FDA Approves RU-486 Abortion Drug

The United States Food & Drug Administration (FDA) approved the abortion pill, RU-486, for distribution in this country. The decision was announced on 28 Sep 2000. It should be available on the street in about a month.

RU-486 is a drug that causes very early abortions. The FDA approved it for use within the first seven weeks of pregnancy.

A little history

RU-486 was invented in France by the Roussel-Uclaf company in 1988. (The "RU" in the name is the initials of the name of the company; the "486" simply means that it was the 486th product they invented.) Roussel-Uclaf planned to market the drug in the U.S., but opposition from pro-lifers led them to back down. Partly they were afraid of boycotts, and partly they were embarassed when connections were drawn between this drug and earlier products by the same company. The controlling interest in Roussel-Uclaf is owned by a German company, Hoescht AG. During World War II Hoescht was a division of IG Farben, the company that made the zyklon gas used to kill Jews in the concentration camps. Many French people were disturbed by the connection.

But then they were subjected to counter-pressures from pro-abortionists, so in 1994 they came up with a "compromise": they donated the U.S. rights to the drug to a pro-abortion advocacy organization, the Population Council. The Population Council is not a drug manufacturer and had no facilities to actually produce or market such a drug, so they created a new company to do this, called Danco Laboritories. FDA approval was delayed until Danco could meet federal manufacturing and labeling requirements.

RU-486 is now available in 14 countries.

The politics

An Associated Press report said that this decision "end[s] a battle hat has involved two presidents, several countries and heated debate for 12 years". But of course opponents of abortion do not concede that the battle is over. This decision was long expected. The only real surprise was that pro-lifers managed to delay it this long.

In an unusual -- perhaps unprecedented -- move, the FDA has kept secret the names of the officials who were involved in this decision in order to protect them from controversy. "The climate around the reproductive-rights issue and personal safety issues are in our minds," FDA Commissioner Jane Henney explained.

Similarly, Danco Laboritories, the company that will be marketing the drug, has refused to say where it will actually be produced. (Danco has no facilities to actually produce the drug themselves, and no U.S. drug company was willing to risk a boycott from pro-lifers and lawsuits for injuries from complications.) The Wall Street Journal reported (Sept 5) that Danco has contracted with a manufacturing plant in China to produce the drug.

How it works

RU-486, also known as "mifepristone" and "Mifeprex" (Danco's trade name), can only be used within the first few weeks of pregnancy. The FDA set a limit of 49 days.

To use this drug, the mother takes three mifepristone pills. This interferes with a hormone called progesterone. Without the action of this hormone the lining of the uterus cannot be maintained, which cuts off the supply of nutrients and oxygen to the developing baby, and sometimes causes him to detach from the uterine lining completely. Two days later, she returns to the doctor to take a second drug, misoprostol, that causes the uterus to contract and expel the dead or dying embryo. Two weeks later she returns for a third visit to make sure the abortion is "complete". If the unborn baby has survived -- as happens in 5 to 8 percent of cases -- then an alternative method of abortion can be performed.

Health concerns

A number of concerns were raised about dangers to the mother. The pill-induced abortion can be painful, causing bleeding and nausea. Heavy bleeding is a potentially serious side effect but one the FDA determined is rare. In safety testing of the first 2,100 American women who took RU-486, about 1 in a 100 had complications serious enough to require hospitalization, and four bled enough to need major transfusions.

However, these trials specifically excluded women who were considered high-risk, such as women under 18, those with hypertension or anemia, and heavy smokers over 35.

As noted above, the mifepristone must be used with a second drug, misoprostol, to be effective. Misoprostol was developed to treat ulcers, and the company that makes it has objected to its use as an abortion drug because of safety concerns.

A group of doctors and others submitted a petition to the FDA objecting to approval on health grounds. Dr Donna Harrison, an obstetrician and one of the signers, explained, "What we found was a 10 percent hemorrhage rate of which 1 to 2 percent was significant enough to require transfusion. We found a 5 to 15 percent rate of pelvic infection, with 25 percent of those women subsequently sterile."

Early drafts of the FDA approval imposed numerous restrictions on the use of this drug. But most of these restrictions were removed by the final draft. The FDA now requires that women considering RU-486 be given a brochure, called a "MedGuide", that explains the circumstances under which the drug is suitable, and discusses procedures and side effects. To dispense RU-486, an abortionist must certify that he is trained to diagnose factors that would make RU-486 exceptionally dangerous, for example, he must be capable of determining the duration of the pregnancy so women after the seven week limit can be excluded, and he must be able to recognize ectopic (tubal) pregnancies. He must also be able to perform a surgical abortion in cases where the drug fails, or have arrangements for some other abortionist to do this.

"Only four months ago, after years of study, the FDA recognized the substantial risks of this two-drug abortion method, proposing restrictions such as requiring administration within one hour [driving distance] of an emergency room," commented Randall K. O'Bannon, Ph.D., NRLC's Director of Education, who has written extensively on issues surrounding RU-486. "Now, four months later, the FDA has dropped most of these protections for women's health. What has changed, other than a four-month campaign of political pressure by the abortion industry and its allies? The FDA opted for the convenience of abortionists over the safety of women."

The impact

Abortion providers say the pill-caused abortion should cost the same as surgical abortion, but a Danco spokesman refused to confirm that.

The National Abortion Federation, a national affiliation of abortion facilities, said 240 of its member abortion businesses were already prepared to sell Mifeprex, and it is training other abortion practitioners in how to use the pill.

Proponents say that RU-486 will make abortion easier on the mother psychologically than surgical abortion, because it "feels more like a miscarriage", is done earlier in pregnancy, and, they hope, ultimately can be done in the privacy of a woman's own home.

Others worry that this will just make the abortion experience even worse. Women will be having abortions alone, with no one else around for emotional support. And if she later regrets the decision, she will feel the full burden of it herself, with no way to share the responsibility for the decision with others.

Supporters of RU-486 say that it will make abortion "more accessible and more private". They hold it out as a solution for women who live in areas with no convenient abortion clinic, or who are reluctant to pass through protestors to enter an abortion clinic. But when opponents say that it will make abortions even more common, they reply that "health experts" found that it did not increase the number of abortions when it was introduced in Europe. So ... will RU-486 make abortion more accessible for American women, or not?

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Posted 4 Oct 2000.