The fate of a commonly used abortion pill is now in the hands of the United States Court of Appeals for the Fifth Circuit, which is set to rule on the availability of a medicine used in more than half of abortions in the United States. Last month, the Supreme Court temporarily suspended attempts to severely restrict the availability of mifepristone while an appeal was heard.
It is the most recent development in a fierce battle over the legal validity of the medication mifepristone. Even in places where abortion is allowed, the decision might have far-reaching implications for the FDA’s regulatory jurisdiction over other pharmaceuticals.
Here’s what’s happening now.
What Took Place?
In April, Judge Matthew J Kacsmaryk of the Northern District Of Texas issued a preliminary judgment rejecting the FDA’s 23-year-old approval of mifepristone. A few days later, a three-judge panel of the United States Court of Appeals for the Fifth Circuit in New Orleans overturned part of Judge Kacsmaryk’s decision, allowing mifepristone to remain on the market with some restrictions.
The initial findings by Judge Kacsmaryk and the subsequent appeals court ruling were made applicable across the country, including states where medication abortion is allowed.
According to the limitations set forth by the Fifth Circuit’s earlier decision, mifepristone would have to be prescribed and distributed exclusively by a doctor, and the patient would have to pick it up in person and make three visits to the doctor while using the medication abortion. If those regulations had been followed, patients would not have been given mifepristone by mail.
Such a ruling could pave the way for many legal challenges to the FDA’s drug approval process. It can also mean all kinds of challenges to the agency’s approval of other medications and even enable the medical providers to contest the government policy.
Mifepristone has reportedly been used by more than five million women in the United States to end their pregnancies. And it has been authorized for use in dozens of other nations.
Why Did It Happen?
Plaintiffs in the case contend that mifepristone is dangerous and that the FDA’s approval procedure for the medicine was flawed. The FDA has strongly refuted those claims, saying that the medicine is extremely safe and effective. It highlighted several studies that suggest that significant problems are uncommon and that less than 1% of patients require hospitalization.
Judge Kacsmaryk stated in his preliminary judgment that the FDA had unlawfully authorized the medicine, thus ordering it off the market. He granted the agency a week to seek emergency relief before his final decision.
The Biden administration quickly appealed, and a panel of three United States Court of Appeals for the Fifth Circuit judges ruled that mifepristone would remain widely available as the case proceeded.
What Happens Next?
The case is now before the Fifth Circuit, where a different three-judge panel will hear oral arguments connected to Judge Kacsmaryk’s preliminary finding on Wednesday. The appeal process could take months as it moves through the courts. Any ruling made by the Fifth Circuit panel is likely to be appealed, at which point the case may be heard by all circuit judges. The losing party may then appeal to the Supreme Court after that. Until the Supreme Court intervenes or decides not to hear the case, access to the abortion pill will remain available.