Abortion Pill

The Oklahoma Supreme Court today overturned an Oklahoma law intended to ensure the safe use of abortion-inducing drugs, such as RU-486.  The law, enacted in 2011 and based upon an AUL model, simply required that abortion providers administer the drugs in the manner approved by the FDA.

The state’s interest in enacting such a law was clear: Since RU-486 was approved in 2000, thousands of women have faced complications, many life-threatening.  Both the FDA and the drug manufacturer have acknowledged the substantial risk of complications following use.  Fourteen women have died.  Eight of those women died of a severe bacterial infection that would not otherwise harm healthy women.  All eight of those women were instructed to use the drugs in a manner that directly contravened the approved FDA protocol. 

On the other hand, no women have died from bacterial infection after using RU-486 in the manner approved by the FDA.

With that in mind, Oklahoma adopted a law aimed at ensuring that RU-486 and other abortion-inducing drugs are administered only in the way approved by the FDA.  Rather than allowing providers to hand out dangerous drugs and send women home to self-administer away from physician oversight and beyond the gestational limit approved by the FDA, the law required that physicians examine women before administering the drugs and instructed that the drugs be administered in a clinical setting within the gestational limit approved by the FDA.

Of course, the law was immediately challenged by abortion providers (backed by the Center for Reproductive Rights), whose main interest is not protecting women’s health but making a profit.  After all, sending women home with the drugs and providing them past the gestational limit allows abortion providers to sell more of the dangerous drugs each day. 

During the course of litigation, the state of Oklahoma offered substantial evidence, demonstrating to the trial court (and then the state supreme court) that the misuse of abortion drugs is dangerous:

• The state established that the FDA approved the RU-486 drug regimen under a special code section (known as “Subpart H”) which allows the FDA to restrict the use of the drugs.  The FDA had serious concerns about the safety of RU-486, and wanted to ensure the safest use possible.
• The state established that thousands of women have faced complications following use of RU-486, including the 14 deaths. 
• The state established that eight women have died from bacterial infections following the improper use of RU-486, and that no women have died from bacterial infection following FDA-approved use of the drug regimen.
• The state established that FDA documents cite the incorrect use of RU-486 as “unapproved.” 
• The state established that surgical abortion is safer than drug-induced abortion.
• The state established that the law imposes no “undue burden” on women, because it is a commonsense regulation protecting women from harm.  The law does not ban abortion; it simply regulates the use of a drug proven to have dangerous—and deadly—consequences.
• And at the very least, the state established that the evidence provided by the plaintiff-abortion providers merely indicated that medical sources might differ on the dangers inherent in misuse of RU-486, and that in such a circumstance the Supreme Court has, under Gonzales v. Carhart, given state and federal legislatures “wide discretion” to regulate abortion for the safety of women.

AUL highlighted this information its brief filed before the Oklahoma Supreme Court, available here, on behalf of almost 40 percent of the state legislature.

But the state supreme court ignored it all.  Not once does the court mention the fact that women have died following use of RU-486.  Not once does the court cite FDA documents or scientific studies. 

Instead, the court misinterprets Planned Parenthood v. Casey and ignores the fact that the U.S. Supreme Court has clearly determined that states have an interest in the outset of pregnancy in protecting maternal health, and that regulations aimed at such impose no constitutional violations.

This decision leaves women seeking abortion-inducing drugs in a dangerous position, left to the whims of an abortion industry that misuses abortion drugs for profit.

The Sixth Circuit Court of Appeals today 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.

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.

Today AUL and 57 Oklahoma state legislators filed an amicus brief before the Oklahoma Supreme Court supporting the state’s regulation of abortion-inducing drugs. 

In 2011, the Oklahoma legislature enacted a measure regulating the provision of abortion-inducing drugs. The language is based on AUL’s “Abortion-Inducing Drugs Safety Act,” which requires that abortion providers administer the dangerous abortion drugs only in the way approved by the FDA.  At least 8 women are known to have died following use of the drugs in an off-label, unapproved manner.

An abortion provider and abortion advocacy group immediately challenged the law in an Oklahoma state court. AUL provided in-depth assistance to the office of the Oklahoma Solicitor General as he defended the case in the state trial court. However, for the first time in the state’s history, the judge created a “right” to abortion under the state constitution, and struck the regulations.

The State appealed to the Oklahoma Supreme Court, which took the case and asked for the parties to fully brief the issues.  AUL filed an amicus curiae brief advocating its own interests along with the interests of Oklahoma legislators, including the sponsors of the original bill (Senator Greg Treat and Representative Randy Grau), in protecting women from the dangers of off-label use of abortion-inducing drugs. Specifically, the brief details the evidence supporting the regulations that was ignored by the trial court, as well as demonstrates that the regulations do not in any way impose an undue burden on women seeking abortions.

The brief is available here.

The Sixth Circuit Court of Appeals has rejected Planned Parenthood’s challenge to a 2004 Ohio law regulating the abortion drug RU-486.  In Planned Parenthood Southwest Ohio v. DeWine, the court ruled that the Ohio law is not vague and does not impose an “undue burden” on women seeking abortions.  Rather than “using as directed,” the abortion industry has been handing out life-ending drugs against the restrictions established by the U.S. Food and Drug Administration (FDA), and some women died.  And yet, the abortion industry went to court to continue with its 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 drug 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.  In 2004, the legislature passed the measure which requires that physicians provide the Mifeprex regimen only in the way approved by the FDA.  In response, Planned Parenthood immediately filed suit.

Among Planned Parenthood’s claims were that the Ohio law is “vague” (i.e., Planned Parenthood allegedly didn’t understand what it was supposed to do, in being instructed to follow the FDA’s clear instructions for the administration of the drug regimen) and that the Ohio law creates an “undue burden.”  The Circuit rejected both of these claims.

The court also pointed out that “Planned Parenthood did not sustain its burden” in showing that the law imposes any burden on a woman seeking an abortion with the Mifeprex regimen.  “Review of the evidence shows that the district court correctly concluded that the record simply does not give rise to a reasonable inference that the [law] imposes a substantial obstacle for Ohio women deciding whether to abort a pregnancy.” 

Simply put, Planned Parenthood had been unable to produce any evidence that the regulation of the Mifeprex regimen creates any obstacle to women.  As is Planned Parenthood’s typical game plan, the abortion giant placed politically and financially motivated rhetoric before the court without any substance to back up its claims.  Both the lower court and the Sixth Circuit saw through this ruse.

The Circuit also noted that “the Supreme Court has not articulated any rule that would suggest that the right to choose abortion encompasses the right to choose a particular abortion method.” 

In sum, medically supported regulation of the Mifeprex regimen that is aimed at protecting women is not an “undue burden.”  It does not ban abortion.  Other alternatives—such as surgical abortion, which Planned Parenthood deems “very safe”—exist.  Requiring that abortion providers abide by the only regimen considered safe by the FDA is not an obstacle for women—it is a protection. 

AUL has been involved in this case since 2007, filing three amicus briefs on behalf of Members of Congress in support of the State of Ohio.  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.”  One issue still remains unresolved before the trial court, and therefore the case will continue.