U.S. Supreme Court Justice Samuel Alito on Friday temporarily blocked lower court rulings that imposed restrictions on the abortion pill mifepristone.
It follows a series of rapid-fire judicial rulings related to mifepristone issued within the past week are creating confusion for clinicians and patients alike. NCMS staff are still reviewing these decisions, but here are a few questions answered about these rulings and current access to mifepristone.
How many rulings have been issued?
As of April 14, there are three rulings to note:
- On April 7, a federal district judge from the Northern District of Texas suspended both the FDA’s original approval of mifepristone and several more recent policies that expanded access to the medication.
- Also on April 7, a federal court in Washington state issued a preliminary injunction blocking the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available” in a competing order. Although this ruling only applies to 17 states involved in the underlying lawsuit, its conflict with the Texas decision adds a layer of complication since the FDA is unable to simultaneously comply with both orders.
- On April 13, the 5th Circuit Court of Appeals temporarily blocked portions of the Texas ruling, but it permitted other aspects of the decision to move forward. The Court stayed the suspension of mifepristone’s FDA approval, allowing the medication to remain on the market, but with new restrictions such as prohibiting its use beyond seven weeks of pregnancy, barring its distribution by mail, and prohibiting physicians from prescribing the pill via telemedicine.
- On April 14, Supreme Court Justice Samuel Alito granted a brief administrative stay blocking the 5th Circuit’s decision until Wednesday, April 19.
Does this impact North Carolina?
Yes. Since these decisions impact FDA approval of mifepristone, they are applicable nationwide.
Is mifepristone currently banned in North Carolina?
No. Mifepristone is currently accessible in North Carolina subject to state requirements. North Carolina law extends beyond the FDA’s regulations, so many of the policy changes suspended by the Texas decision were never implemented in NC.
As previously noted in NCMS Morning Rounds, an unrelated lawsuit was filed by a North Carolina physician, Dr. Amy Bryant, to block the state’s restrictions. It remains to be seen whether these recent decisions will impact that case.
If the ruling is permitted to go into effect, mifepristone will only be available up to seven weeks of pregnancy and will require three in-person office visits under the supervision of a qualified physician. Although the medication remains available, it will be important to follow these decisions as they make their way through the appellate process. NCMS staff will keep you updated.
Are these decisions final?
No. The Justice Department disagrees with the 5th Circuit’s ruling and will ask the Supreme Court for an emergency stay of the 5th Circuit’s ruling. Dranco, a drug manufacturer, also filed an emergency request on April 14 seeking a stay.
In addition to the temporary stay granted by Justice Alito, the Supreme Court is expected to take more action on this issue soon. If the Supreme Court does not intervene on an emergency basis, the changes modifying access to the drug could go into effect at the end of this week.
What’s next?
Even if the Supreme Court declines to urgently intervene, the Court will likely issue its own ruling on the matter at a later date. The Supreme Court will also be called upon to help reconcile the conflicting Washington and Texas rulings.
This is outrageous! It is horrifying that a judge can undo a drug approval from 25 years ago—where will that precedent take us??
And access to mifepristone is for more than just elective termination—as all of us know! We have to fight HARD against this intrusion into our patients freedom and right to make their own healthcare decisions.