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Global Monitor: Contraceptive Watch: FDA Delays Approval of Abortion Pill

Dr. Wilke’s Questions Cause RU-486 Advocates to Retreat

The US Federal Drug Administration (FDA) handed pro-abortion activists a major setback last February when it delayed the approval of RU-486 (cytotec prostaglandin), the so-called “abortion pill.” In a short statement, the FDA said that there were questions that “need to be resolved before final marketing approval can be granted.”

Many of the “questions” about the abortion pill were generated by Dr. J.C. Wilke, President of the Cincinnati-based Life Issues Institute, Inc. At a recent gathering of conservative leaders in Washington, DC, Dr. Wilke presented “Some Important Questions for ‘RU-486’ Advocates” which were later distributed to members of Congress, the media and to the FDA, Dr. Wilke’s well-rounded list of questions, according to many pro-family leaders, played a critical role in stopping the forward momentum of the pro-abortion lobby.

Wilke’s questions include:

  • How often can a woman use RU-4S6? How will the abortionist guarantee truly informed consent among non-English speaking women?

  • What pre-existing health conditions will bar women from using RU-486?

  • Who is going to pay for the surgery and emergency room costs for the 5% of women who have incomplete abortions caused by failed RU-486.

  • What has happened to the babies of women who took RU-486 and still carried them to term? How many of these cases occur? If a baby is born with deformities caused by RU-486, who will pay?

  • How will the abortionist insure that a woman will return for mandatory follow up to check whether the drugs worked? How much training will the non-Ob/Gyns have before distributing RU-486?

  • Have there been any long-term medical studies about the medical and psychological consequences of RU-486?

  • How will the abortionist follow-up with teenagers who do not want to be called at home?

To date, these questions have gone unanswered by the FDA.

RU-486 causes abortion with a double-dose of chemicals. The first chemical blocks the action of progesterone, the hormone responsible for maintaining pregnancy. This prepares the body for a miscarriage which can then be triggered using another drug, a prostaglandin, taken two days later. Organizations like the World Health Organization (WHO) and the United Nations Population Fund (UNFPA) have been criticized for distributing the drug in refugee and disaster situations as a non-abortion inducing chemical, disguised as “humanitarian aid” to victims of ethnic rape. Last summer, PRI discovered UNFPA distributing “morning after” pills as a routine method of “family planning,” in apparent violation of internationally accepted norms of informed consent. In tandem with its RU-486 distribution, UNFPA distributed manual suction devices used to complete failed abortions caused by the pills. The UN’s I994 Cairo Programme of Action prohibits abortion promotion or provision. The National Abortion Rights Action League (NARAL) confirmed that “RU-486 is an effective non-surgical method of early abortion.”

The French company that developed RU-486 refused to market it in the States for fear of boycotts of its whole line of products, and no American pharmaceutical company was willing to buy the rights. Finally the Population Council obtained the rights to produce the drug, which it licensed to a new company, Danco Laboratories.

(Zenit, “FDA Delays Approval of RU-486,” 20 February 2000; PRI Review, “Refugees Rights vs. Reproductive Rights,” by Joseph Meaney, April / May 1999, 1; Life Issues Connector, “Some Important Questions for ‘RU-486’ Advocates,” January 2000, 5,; NARAL Factsheet, “RU-486 and the Impact of Abortion…,” 12 February 1996,

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