The RU-486 abortion pill:

Regulation and production difficulties

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Regulation Difficulties:

In late 1988, Roussel-Uclaf started distribution of the drug in France. But they withdrew it after some of its personnel had received death threats. The French government forced the company to return RU-486 to the market. Claude Evin, the French health minister called "RU-486 the moral property of women, not just the property of the drug company."

Pro-life pressure on the U.S. Food and Drug Administration caused them to ban the importation of RU-486 into the United States until 1993. Boycotts were organized against Roussel-Uclaf, its parent company, and its American affiliates.

A non-profit, New York-based group, Population Council obtained patent rights to the pill in 1994-MAY. A clinical trial was conducted during 1994-5. Following a Food and Drug Administration hearing in 1996, the FDA Advisory Committee recommended that the FDA approved mifepristone in combination with misoprostol as a safe and effective way to end pregnancies of up to 7 weeks gestation. The FDA issued an statement in 1996-SEP, stating that mifespristone is safe and effective. However, it asked that the Population Council and its licensee provide additional information.

Under pressure from anti-abortion groups, Hoechst AF of Germany halted distribution everywhere except in England, France and Sweden. In 1997, they stopped production entirely, and gave their rights to a new French company, Exelgyn.

In 1998, Abortion Rights Mobilization manufactured and distributed small test quantities of the drug in the U.S. A spokesperson said "We keep our place secret because of the danger that someone will throw a bomb through the window...It's sad, but that's the way it is."

In 1997-APR, the Canadian rights to distribute the pill were assigned to Exelgyn. The Canadian government does not approve drugs unless they permission is first sought from Health Canada by the manufacturer. This has not happened. However, with the increase in violence against abortion clinics and abortion providers, the provincial government of British Columbia has been pressuring the federal government to approve RU-486 for use in Canada. The federal government responded in early 1998 by sending a letter to Exelgyn, indicating that the political climate in Canada was such that their pill would get a fair hearing. ₁

On 1998-JUN-24, the U.S. House passed a bill to bar approval of RU-486 by the Food and Drug Administration. The vote was 223 to 202.  Tom Coburn (R-OK) said that if the pill were approved, it would be "killing babies". Also, he said that it would violate the FDA's directive of approving drugs that are "safe and effective." The bill was never signed into law.

The medication became generally available in the U.S. by 2000-DEC. It is distributed by Danco Laboratories under the name "Mifeprex."

RU-486 clinical trials were started in Canada. However, they were stopped when a woman died. A subsequent investigation showed that her death was not caused by the "abortion pill."

Production of RU-486:

European and North American pharmaceutical companies have been reluctant to manufacture or distribute RU-486, for four reasons:

Lawrence Lader, director of Abortion Rights Mobilization, commented: "Every major drug company turned it down. Big-name people won't touch it." 

Danco Laboratories, the U.S. distributor, was finally able to locate one pharmaecutical company which was willing to manufacture Mifeprex: the Shanghai Hua Lian Pharmaceutical Company in China.

Court challenge to an Ohio law:

The Food and Drug Administration (FDA) recommends a 600 mg dose of RU-486, and a maximum time limit of 7 weeks gestation. However, some physicians prescribe drugs "off label." This means that they deviate from FDA recommendations and follow "...the best and most recent advice available. Even the FDA acknowledges that dosages and drug regimens evolve as pharmaceutical products become widely used." ₃ Aspirin is a well-known example. The FDA recommends ASA for the relief of headaches. But many physicians suggest that their patients take 81 mg ASA tablets to thin the viscosity of their blood and perhaps reduce their risk of a heart attack. Another example is tetracycline which is approved for pneumonia and respiratory infections. Some doctors prescribe it to control acne. Medical literature shows that RU-486 can be safely used up to the ninth week -- and perhaps later -- and is effective at much lower dosage.

In 2004, the Ohio Legislature, under pressure from pro-life groups, passed a law which states that any doctor who exceeds the FDA time limit or deviates from the recommended dose is committing a criminal act and can be sentenced to jail for up to 18 months. The time-limit/strength legislation is unique in the U.S. RU-486 is the only drug limited by the State of Ohio in this way.

State Assistant Attorney General Anne Berry Strait defends the legislation. In her court brief, she noted that the FDA limit was set as a result of data obtained during large French and American clinical trials . She wrote that: "Those same trials, found that the efficacy greatly decreased, and side effects and adverse events greatly increased, at gestational ages above 49 days." ₃

The FDA and the Centers for Disease Control and Prevention are planning to study the deaths of four women in California who had taken RU-486. They, as well as a Canadian woman who died in 2001 were killed by a bacteria Clostridium sordellii, "...which seldom sickens people. Researchers are puzzled because the bacteria are frequently present in the human body without causing harm." In the case of the California deaths, "off-label" dosing was involved. According to Susan Cruzan, an FDA spokesperson, the deaths are puzzling and will be examined during a meeting in 2006. She pointed out that there is noclear-cut evidence linking the pill to the infections.

The 6th Circuit Court of Appeals is scheduled to hear arguments in a lawsuit initiated by Planned Parenthood (PP) and the American Civil Liberties Union (ACLU) which has challenged the constitutionality of the Ohio law. The American College of Obstetricians and Gynecologists -- a 46,000 member professional association -- joined with PP and ACLU at the last minute.

State Representative Tom Brinkman, (R-Cincinnati) said that the Ohio legislation was intended to reduce the wide access to abortion given to women by the U.S. Supreme Court in their 1973 Roe v. Wade decision. He said:

"The fact is that Planned Parenthood and the women's clinics wanted those pills to be passed out like candy. We're not saying go down to the right-wing religious nut doctor down the street; we're saying go to the abortion doctor and follow the FDA rules." ₃

References:

The following information sources were used to prepare and update the above essay. The hyperlinks are not necessarily still active today.

1. Anne McIlroy, "Canada approaches abortion-pill maker," The Globe and Mail, 1999-MAR-12, P. A10.
2. "Pros and cons of abortion pill," Toronto Daily Star, 1999-JUL-19.
3. Bill Sloat, "Doctors join foes of Ohio's pill limits. Ohio challenged on use limitations," Plain Dealer, Cleveland, OH, 2005-DEC-05.

Copyright © 1997 to 2008 by Ontario Consultants on Religious Tolerance
Latest update: 2008-APR-25
Author: B.A. Robinson