On Tuesday, the Oklahoma Supreme Court handed down a ruling that will help determine how the U.S. Supreme Court handles its next big abortion case. But Cline v. Oklahoma Coalition for Reproductive Justice hasn’t been scheduled for oral arguments just yet. The law in question, which deals with abortion-inducing drugs, was messily written, leaving room for considerable doubt about whether the state of Oklahoma intended to require doctors to follow a particular set of dosage requirements (the state attorney’s argument)—or ban the use of the drugs for abortion entirely (the Oklahoma Coalition for Reproductive Justice’s argument). When it accepted the case, the U.S. Supreme Court sent it back to the Oklahoma court for clarification about the law’s original aim. After several months of deliberation, the Oklahoma justices decided that the law effectively bans all medication-induced abortions by prohibiting the use of one crucial drug. Now, the U.S. Supreme Court will have to decide whether to dismiss the case and defer to the Oklahoma Supreme Court’s original ruling, which declared the law unconstitutional, or proceed. If they go ahead with the case, the court will face a weighty question: Is it legal for a state to effectively prohibit a procedure that accounts for 25 percent of first-trimester abortions?
Medication abortions are available to women who are still in their first trimester and would rather have a drug-induced miscarriage than a surgical procedure to end the pregnancy. Most doctors, when prescribing the two medications that cause abortion—misoprostol and mifepristone, commonly packaged together under the brand name “Mifeprex”—follow evidence-based guidelines recommended by the American College of Obstetricians and Gynecologists and the World Health Organization that deviate slightly from the regimen that the FDA outlined when it approved Mifeprex in 2000. The biggest difference between the two treatments is timing: According to the FDA, medication abortion can only be provided through seven weeks of pregnancy, but doctors commonly prescribe it for women through nine weeks.
As part of the larger cascade of abortion restrictions that have swept the country in the past three years, five states, including Oklahoma, have passed laws requiring doctors who prescribe abortion drugs to follow the FDA protocol, but only the laws in Texas, Arizona, and Ohio are in effect. Oklahoma’s law has been suspended since 2011 pending the outcome of the case, and a judge in North Dakota struck down its law earlier this year. But the courts aren’t consistently opposed to laws that impose the FDA protocol on abortion providers. On Monday, a federal judge in Texas partially upheld such a law, saying that although off-label use is safe and effective, requiring the FDA protocol is not an “undue burden” for a woman seeking an abortion, except in situations where her life is in danger. Last year, a federal court in Ohio came to a similar conclusion.
The question, now, is whether the U.S. Supreme Court wants to tackle a case that goes beyond the other states’ fairly straightforward regulations on how abortion-inducing drugs should be prescribed. The complications stem mainly from the fact that misoprostol, although it’s included in the FDA’s regimen for Mifeprex, isn’t technically approved for abortion. According to its label, misoprostol is used to prevent gastric ulcers; in a medication abortion, it contracts the uterus and expels the embryo. But the Oklahoma Supreme Court’s decision added another wrinkle to the case. In addition to banning medication abortion, it ruled that the law prohibits doctors from using methotrexate, a drug approved by the FDA for as a remedy for psoriasis and rheumatoid arthritis, to treat ectopic pregnancy. The only alternative to treatment for ectopic pregnancy, a potentially fatal complication, is surgery. “The Oklahoma Supreme Court’s ruling threw the issues into sharper relief,” says Michelle Movahed, a senior staff attorney at the Center for Reproductive Rights and one of the lead attorneys on the case. “It makes it clear that this law is as extreme as it seemed. But we have to wait and see what the Supreme Court will do next.”
When they’re written correctly, laws like Oklahoma’s are clever. Their Machiavellian genius is that, on the surface, requiring doctors to follow the FDA protocol sounds like a great idea. If doctors are deviating from the government-sanctioned regimen for abortion-inducing drugs, one might reasonably ask, isn’t that a genuine women’s health concern—and shouldn’t the state have every reason to step in?
The problem is, that’s not how science works. When the FDA approves a drug, it uses the best research available at the time to suggest a regimen for the drug’s use—but doctors and scientists don’t stop studying its effects. As more studies come out, they often show that drugs have other medical functions, or can be used in a different way to more effectively provide care. Obtaining re-approval for a new use of the drug or a treatment regimen is laborious and expensive, and drug companies aren’t required to do it, so many don’t bother. As a result, doctors prescribe drugs “off label,” basing their recommendations not on the FDA’s standards, which can be outdated, but on the latest scientific evidence. The Mayo Clinic estimates that approximately 20 percent of commonly used drugs are prescribed off label.
“The FDA encourages it,” says Mitchell Creinin, a professor of obstetrics and gynecology at the University of California-Davis. “They say, look, we know that more literature will become available. Of course, you can’t just say, ‘I think aspirin will work for a runny nose.’ You need to use a validated regimen. And you have to inform the patient.”
It’s been more than a decade since the FDA approved Mifeprex, and since then, doctors have made a number of adjustments to the standard procedure for prescribing the drug. For women up to seven weeks pregnant, the FDA protocol prescribes 600 mg of Mifeprex, given over the course of three clinic visits. The mifepristone is taken on the first day, to block the hormone progesterone, which is needed to sustain the pregnancy. Two days later, the woman comes back to the clinic to take a dose of misoprostol that expels the embryo; she returns to the clinic once again within two weeks for a checkup. Later research showed that the dosage could be substantially reduced, the second clinic visit was unnecessary, and the medicine was safe for women up to nine weeks pregnant. Now, most doctors give 200 mg of Mifeprex over two clinic visits, allowing women to take the misoprostol at home.
The new regimen is cheaper—it costs $90 rather than $270—and it’s more effective. The World Health Organization recommends the evidence-based protocol for medication abortion; for many doctors, following the FDA’s guidelines would be agreeing to practice bad medicine. “No professional wants to use a regimen that’s less safe, more expensive, and has worse side effects,” says Tracy Weitz, a professor of obstetrics, gynecology, and reproductive sciences at the University of California-San Francisco. “You don’t give someone three pills if you know one pill is enough.”
If the Supreme Court chooses to take the Oklahoma case, their charge will be considerably broader than addressing the constitutionality of the FDA protocol laws. Rather than considering a particular limitation on abortion access, the case will hinge on whether it’s constitutional to prohibit a procedure that comprises one-quarter of first-trimester abortions. That’s not necessarily good news for pro-choice advocates. “I think it’s likely that the Supreme Court would rule that since surgical methods are available, a ban on medication abortion isn’t an undue burden,” says Jessie Hill, a professor of law at Case Western Reserve University who worked on Ohio’s FDA protocol case. “They’d say, you can’t complain if there’s another equally effective method out there.”
Of course, it’s equally likely that the Supreme Court will reject the case without moving further, allowing the Oklahoma ruling to stand. Hill points out that the Oklahoma Supreme Court’s expansive ruling may have produced a higher-stakes challenge than the high court’s justices were bargaining for. But if the case is dismissed, states looking to restrict abortion access won’t be deterred from passing similar legislation; they’ll just take more pains to ensure that the legislation is precise. To doctors, the FDA protocol requirements are just one more in a long line of attempts to limit abortion access in the name of women’s health—and infringe on their rights as medical practitioners. “The legislators who are behind these laws would hate it if we applied these same restrictions to any other kind of medicine,” Creinin says. “If they got cancer, and I said they could only use the FDA guidelines for their cancer drugs, they’d be outraged. These laws are not about women’s safety. They’re about trying to inhibit the safe provision of medical care.”