A major decision was just issued by the Fifth Circuit in the abortion pill case. This is the lawsuit filed by pro-life doctors challenging the Food and Drug Administration’s shifting safety standards for the use of mifepristone (a/k/a Mifeprex). It doesn’t resolve the case or change the status quo – the abortion pill remains available pending an ultimate decision by the Supreme Court. But it’s a major step forward.
Mifepristone is the abortion industry’s “magic bullet”, because it can be used in lieu of surgery for a very large percentage of abortions. Currently, over 50% of abortions are done with the pill.
The pill is also necessary for the abortion industry’s “Holy Grail” — “telemed” abortions, where the pill can be prescribed online and delivered to the mother by mail. That’s a crucial goal for them, because it would allow them to circumvent restrictive state or federal laws.
Four actions by the FDA were challenged in the lawsuit:
- The initial 2000 Approval of the drug, subject to certain safety protocols to protect patients : It can be used only up to 7 weeks of pregnancy, it must be dispensed by a doctor after an in-person evaluation, the pill must be taken at the doctor’s office, and an in-person follow-up with the doctor is required. Any serious adverse effects would have to be reported to the FDA.
- 2016 Amendments to the safety protocols – These expanded the time limit to 10 weeks, allowed non-doctors to prescribe, and required only one in-person visit to the office to receive the drug. It thus eliminated any requirement that the patient be seen personally by a doctor. They also removed the requirement that adverse effects be reported.
- The 2019 Approval of the generic drug – This allowed the use of the generic version of Mifeprex.
- The 2021 Decision to stop enforcing the in-person requirement – During COVID, the FDA suspended the in-person requirements of the 2016 protocols, thus permitting mail-order abortions with no in-person contact with any medical professional. This ultimately was formalized in 2023.
It’s very difficult to successfully challenge decisions by administrative agencies like the FDA. Courts generally show great deference to their alleged expertise, and the procedural requirements for a challenge can be daunting. You must establish that you have “standing”, which requires proof that you were actually harmed or are facing imminent harm from the agency’s action. You also have to bring the case within the statute of limitations. If you can get past those procedural hurdles, then you must prove that the decision was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
The first court to hear the case, a federal District Court in Texas, gave the pro-life doctors a stunning victory on all four of their points. That ruling would have taken mifepristone completely off the market. But an appeal immediately followed, and the Supreme Court issued a full stay of the District Court’s ruling, to allow for further litigation in the Circuit Court of Appeals for the Fifth Circuit.
After extensive briefing and oral argument, the Fifth Circuit issued its ruling yesterday.
The Circuit Court panel held that (1) the doctors lose on their challenge to the 2000 approval of the drug because the statute of limitations has passed and there are no grounds to extend it, and (2) the doctors cannot challenge the 2019 approval of the generic drug because they couldn’t show any injury to themselves from that decision, and thus lack standing. One judge dissented from these holdings and would have ruled that the doctors’ challenges on these points could go ahead.
But the court unanimously held that the doctors have standing to challenge the 2016 and 2021 decisions and are likely to prevail with their argument that the FDA decision was arbitrary and capricious. The court was bluntly critical of the FDA’s decision-making process and the shoddy evidence they relied on. It’s worth quoting the unanimous decision on this point:
- “It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.”
- “[FDA] relied on various literature relating to remote prescription of mifepristone—despite FDA’s admission that the literature did not affirmatively support its position.”
- “FDA candidly acknowledged that the literature was only ‘not inconsistent with [its] conclusion.’ In other words, the studies neither confirmed nor rejected the idea that mifepristone would be safe if the in-person dispensing requirement were removed.”
- “FDA concluded that the studies were ‘not adequate on their own to establish the safety of the model of dispensing mifepristone by mail.'”
- “Especially in light of the unreliability of the adverse-event data, it was not reasonable for FDA to depend on the published literature to support its decision.”
This is extremely important, because it demonstrates that the FDA is not free to act with impunity. It sends a message that they actually have to do their job and investigate all aspects of mifepristone and cannot just act as a rubber stamp for the abortion industry or a tool for pro-abortion politicians. It lays a strong groundwork for when the case goes to the Supreme Court for a final decision.
So this decision by the Circuit Court does not change the actual status quo – the pills can still be used up to 10 weeks of pregnancy, with no requirement of a personal visit, prescriptions can be made by non-doctors, and the pills remain available at local retail pharmacies. But it’s another strong step forward in the battle to protect the lives and health of mothers and children from shoddy and unsafe abortions.