RU-486 Regulation

 

Background: On September 28, 2000, the Food and Drug Administration (FDA) approved a regimen for using the drug RU-486, also called mifepristone or Mifeprex, to cause abortions within 49 days since the beginning of the last menstrual period. Mifepristone may be used in combination with the prostaglandin misoprostol or Cytotec. The drugs disrupt the uterine lining and cause the unborn child’s expulsion from the mother’s uterus. Using RU-486 typically involves three visits to a physician’s office or clinic. Danco Laboratories in New York is distributing mifepristone in the U.S.

House: On January 29, 2003, Rep. David Vitter (R-LA) introduced the RU-486 Patient Health and Safety Protection Act (H.R. 486). This bill was identical to a measure Rep. Vitter introduced in the 107th Congress. H.R. 486 had 42 cosponsors and was referred to the Health Subcommittee of the House Energy and Commerce Committee. No further action was taken. This measure would require the federal government to modify its approval of RU-486: the drug could be prescribed only by a licensed physician who is qualified to handle complications from incomplete abortions or ectopic pregnancies, has been trained in surgical abortions, is certified for ultrasound use, has completed a program on the use of RU-486, and has privileges at a hospital one hour or less away.

Executive: On April 19, 2002, at the urging of the FDA, Danco Laboratories sent a letter to health care providers informing them that six women had become seriously ill after taking mifepristone with misoprostol, with two of the women dying. The illnesses included: three ruptured ectopic pregnancies (one death), two systemic bacterial infections (one death), and one heart attack. The abortifacient drug combination should not be used when ectopic pregnancies are present. Danco declined to release figures on how many women in the U.S. have had abortions with the abortifacient drug combination. In its “Mifepristone Questions and Answers” document released April 17, 2002, the FDA stated that it is unknown whether there is a causal relationship between the illnesses and the use of mifepristone and misoprostol. In the six cases where illnesses occurred, misoprostol was given vaginally, not orally, which is the approved regimen. FDA said the use of mifepristone with misoprostol was safe but not risk free, if used as directed. In response to the question whether FDA is considering withdrawing mifepristone from the market, the FDA stated: “As it does with all prescription drugs, FDA continues to monitor the safety and effectiveness of mifepristone.” See: www.fda.gov/cder/drug/infopage/mifepristone.

On November 15, 2004, the FDA announced that it would require Danco Laboratories to add new health warnings on its label for RU-486. This action was prompted by news of another women’s death from sepsis associated with the use of RU-486. “FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA.”

Responding to the FDA announcement, Cathy Cleaver Ruse, spokeswoman for the Bishops’ Pro- Life Secretariat, stated, “RU-486 doesn’t need a better label, it needs to be shelved.” She added, “Young women depend upon the safety of FDA-approved drugs. How many have to die before this killer drug is taken off the market?” Ruse noted that RU-486 drug trials in Canada were suspended in 2001 following the death of a woman from septic shock.

On August 20, 2002, Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists, and the Christian Medical Association filed a formal legal petition with the FDA in which they outlined the numerous violations the FDA committed in approving RU-486 and how these violations resulted in the injury and death of women. They requested that the approval of RU-486 be revoked. The petition, 92 pages in length, cites some 9,000 pages of documents released by the FDA on January 31, 2002 as the result of a Freedom of Information Act request filed by Judicial Watch. In an August 21, 2002 press release, “Bishops’ Official Applauds Petition Against FDA’s RU-486 Approval,” spokesperson Cathleen Cleaver Ruse stated, “For the good of women and children, Mifeprex should be withdrawn immediately.”