The Sixth Circuit Court of Appeals, in late November, denied Planned Parenthood’s request that the court revisit its prior decision in Planned Parenthood Southwest Ohio v. DeWine, upholding Ohio’s regulation of RU-486. In October, the Sixth Circuit rejected Planned Parenthood’s challenge to a 2004 Ohio law which requires that abortion providers dispense RU-486 only in the manner approved by the Food and Drug Administration (FDA).
Rather than “using as directed,” the abortion industry has been handing out life-ending drugs using unapproved protocols that violate the restrictions established by the FDA, and some women have died. And yet, the abortion industry went to court to fight for the right to continue with these potentially deadly practices.
The FDA approved the abortion drug regimen RU-486 (under the brand name “Mifeprex”) for use only through 49 days of pregnancy. The regimen actually involves two different drugs: oral administration of mifepristone on day one, followed by an oral administration of misoprostol on day 3 (together known as the “Mifeprex regimen”). The FDA approved the Mifeprex regimen under a special code section that allows the FDA to restrict the use of the drugs.
Not only did the FDA approve the drug just through 49 days gestation, but the FDA specifically outlined that women are to take each dose in a clinic or physician’s office, with the second dose in the regimen to be taken orally. However, abortion providers—including Planned Parenthood—purposely flout these restrictions, providing the drugs past 49 days and instructing women to take the second dose at home vaginally or buccally (not orally).
But providing the Mifeprex regimen outside the restrictions approved by the FDA is dangerous.
In 2011, the FDA reported that 14 women had died after using the Mifeprex regimen, and eight of these women had died from a bacterial infection. In all eight deaths, the Mifeprex regimen had been administered in a manner unapproved by the FDA. Significantly, no woman has died from bacterial infection following use of the Mifeprex regimen as approved by the FDA.
As reported by the U.S. Government Accountability Office (GAO), the number of women dying from bacterial infection following use of the Mifeprex regimen is not within the range expected. In other words, more women have died from bacterial infection following use of the Mifeprex regimen than the FDA expected—and in all eight cases, the drugs were used in an unapproved manner.
Notably, the labeling for the Mifeprex regimen states that nearly all women will suffer adverse effects following use of the drug regimen.
And hence the need for the Ohio law, which prevents abortion providers from dispensing the dangerous drugs in ways that are not approved by the FDA.
Today’s decision is significant for a number of reasons. First, it marks the second time Planned Parenthood has been defeated in its effort to continue misusing RU-486. Second, the Sixth Circuit was the first federal court of appeals to hear a case involving a regulation of RU-486, meaning the pro-life community has been given the first major win on this issue. Moreover, other courts currently considering similar regulations—like the Oklahoma Supreme Court—could be encouraged by this decision to uphold other state laws regulating abortion-inducing drugs.
This decision should also encourage more states to pass similar laws. For individuals and groups interested in regulating abortion-inducing drugs, AUL has drafted model legislation, the Abortion-Inducing Drugs Safety Act, which is available here.
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AUL has been involved in this case since 2007, filing three amicus briefs on behalf of Members of Congress and in support of the Ohio law. The most recent was filed on behalf of Speaker of the U.S. House of Representatives John Boehner (OH), U.S. Senator Tom Coburn, M.D. (OK), and U.S. Representatives Steve Austria (OH), Dan Benishek, M.D. (MI), Diane Black, R.N. (TN), Charles Boustany, M.D. (LA), Paul Broun, M.D. (GA), Bill Cassidy, M.D. (LA), Steve Chabot (OH), John Fleming, M.D. (LA), Bob Gibbs (OH), Andy Harris, M.D. (MD), Bill Johnson (OH), Jim Jordan (OH), Robert Latta (OH), Jean Schmidt (OH), Steve Stivers (OH), and Pat Tiberi (OH), demonstrating to the Sixth Circuit that medically appropriate regulation of the Mifeprex regimen is not an “undue burden” to women considering abortion. One issue in the case remains unresolved, therefore the litigation will continue.