FDA Restrictions on RU 486 Not Strong Enough

Source: Conservative News Service June 14, 2000

Washington—Restrictions by the Food and Drug Administration in the distribution of the dangerous French abortion drug RU 486, which abortion rights groups have denounced as too restrictive, do not go far enough, pro-life groups say. Because of the drug’s dangerous risks and side effects, the FDA now is requiring a national registry of all the people prescribing RU 486. Those who prescribe RU-486 also must have admitting privileges at a hospital within one hour of their location.

Since the administration of RU 486 is a complicated procedure that is usually carried out over a three-day period, the drug’s prescription and administration should be restricted to those who are trained to perform surgical abortions, the FDA is suggesting. Randall K O’Bannon, Ph.D, Director of Education for the National Right to Life Committee, strongly opposes the introduction of the drug into the United States, saying, “If the FDA had been faithful to its basic mission of guarding public health, it should have protected the unborn child and rejected RU-486 altogether.”

The FDA’s concern about the health of women taking RU-486 is not new, nor is it unjustified, O’Bannon said. “This is a dangerous drug.” Not only does it destroy the life of an unborn child, it’s also going to harm the women who take it, he said. RU-486 currently is available to women in countries that boast variations of nationalized health care systems, such as France and Great Britain, and its distribution is done at limited locations under highly regulated conditions.

French people who administer RU-486 are required to have emergency resuscitative equipment and electro-cardiograph equipment nearby in case of complications, O’Bannon said. After the drug was first considered in the United States, even those who favored its use were aghast when they heard about the training program its sponsor was proposing. “They had a lot of these concerns way back in the beginning about how this was going to work. Not only about training on how to administer the pill, but training to do back-up surgery if the drug failed or if they had complications,” O’Bannon said. The first stage of the RU 486 abortion procedure calls for the administration of misepristone, a drug that kills the child in the womb.

This drug procedure is followed by another, the administration of misoprostol, which causes the dead unborn baby to be expelled from the womb. One of the problems associated with misoprostol is that some of the women who take it experience excessive bleeding. Over a 12-month period beginning in September 1994, the drug’s sponsors conducted a study in the US with 2,121 women ages 18 to 35 who were pregnant for periods of 63 days or less. Researchers found the primary negative side effect of RU-486 was excessive bleeding, some of which necessitated blood transfusions and resulted in hospitalizations, including emergency room visits, surgical interventions and administrations of intravenous fluid.

According to the FDA recommendation, doctors also should do follow-up studies of all the people who were prescribed RU 486. Researchers in the US found that some women bled for up to 60 days after they took RU 486 and some developed endometritis, an inflammation of the lining of the uterus, after taking the drug. Since there is an 8 percent failure rate of RU-486 to kill babies aged 49 days or less, the FDA ruled that those who administer the drug must be trained in providing surgical abortions. The farther along the woman is in her pregnancy, the greater the chances are that the drug will fail to kill the baby and will cause great harm to the mother. Although pro-life groups like National Right to Life would favor strong restrictions on the dangerous drug were it approved, they do not favor its approval. “We would not like it approved for this use, period, on the grounds that this is the life of an unborn child,” said Laura Echevarria, spokeswoman for National Right to Life. “But there’s such great potential danger to women’s lives as well, for the FDA to do anything less than these restrictions wouldn’t be wise. It should give women some pause. If the FDA is saying, OK, but … American women have to rethink: Is this the safe abortion drug as it’s been touted?”

Meanwhile, The Population Council, the pro-abortion organization that holds the US patent for RU-486, may be willing to accept government restrictions in order to win marketing approval, a representative of the organization told reporters at a briefing Tuesday. The Population Council and its marketing partner New York-based Danco Laboratories “would like to get the drug approved, and if we have to accept some restrictions we would do so, and try to get some of them repealed after approval,” Sandra Arnold, the organization’s VP for Corporate Affairs, told reporters.