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FDA Sees Risks of RU-486

 

by Susan E. Wills

June 23, 2000

The pages of a day calendar flip, flip, faster and faster. Blown by the winds of time as months, then years go whizzing by.

Such was the clumsy device used in old movies to span a gap of years between scenes. And such must be part of a recurring nightmare of those eager to see RU-486 approved for use as an abortion drug in the United States. Their hope of getting it approved seemed assured on President Clinton's first day in office, when he signed an executive order asking federal agencies to expedite approval of the drug. Now more than seven years later—in the waning days of the Clinton Administration—supporters of RU-486 are facing another obstacle: reported Food and Drug Administration (FDA) restrictions on the distribution and use of RU-486. The window of opportunity is closing, for if the drug is not widely available before the president's term expires, the coming election could keep RU-486 out of the U.S. indefinitely.

All to the good, of course! Up to now the FDA's actions on RU-486 have been alarmingly supportive. The approval process was put on a fast track. A Citizen Petition citing safety concerns and requesting deliberate, careful review was all but ignored. Six of eight voting members on the FDA Reproductive Health Drugs Advisory Committee were enthusiastic proponents of the drug. The Committee's public review was hasty and shoddy— accomplished even before safety and efficacy data from U.S. drug trials were analyzed. The FDA issued a conditional approval letter in September 1996, despite the evidence of serious adverse side effects in U.S. trials. All that was needed was a manufacturer and agreement on labeling and manufacturing issues.

In the four years since conditional approval, periodic press releases from the Population Council and Danco Laboratories (holders of U.S. rights in RU-486) have announced that final FDA approval is imminent. So it came as a shock to abortion lobbyists and media when Danco leaked new proposed restrictions on RU-486. It seems that FDA officials finally examined safety and efficacy data from the U.S. trials, came to their collective senses and decided to challenge the rosy accounts of unqualified success churned out by Population Council's publicity machine.

According to press accounts, the FDA proposes that only doctors who perform abortions would be allowed to prescribe RU-486. Prescribing abortionists would be required to comply with the following: register with the drug's distributor; be trained in RU-486 use (and so certified by a third party); be trained in reading ultrasound scans to determine gestational age; and maintain admitting privileges at hospitals with emergency facilities no more than an hour from their offices. Follow-up studies on safety were also proposed.

In light of the serious, potentially life-threatening, risks RU-486 poses to women from incomplete abortion, infection and excessive bleeding, the restrictions are eminently reasonable. And while we can never condone the use RU-486 as an abortifacient because it kills a child, there is some small measure of relief that the FDA intends to contain the destructive potential of this deadly drug.

The media do not share our relief. Shock, outrage and betrayal characterize editorials lambasting the proposed restrictions. Why? If they were concerned about women's health it would make no sense. But, as their comments reveal, women's health is far from their primary concern. They support RU-486 for its potential to "end the abortion debate" forever. As one columnist put it, once RU-486 is approved, "this country can start putting this awful abortion fight behind us" (Mann, "We Need the Abortion Pill Now," The Washington Post, June 23, p. C9). Dr. Eric Schaff, a pediatrician involved in clinical trials, explained: "The whole idea of [RU-486] was to increase access. ... [The FDA proposal] kills the drug if it can't be used by primary care providers" (Stolberg, The New York Times on-line edition, June 8).

Immediately, abortion lobby groups met to strategize. They are reportedly considering an advertising campaign as well as a direct mail and lobbying effort directed at Congress. The House, for one, will not be receptive. It has twice passed a ban on the FDA's use of funds for approval of RU-486 or other abortifacient drugs. The provision failed in the Senate and was twice dropped in Conference. But its chief sponsor, Rep. Tom Coburn, has reintroduced it. And pro-abortion Members of Congress would be in a tough position if they intervened against the FDA action now, having objected to Coburn's earlier efforts on the ground that the FDA should be "left alone to reach its best scientific judgment" free of interference from Congress. Coburn notes that even with the high level of government oversight in Europe regarding the administration of RU-486, still one in 40 women have an incomplete abortion which can lead to infection and death. In the unregulated health care environment of the U.S., he is concerned that "it might become an 'underground' drug used by frightened young women without proper medical supervision, and end up killing many of them."

The FDA has set a deadline of September 30 for final approval, rejection or continuance. 



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