Attorney General Tom Horne wants to take a legal battle against Planned Parenthood of Arizona all the way to the United States Supreme Court. The two are fighting over a law passed by the Arizona Legislature in 2012 that would force physicians to follow the original FDA approval guidelines for a medication used in non-surgical abortions.
The debate stems over shifts in how Mifepristone--also known as RU486--has been used since its initial approval by the Food and Drug Administration. Mifepristone is the first of two drugs used in medication-induced abortions; it essentially encourages the body to stop nourishing a pregnancy. When the FDA approved it in 2000, women were given nearly three times the dosage they are today, says Bryan Howard, President and CEO of Planned Parenthood of Arizona. Mifepristone could only be used during the first seven weeks of pregnancy, and women were mandated to return to their doctors for an additional visit in which they would be administered a second medication used to induce contractions.
But in the 14 years since Mifepristone's original FDA approval, hundreds of thousands of women have had medication-induced abortions, and knowledge of the medication has expanded far beyond what was known back in 2000. "Uses of medication evolve after the point at which the FDA approves them," Howard says. "That's not just standard, but the expectation."
Over time, doctors discovered that a lower dosage of Mifepristone was just as effective, that it could be used through the first nine weeks of pregnancy, and that it was not medically necessary for women to complete the second portion of the procedure at a doctor's office (women can now take the second pill at home). Such shifts in the use of a medication are known as evidence-based medicine, a practice that the FDA does not generally restrict.
The discovery of broader uses of Mifepristone came about quickly. Here in Arizona, medication-induced abortion was offered by Planned Parenthood beginning about six months after the FDA first approved the medication. Best practices in the use of Mifepristone already had evolved by that point, Howard says. "When we started, the lower dosage already had been identified as preferable. The lower dosage's efficacy became apparent very quickly," Howard says.
These changes--using Mifepristone through the ninth week, in smaller doses, and without a mandatory second visit to the doctor--have been in place for almost a decade, Howard says. In that time, Planned Parenthood, which provides about one-third of abortion services nationally, has offered medication-induced abortion to about 130,000 women. And Howard says the tweaks in Mifepristone's administration are not used just at Planned Parenthood but within the OB-GYN community as a whole.
But in 2012, the Legislature approved a bill that would set back the clock, only allowing physicians to use Mifepristone according to the guidelines under which the FDA originally approved it. "They required that providers go back to 2000 standard and not be allowed to recognize the medical learning that had taken place since then," Howard says.
Howard thinks the legislature's reasoning was simple. "We would contend that the legislature, or the proponents within who proposed this, wanted to make the process of non-surgical abortion more burdensome," he says.
When the law passed, the State Department of Health Services was given up to two years to craft the specific guidelines for how the new regulations would be implemented. They published the new rules in February, with plans for them to take effect in April. The regulations closely mirrored the FDA approval guidelines, shrinking the window of time during which women could seek medication-induced abortion, forcing doctors to prescribe the original, higher dosage (one that was no longer deemed medically necessary and that would come at a higher cost) and dictating that women must make an additional trip to the doctor's office to receive the second medication.
In Arizona, that would mean four trips to the doctor for a medication-induced abortion: an initial counseling session 24 hours before the procedure, a second and third trip to receive Mifepristone and the second medication, and a fourth and final follow-up visit two weeks later. "Between the state-mandated counseling visit and the state-mandated return visit, you are going from two visits--which are medically indicated--to four visits," Howard says. "We know for poor women having to take time off work, women who already have children at home, or women from rural communities, this can be an insurmountable barrier."
So last March, before the regulations went into effect, Planned Parenthood of Arizona decided to fight the new law. Along with Dr. William Richardson, an OB-GYN in private practice, Planned Parenthood brought suit in Tucson Federal District Court, arguing that there was no evidence of any medical benefit to women in rolling back to the 2000 standards. Implementation of the new regulations was put on hold while the case was resolved.
The judge in Tucson ruled that while there was no demonstrable benefit to women in reverting to the new (old) standards, the Legislature still had the authority to pass such a law. So for 24 hours, on April Fool's Day of this year, the 2012 law finally went into effect.
Planned Parenthood of Arizona spent that day assessing how much it would have to charge for medicine-induced abortions under the throwback measures. The organization previously had charged the same for medicinal and surgical abortions, Howard says, in large part so that women did not have to consider cost in making a decision about which route to go. The law wasn't in place long enough for Planned Parenthood to finalize its cost differential, but Howard says they were likely going to have to charge women $200 more for a non-surgical abortion than for a surgical abortion under the new measures.
In the meantime, Planned Parenthood appealed the Tucson court's decision, and the case was brought before a three-judge panel at the 9th U.S. Circuit Court of Appeals in San Francisco. The panel immediately put the law back on hold.
In the appellate court proceedings, Planned Parenthood had some serious backers. The American Medical Association and American College of Obstetricians and Gynecologists filed a friend of the court brief on behalf of Planned Parenthood, writing "The Arizona law impedes physician discretion and contravenes medical ethics by outlawing the safest, most effective method of medical abortion and relegating women to an outdated, inferior treatment." They added, "There is no question that the Arizona law confers significant risk and no benefit to women's health. Put simply, the law is bad medicine."
In May, the appeals court agreed that the Arizona law provided no medical benefit to women, and said the Tucson judge had applied the wrong legal standard in assessing whether the Legislature's bill was constitutional. Suggesting that the case was not about whether the Legislature had the right to pass the bill but rather whether there was a rational health benefit to women in going back the original FDA approval standards for Mifepristone, the San Francisco court instructed Arizona Attorney General Tom Horne to take the case back to Tucson to have the law reassessed under the proper standard at a trial.
But Horne didn't want to. Instead of making the case in Tucson that there is a health benefit to the legislation, Horne announced that he would take the case all the way to the United States Supreme Court. On Monday, he received permission from the San Francisco court to do so.
Horne says he is simply doing his job as the state's attorney general: defending its laws in court. "Attorney General Horne is asking the Supreme Court to review the case because we believe this statute is constitutional," says Horne spokeswoman Krystal Gonzalez. She contends that Horne's fight isn't about abortion access, or politics. "Our position is a legal position in defense of a state statute," she says.
Planned Parenthood of Arizona doesn't agree, arguing that Horne's decision is closely tied to his re-election campaign. "We are contending that if he seriously believes that the Legislature had acted on the basis of women's health, then go to Tucson and make that case," says Howard.
But Horne's office has another solid argument for its decision to go all the way to the nation's highest court. So far, four other states have passed legislation requiring doctors to go by the FDA approval standards for Mifepristone. But there have been highly different outcomes in the resulting litigation in each of these states.
In Oklahoma, opponents of the Mifepristone regulations enacted there took a different approach than Planned Parenthood of Arizona. In a state-level trial over Oklahoma's legislation, opponents argued that a ban on straying from the FDA's original approval standards for Mifepristone would in fact outlaw medication-induced abortion altogether.
Why? Because the second drug used in the procedure, Misoprostol, actually has never been approved for use in abortions. Misoprostol is a decades-old drug used in cancer management and other medical treatments. It causes uterine contractions as a side effect. Opponents of the Oklahoma law argued that legislation requiring strict adherence to FDA approval guidelines would thus prevent the use of Misoprostol in abortions, effectively forcing all women seeking abortion to go the surgical route. In this light, the Oklahoma Supreme Court determined that its state's legislation was "so completely at odds with the standard that governs the practice of medicine that it can serve no purpose other than to prevent women from obtaining abortions and to punish and discriminate against those who do."
Oklahoma's law never took effect. Nor did similar legislation in North Dakota. But in Texas, women are now required to make four visits to a doctor for medication-induced abortions, and in Ohio, laws similar to Arizona's were upheld and have gone into effect.
Horne's office highlighted these drastic differences across the states when it sought permission to bring Arizona's case to D.C.
It will likely be months before the Supreme Court announces whether it will hear the Arizona case this session, if at all. Arizona's law will remain on hold meanwhile.
"Attorney General Horne is extending the legacy of extremist Arizona politicians who have repeatedly sought to impose restrictions on access to abortion and contraception, despite being forewarned that these measures violate women's rights to privacy and their ability to make their own healthcare decisions without interference," says Howard.
Horne's office disputes this analysis of their position. "It is founded on legal principles, as set forth in our briefing, without regard to political concerns," Gonzalez says.
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