5th Circuit Abortion Pill Decision

On Wednesday, August 16, the 5^th Circuit Court of Appeals released its opinion after hearing oral arguments in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. This decision will probably be appealed because some of the older restrictions on the abortion drug (mifepristone) have been restored and the FDA under President Biden wants loose regulations on this drug.

The District Court’s decision was vacated in part and affirmed in part. The majority vacated the parts of the District Court decision discussing the original approval in 2000 and the part of the decision regarding the 2019 generic approval. The part of the decision discussing the 2000 approval was vacated because the majority ruled the statute of limitations had run and the part of the District Court decision discussing the 2019 was vacated because the majority found the plaintiffs were not harmed by that decision.

The 5^th circuit, like the other geographically based circuits, generally hears appeals in the first instance in 3 judge panels. After a decision is rendered, the losing party can appeal to the full panel of all of the judges on that circuit court or the party can appeal to the United States Supreme Court. The Appeals court next notes that enforcement of this decision is pending Supreme Court review of this case because of the order they issued in April. If the Supreme Court doesn’t decide to review this case, this decision will go into effect after the Supreme Court formally denies review.

The majority agrees the plaintiffs have standing to challenge some of the FDA actions. Plaintiffs’ injury is using this drug creates a risk that a surgical abortion will be necessary when the drug fails to starve the unborn child of nutrients, a surgical abortion is required to complete the process and the Court recognizes that because the plaintiffs disagree with abortion and don’t want to participate in it, they have standing; On page 59, the Court wrote the practical impact of this decision if it remains undisturbed on appeal:

Practically speaking, a stay means that—while the order is in effect— Danco will have legal authority to market and sell Mifeprex under the conditions that were in effect before 2016. Likewise, GenBioPro will have authority to market and sell the generic version of mifepristone under those same conditions—that is, those that appeared in the 2011 REMS. The in-person dispensing requirements, and FDA’s obligation to enforce them, will continue to apply.

The majority decided that the regulations that were in place in 2016 should be the regulations in place today including:

2016 requirements were	Desired 2021 revisions were
Only women whose pregnancies have a gestational age of forty-nine days or less are eligible;	Prescribing up to 10 weeks after gestation is fine
Only physicians can prescribe Mifeprex;	Non-physicians can prescribe
All prescribing physicians must be able to assess gestational age, diagnose ectopic pregnancies, and “provide surgical intervention in cases of incomplete abortion or severe bleeding” or have arranged for another physician to provide such care;	Because non-physicians can prescribe it and they may not know all of the signs of medical problems and risk of other problems is possible.
Prescription must occur in person; and	Mailing pills is acceptable
Prescribers must report any “hospitalization, transfusion, or other serious event[] to the sponsor.”	Prescribers must only report deaths

One judge on the Appeals court wrote separately to concur in part and dissent in part. The concurrence focused on why this section of the FDA’s rules (Subpart H granting accelerated approval) is entirely inappropriate for this drug because this section has specific requirements. Those requirements include a serious or life threatening illness, which pregnancy does not fit. Even the advocacy group that wanted this drug to be available in the United States recognized that accelerated approval isn’t the right path for this drug. On Page 64 of the opinion, the judge recognized the Population Council Letter to FDA at 1–2 (Sep. 6, 2000). “Neither pregnancy nor unwanted pregnancy is an illness, and Subpart H is therefore inapplicable for that reason alone.”

Although the majority recognized the standing of these Plaintiffs, the concurrence recognized they have another injury as well: aesthetic injury. The concurring judge reasoned that because aesthetic injury has been recognized as a legally protectable interest, the most famously recognition was in a 1992 Supreme Court decision. The concurrence here applies the same factors supporting aesthetic injury in environmental cases, support standing based on aesthetic injury here; on page 68, the concurring judge wrote:

“Unborn babies are a source of profound joy for those who view them. Expectant parents eagerly share ultrasound photos with loved ones. Friends and family cheer at the sight of an unborn child. Doctors delight in working with their unborn patients—and experience an aesthetic injury when they are aborted”

The concurrence disagrees that the original FDA approval is beyond challenge due to the Statue of Limitations for 6 years because the 2016 and 2021 decisions significantly altered the stakes of judicial review that they triggered the reopening doctrine. The 2016 revisions were not minor changes, but they changed the original safeguards surrounding this drug.

Because the FDA chose to use this subsection of their rules to approve this drug, and they didn’t follow their own rules back in 2000 and those subsequent decisions were based on the original approval, the concurrence would hold everything as unlawful. The FDA’s rules regarding accelerated approval require drugs to be approved that treat “serious or life-threatening illnesses”. Pregnancy however is not inherently an illness; women can have abnormal pregnancies that result in illnesses, but like old age the condition itself is not the problem that accelerated approval can be used to address.

For the reasons stated above, the concurrence would affirm the lower court entirely and rescind approval of the drug.

What is likely to happen now: the US Supreme Court will receive an appeal from either party and the Supreme Court will decide whether to hear the case. The drug still remains legal today because they have issued an order in April before the Court of appeals issued this ruling.

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