


The Left is up in arms about a federal court ruling last week suspending the Food and Drug Administration ’s approval of mifepristone, a chemical abortion pill. There are legitimate criticisms to be made of the plaintiffs’ case, which include questions about the plaintiffs’ standing and whether the statute of limitations for the case has already passed. But the legal theory of the case is by no means extreme or abusive, as evidenced by the 5th U.S. Circuit Court of Appeals's partial denial of the Biden administration’s request for a stay of the district court’s order.
A three-judge panel of the 5th Circuit issued an unpublished order late Wednesday upholding parts of Judge Matthew Kacsmaryk’s nationwide injunction while striking down his broad suspension of the FDA’s 2000 approval of mifepristone.
The 5th Circuit panel decided that mifepristone could remain on the market — but only under certain restrictions. Mifepristone will now only be available through the seventh week of pregnancy; the drug must be prescribed by a licensed physician; women seeking the drug must have an in-person appointment with said licensed physician before receiving it; pharmacies may not offer the drug via mail-order; and prescribers must report nonfatal adverse effects of the drug to the FDA.
Each of these restrictions was originally put in place by the FDA itself and later rescinded via two regulatory changes — the first in 2016 and the second in 2021, during the pandemic. The plaintiffs challenging the FDA, which include four medical organizations and four individual doctors, argued that these drastic changes endanger the lives of women who will not be adequately informed of mifepristone’s risks, as well as the efficiency of emergency rooms that will end up treating many of them for adverse effects.
One of the criticisms of Kacsmaryk’s ruling is that these plaintiffs did not have adequate legal standing to bring the case in the first place. But it appears the 5th Circuit is persuaded that they do. This shouldn’t come as a surprise. There is plenty of legal precedent supporting both organizational standing and individual doctors’ ability to bring lawsuits on behalf of patients who are unable, for either physical or psychological reasons, to bring the case themselves. In fact, it’s this exact precedent that abortion advocates, such as Planned Parenthood, often cite when bringing challenges to abortion restrictions.
In this case, the 5th Circuit focused specifically on the individual doctors’ testimonies that they have treated many women who needed care after taking mifepristone, and the statistical evidence that proves women who undergo a chemical abortion are four times more likely to suffer adverse effects than those who undergo a surgical abortion:
We hold that on the record before us applicants [the FDA and HHS] know that hundreds of thousands of women will — with applicants’ own statistical certainty — need emergency care on account of applicants’ actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way.
However, the 5th Circuit does not appear persuaded that plaintiffs filed their case within the statute of limitations, though the panel acknowledged that plaintiffs “might very well prevail” on a full appeal.
The timeline here is a bit confusing. A challenge was filed against the FDA’s 2000 mifepristone approval in 2002. But the agency sat on this challenge for 14 years, when the FDA's own regulations required a response within 180 days, and waited to issue its response until March 2016. This means plaintiffs had six years from March 2016 — so, March of 2022 — to file another challenge. They did not file their challenge until November of 2022.
At the very least, the 5th Circuit agreed that plaintiffs’ arguments against the FDA’s 2016 and 2021 rule changes are both timely and relevant — thus, why the panel agreed with Kacsmaryk that they ought to be struck down. But the judges stopped short of endorsing Kacsmaryk’s interpretation of the reopening doctrine, a legal precedent that says if an agency takes action to remove safeguards or otherwise significantly change a regulation, then the original regulation itself can be reopened to a challenge.
This doctrine is admittedly narrow, but there is certainly a case to be made that the FDA’s decisions in 2016 and 2021 to abandon very basic safety precautions about the abortion pill call into question its ability to fairly regulate the pill at all. Indeed, the FDA’s watering down of nearly all restrictions on mifepristone is further proof that the agency is using the drug to push a political agenda. When the FDA issued its original approval of mifepristone in 2000, for example, it did so by classifying pregnancy as a “serious or life-threatening illness” and mifepristone as the treatment for it. This was a laughably absurd and egregious overreach.
It’s still likely that this case makes its way to the Supreme Court. But the 5th Circuit’s decision this week proves that the case has both merit and legal justification and that it is far more likely to succeed than the Left would like to think.
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