The issue of abortion is again before the Supreme Court, with certiorari granted to review a decision by the Oklahoma Supreme Court which struck down a statute barring the off-label use of abortion-inducing drugs. We took the time to learn the prerequisite medical vocabulary, then reviewed an amicus brief in favor of the law.
Today, we'll look at the arguments against the statute, as made in the opposition to the petition for certiorari, including the issue that is presently confounding the Supreme Court. When cert was granted, the court certified two questions to the Oklahoma Supreme Court: whether the statute inadvertently prohibits the use of misoprostol for all purposes, including for the FDA-approved on-label two drug abortion regimen, and whether the language inadvertently bars the use of methotrexate to treat ectopic pregnancies.
Off-Label is Prevalent, Superior, Safe
On the surface, it may seem to make sense to ban an off-label treatment. After all, on-label treatments have been reviewed and approved by the FDA, and therefore, should be safe.
After FDA approval, however, comes the real world and the lessons of experience. An expert cited by Slate estimates that as much as half of medical treatments are "off-label." This is because as treatments are used in practice, more efficient usages are often discovered.
In regards to the off-label uses of RU-486, a.k.a. mifepristone, the statute's opponents argue that the alternative regimens employed use smaller dosages, have a longer effective period (two weeks beyond the label, and the statute's 49-day limitation), and allow the woman to administer the drug in the privacy of her own home.
They also note that the "American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization have formally recommended these evidence-based regimens over the [on label] protocol," and that at least 96 percent of medical abortions performed nationwide involve an "evidence-based" regimen that differs from the FDA-approved label.
Okla.'s Reading of Statute is "Atextual"
In regards to the Supreme Court's first question, the statute's opponents argue that the state did, indeed, inadvertently ban misoprostol completely. It bans "off-label" use "with the intent of terminating" a clinically diagnosed pregnancy. Misoprostol is not, by itself, approved for use as an abortion-inducing drug. Its use with methotrexate then, for medical abortions, is off-label, according to the statute's opponents.
The confusion comes from how one defines off-label. While the FDA has an approved on-label regimen for misoprostol and methotrexate together as an abortifacient, individually, their labels are for other medical conditions. Both drugs, therefore, are both on-label and off-label at the same time when used for abortions, depending on who is making the argument.
As for ectopic pregnancies, the statute bans the off-label use of "any abortion-inducing drug," which includes methotrexate, for the purposes of terminating pregnancies. Methotrexate is the only non-surgical treatment for ectopic pregnancies, and of course, it is off-label. The statute, on its face, precludes such use, and requires women to utilize the riskier surgical alternatives.
(The statute's proponents, recall, cite definitions of pregnancy that begin when the pre-embryo implants in the uterus. Technically, per those definitions, an ectopic, or tubal, pregnancy isn't a pregnancy at all.)
Which side has the better argument? That's for the courts to decide, and as soon as the Oklahoma Supreme Court answers the certified questions, we'll tally up the score and sort through the remaining issues.