hemorrhagic disorders, or receiving treatment with anticoagulants.

Kaiser Family Foundation, Release, “One in Three Gynecologists Who Do Not Now Perform Abortions Would Offer Mifepristone,” June 8, 2000. In an earlier letter, Searle Vice President Charles L. 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. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,”New England Journal of Medicine, Vol. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. AP reporter Paul Recer’s wire story, “Abortion Pill,” AP Financial, October 13, 2000.

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FDA release, “FDA Approved Mifepristone for the Termination of Early Pregnancy,” September 28, 2000, available at www. Marc Kaufman, “Abortion Pill Inches Closer to Production,” Washington Post, Health p. See comments of Henderson, Sullivan, FDA Hearling, pp. 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. 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. New England Journal of Medicine, Vol.

Roussel Uclaf is the French pharmaceutical company which first developed RU486 in the early 1980s. FDA Talk Paper T00-18, February 18, 2000. The rest who aborted did so at some point during the following two weeks. Physicians now only have to sign a paper saying they have read and understood the prescribing instructions, indicate an ability to date pregnancy and diagnose ectopics, make arrangements for surgical backup, and assure patient “access” to relevant emergency services. Congress passed legislation creating the rules now reflected in the “Subpart H” provision in 1992 as part of an effort to streamline the approval process for AIDS drugs that were being delayed from reaching the market by what many considered excessively lengthy and overly cautious safety analyses.

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RU486’s acceptance in other nations around the globe who look to America for guidance. World Report, February 28, 2000, pp. An interpreter explained to the FDA inspector that Hualian had simply “copied information from the Roussel NDA in a number of sections rather than translate their own methods from Chinese to English.

Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions. Pike, filed in Supreme Court of the State of New York County of New York, Case No. For an earlier reference, see W. 13, both in Towards Safe And Effective Use of Medical Abortion, Population Council Conference, Bermuda, January 10-13, 1998, pp. Kim Bolan, “French abortion pill tested in Vancouver,” Vancouver Sun, July 7, 2000.

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Market,” New York Times, June 13, 1997, p. The dropping of the ultrasound requirement saves a doctor the expense of buying an ultrasound machine and undergoing special training or hiring new staff to conduct or read ultrasounds. Hualian’s willingness to disclose deficiencies or possible problems. National Abortion Federation, “Early Medical Abortion with Mifepristone or Methotrexate: Overview and Protocol Recommendations,” October 2000, p. The pill’s promoters have reason to believe RU486 will help them increase the number of doctors willing to perform abortions.

Pike, filed in Court of the State of New York County of New York, Case No. Christine Russell, “Percentage of Physicians Doing Abortions Declines,” Washington Post, September 23, 1995, p. Roussel Uclaf, which gave away the U. Accelerated Approval,” Federal Register, 57 FR 58942, December 11, 1992. Over a hundred women in the U.

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AP report, “Abortion pill study being run surreptiously,” Richmond Times-Dispatch, October 28, 1994, quoting C. Drug Maker,” Los Angeles Times, May 5, 1995, p. It certainly isn’t safe for the baby who suffocates or starves to death. Those countries were Austria, Belgium, Denmark, Finland, Germany, Greece, Spain, and The Netherlands. Exelgyn, to handle manufacturing, marketing and distribution of the drug. Mark Louviere, Transcript of FDA Reproductive Health Drugs Advisory Committee meeting, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy,” July 19, 1996, pp.

Chemical Works of Gedeon Richter, Case No. In 1998, a study by the California Department of Health Services found high levels of contaminants in an herbal medication made by Hualian’s earlier incarnation, the Shanghai No. Heavy bleeding, nausea, vomiting, and painful uterine contractions are common features of a process TIME magazine calls “A painful, messy, and protracted.

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Information published in trade and medical journals indicates that the FDA has sought to get Searle to change its label to endorse this use. While that may seem like a lot, big pharmaceutical companies often demand far more. Associated Press, “Iowa ‘abortion pill’ test heralded as a success,” Des Moines Register, September 2, 1995. At a minimum, the RU486 procedure involves two drugs and three trips to the doctor’s office over a two week period. Will the current regulations protect women’s safety? Caryle Murphy, “Abortion Pill Dispute May Delay Debut,” Washington Post, June 11, 1997, p.

Rebekah Saul, “The Political Challenges And Educational Opportunities Around Very Early Abortion,” The Guttmacher Report, February 1999, p. While none of the modifications appear to make things any safer for women or their babies, these less stringent rules do make things easier on the doctors and easier on their pocketbooks. Elyse Tanouye, “Hoechst Unit Plans to Acquire Stake in Copley,” The Wall Street Journal, October 11, 1993, pp. See also Vincent Rue, Anne Speckhard, James Rogers, and Wanda Franz, “The Psychological Aftermath of Abortion: A White Paper,” presented to C.

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Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Memorandum, Approval of Mifepristone, September 28, 2000, p. Despite enormous media hype and claims by the abortion industry that there is great demand for the drug, all available evidence indicates that RU486 has not been the breakthrough product the pills supporters dreamed of. André Ulmann, Georges Teutsch, and Daniel Philbert, “RU486,” Scientific American, Vol. 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.

Population Council’s marketing application to the FDA in 1996, supplying the Chemical, Manufacturing, and Control section of the Council’s marketing application, because the Council had yet to sign a firm contract with a manufacturer or obtain any product samples from a new manufacturing source. Those failing to abort will either face the added risk of surgery or the risk of giving birth to a baby whose development may have been affected by the drugs. Brad Evenson, “Abortion pill headed for Canada,” National Post, July 17, 1999.