April 30, 2023
It was a confusing couple of weeks for providers and patients as the availability of mifepristone and medication abortions was put in the hands of the court system. One court ruled to rescind the FDA’s original approval of the drug, a second court with equal authority told the FDA not to change a thing, and an appeals court weighed in with a decision that preserved the approval of the drug but reverted to older, stricter rules for access.
The Supreme Court put an end to the chaos with a temporary stay that will last until the case has worked its way through the appeals process. While we wait for the final decision (which could be over a year away), we want to provide important background.
Mifepristone is one of two pills used in medication abortions. It stops an established pregnancy from progressing by blocking the hormone progesterone. It is followed 24 to 48 hours later by another drug called misoprostol which causes uterine contractions, cramping, and bleeding similar to what would happen in a miscarriage. Today, roughly half of abortions in this country are done with medication as the reduction in abortion providers even in states where the procedure is less restricted has made it more difficult to access surgical abortion.
Research shows that medication abortion successfully terminates pregnancy 99.6% of the time, and carries very little risk of major complications (less than .5%). The mortality rate associated with medication abortion is .64 per 100,000 uses. This makes it far safer than pregnancy/birth. It also makes it safer than other medications on the market including Viagra and its generics and Tylenol/acetaminophen.
A Timeline of FDA Rules for Mifepristone
Two Court Cases
An anti-abortion group calling themselves Alliance for Hippocratic Medicine brought a case against the FDA arguing that the process used to approve the medication abortion regimen, and mifepristone in particular, was unlawful. Remember, this approval took place over 20 years ago. Still, they asked as judge for an injunction that would essentially revoke the FDA’s approval of the medication and make it unavailable. The FDA argued that its approval of the mifepristone was medically justified and that allowing the court to overturn scientific decisions would throw the whole process for approving drugs in this country into chaos.
Judge Matthew Kacsmaryk, who is known to be anti-abortion, agreed with the plaintiffs. In his opinion he used anti-abortion rhetoric saying medication abortion was, “a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb.” He also downplayed the decades of research that say mifepristone is safe, and argued that the FDA was under political pressure by the Clinton administration to approve the drug. He essentially granted the temporary injunction but put a stay on his own decision to give the Biden administration time to appeal.
At the same time, a judge in Washington state heard a separate case challenging the FDA’s rules on mifepristone. This case was brought by the Attorneys General of 17 states and the District of Columbia where abortion remains legal with few restrictions. The AGs argued that the FDA rules were still too restrictive and asked the judge to remove the REMS so that mifepristone could become easier to access. Judge Thomas O. Rice did not agree to that, but did order that the FDA do nothing to change the status quo of mifepristone availability while this case works its way through the courts.
These competing decisions essentially forced the higher courts to take up the case on appeal which is likely the reason the AGs filed their suit in the first place.
The Appeals Court Decision
The Biden administration appealed Judge Kacsmaryk’s decision overturning the original FDA approval of mifepristone to the Fifth Circuit Court of Appeals which had jurisdiction. Neither the AGs nor the Biden administration appealed Judge Rice’s opinion because both parties would have been satisfied with that “change nothing” outcome.
The Fifth Circuit is known to be conservative especially on issues of abortion and its decision showed this. It did not uphold Kacsmaryk’s decision in its entirety because it ruled that too much time had gone by to challenge the original FDA approval of mifepristone. It did, however, say that the rule changes in 2016 and 2021 could be challenged and agreed with the plaintiffs that the Comstock Act (from the 1873!) prevents mifepristone from being sent through the mail. The court said that these portions of the FDA rules would be overturned while the case was heard on its measures.
This meant that for a day or two—before the Supreme Court stepped in—mifepristone was only available up to 7 week of pregnancy and could not be delivered by mail order.
The Supreme Court Steps In
The Biden administration filed an emergency application to the U.S. Supreme Court asking for a pause to the appeals court ruling that limited the availability of the mifepristone. Danco, the manufacturer of Mifeprix, the brand name of mifepristone, also asked the court for emergency relief to be able to continue to sell the product under existing rules.
On Friday April 24th, the Supreme Court issued a stay on the Fifth Circuit’s decision which means it cannot go into effect. The stay sends the case back to the Fifth Circuit to hear the government’s full appeal. While the court did not weigh in on the details of the case, it did say that stay will remain in place through the appeals court’s decision until such time as the Supreme Court hears/rules on the case or officially refuses to hear the case.
This means that no matter what the Fifth Circuit decides (and the odds are that it will rule against mifepristone) nothing will change instantly. Court cases can take a long time to get to SCOTUS. So, for the foreseeable future Mifepristone is available through 10 weeks of pregnancy, at some brick-and-mortar pharmacies, and by mail.
This was an important move by the court because all of this legal maneuvering was started by abortion opponents to make it harder to get a medication abortion even in states with few restrictions, and it clearly worked. The chaos and confusion of the last two weeks did just that.
As for what the Supreme Court will ultimately decide if/when it hears the full case, that’s hard to tell. The decision granting the stay was only one paragraph long and provided little insight into the thinking of the court. Seven justices voted for the stay, while Justices Alito and Thomas dissented.
As we know from the Dobbs decision, the majority of the justices are opposed to abortion rights, but this case may be different for a few reasons. First, the Dobbs decision said that abortion restrictions should be left up to the states to decide and the Fifth Circuit’s initial decision instead imposes nationwide rules for prescribing mifepristone even for states that want to make it easier to get medication abortions.
The court could also ignore the abortion issue entirely and deliver a ruling based on process and procedure because this decision would set a precedent allowing judges to interfere with the FDA. Not surprisingly, pharmaceutical companies weighed in with 250 executives signing a letter that said this would be terrible for the drug approval process broadly.
The good news is that access to mifepristone is secure while we wait and see.