The FDA's approval last fall of the controversial abortion drug RU-486 presents a danger to American women and children and should be reviewed by the Bush administration as soon as possible.
For starters, while RU-486 is distributed in the United States by a company called Danco Laboratories, it is made by a state-owned pharmaceutical factory in China.
According to Rep. Tom Bliley, former chairman of the House Commerce Committee, this same factory has shipped highly contaminated, as well as mislabeled, drugs to the United States. It also has given false information to U.S. inspectors about plant conditions and procedures.
According to documents amassed by Bliley's office, one FDA official wrote, “The information in the (controls) that I reviewed didn't correspond to methods and specifications used by the firm.”
In fact, authorities at the plant had “copied” production standards from
U.S. manuals that had “nothing to do with the testing they perform.”
Next, the second drug required in the RU-486 regimen (Cytotec) has not been approved by the FDA for abortion. Its manufacturer, the Searle unit of Pharmacia Corp., has warned against this use.
Searle explained that the adverse events reported with off-label use of Cytotec in pregnant women include “maternal or fetal death” and “uterine hyperstimulation and rupture.”
Some claim these risks exist only in later pregnancy, but the Searle letter contains no such qualification. According to a former FDA general counsel, the agency's approval and encouragement of a drug's off-label use, to say nothing of going against the wishes of its manufacturer,
“sets an extraordinary precedent.”
Finally, the FDA approved RU-486 pursuant to regulations titled “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses.”
How an abortion drug was placed in this category remains a serious question. Accelerated approval can compromise the health interests of consumers, since these regulations allow for less testing of drugs before they are put on the market. But even more important is the effect on the legal rights of the drug's users.
Legal scholar Vivian Orlando explains that manufacturers of drugs approved under these regulations may escape liability for injuries associated with its use. But nowhere in the pages of warning and labeling for RU-486 will a woman be told of this.
Even absent the dangers that are specific to American FDA approval, RU-486 presents a health risk. The long-term effects are virtually unknown, and the method has proved dangerous in France, the country that produced and first allowed it. France's Health Ministry placed restrictions on its use in 1991 after the death of a 31-year-old woman and three reported cases of life-threatening heart attacks.
Logic alone explains why the drug has proved unpopular. RU-486's administration prolongs the unpleasant abortion experience, requiring three clinic visits over a span of two weeks, with considerable psychological and physical pain. And in 5 percent to 8 percent of cases, surgical abortion is still necessary to remove human remains or to stop excessive bleeding.
But the fundamental reason RU-486 is a danger applies to all abortion, chemical or otherwise. As one abortion practitioner testified, abortion is a “killing act.” It destroys the child conceived but not yet born, and in so doing also destroys a part of the mother. And when mothers and children suffer, so do we all.
(This article courtesy of Pro-Life Infonet. To subscribe, send the message “subscribe” to: infonet-request@prolifeinfo.org.)
