The Supreme Court should make the FDA do its job before it exercises power.
The Supreme Court should make the FDA do its job before it exercises power.
C onsider the following situation. The Food and Drug Administration approves, for the first time, a controversial use of an existing medication with no supervision by a doctor. Take as an example the use of hydroxychloroquine to treat Covid. There are publicly reported deaths of its users, yet the FDA has also pared back the data that doctors need to report about adverse effects — data that the doctors may not even observe because they’re not seeing the people taking the drug. States try to ban the drug, but corporations are still mailing it to their residents for profit, so the states go to court to challenge the scientific basis of the FDA’s approval. When called out, the FDA admits that it didn’t study the issue, but never fear, it’s studying it now.
The states ask for a court order stopping the new regulation while the question is being studied. Sure, they say, the FDA may be entitled to some presumption that its scientific studies are valid when somebody challenges them — but here, they’ve admitted in court that they didn’t do any studies, and studies are the FDA’s whole thing. This isn’t like some policymaking agency that is permitted to enforce presidential policies based on its own moral and practical intuition and the experience of its agents in the field and can wait for the data to back it up. The FDA’s powers derive from empirical, scientific studies. So, if the agency hasn’t done the studies, it should have to wait to act until it has. In the meantime, the usual presumption applies: States have the police power over the health and safety of their residents unless and until there’s a valid exercise of federal authority to override it.
In short: the court should tell the FDA it can come back and seek to apply its regulation after it has done its homework, and not until then.
This is what’s happening in Louisiana v. FDA, Louisiana’s current lawsuit to block the Biden-era FDA’s rules on the mifepristone abortion pill. On Friday, a unanimous panel of the Fifth Circuit stayed the 2023 Biden rule, which eliminated any in-person doctor visit in dispensing the pill — a safeguard the agency had once touted as essential. That rule change has real consequences. This morning, in a pair of identically worded summary orders at the request of the two drug companies that manufacture the pill, Justice Samuel Alito lifted the stay for a period of a week to give the Supreme Court time to consider the Fifth Circuit’s order. This is an administrative stay; because Alito sits as the circuit justice for the Fifth Circuit, the author of Dobbs appears to have issued it on his own authority without formally consulting the rest of the Court. (Whether he talked to his colleagues to sound them out, we can’t know.)
The Dogs Not Barking
Let’s start with what’s not going on here.
First, the stay request that has advanced through the Fifth Circuit to the Supreme Court doesn’t ask those courts to ban the pill entirely from the market but simply to restore the pre-2023 rules for dispensing it, which required a single, in-person doctor visit. This also means that Louisiana isn’t trying to navigate the uphill statute-of-limitations fight involved in challenging the pill’s original approval in 2000.
Second, the case isn’t brought by doctors, so it doesn’t have the same standing-to-sue issues that doomed a similar challenge in FDA v. Alliance for Hippocratic Medicine (2024). Louisiana has laws against using the pill to commit homicide against an unborn child, and allowing the pill to be mailed into the state without the participation of a Louisiana-licensed doctor undermines its ability to enforce that unquestionably constitutional law.
The Fifth Circuit found that Louisiana had standing, and noted that the Biden FDA had avowedly acted on the basis of a post-Dobbs presidential executive order that aimed to ensure access to abortion even in states that banned it — thus a direct federal effort to undermine the state’s sovereign enforcement of its own laws, which the Supreme Court had just found to be constitutional. As the court concluded, “the 2023 REMS [the Biden FDA regulation] sanctions and facilitates conduct with the express purpose of undermining Louisiana’s legal restrictions on abortion. The regulation creates an effective way for an out-of-state prescriber to place the drug in the hands of Louisianans in defiance of Louisiana law.”
There are real public costs to states when women are taking drugs with known, potentially dangerous effects without medical supervision. The Fifth Circuit likewise found that the Biden FDA’s actions created a direct cost for Louisiana: “Louisiana identifies $92,000 it paid in Medicaid costs from two women who needed emergency care in 2025 from complications caused by out-of-state mifepristone. Such costs will almost certainly continue because nearly 1,000 women monthly — many of whom are on Medicaid — have mifepristone-induced abortions in Louisiana.”
Even the Biden FDA admitted this: “FDA’s 2023 mifepristone label reports that 2.9 to 4.6 percent of women prescribed mifepristone in-person will require emergency care.”
Third, the stay request is also narrowly focused on the scientific basis for the FDA’s approval of the 2023 regulations. It does not raise the issue of whether sending abortion drugs through the mail is illegal under federal law (18 U.S.C. §§ 1461-62, commonly known as the Comstock Act). The Justice Department, if it wanted, could still stop the mailing of these pills (at least into states where their use is illegal) on the grounds that it is currently a federal crime. Louisiana isn’t trying to have that fight.
Fourth, the Fifth Circuit’s entry of an effectively nationwide stay of the FDA rule doesn’t collide with the Supreme Court’s disapproval of nationwide injunctions in Trump v. CASA, Inc. This case was brought under the Administrative Procedure Act, and the Court didn’t rule on the geographic scope of the APA’s explicit statutory mandate to courts to “set aside” unlawful agency action, a power that (unlike the power at issue in CASA) is statutory rather than inherent in the judicial power and that is hard to read as anything but a congressional warrant to halt agency actions on a nationwide basis.
Fifth, like the 2016 challenge to the EPA’s Clean Power Plan, this case doesn’t (at least not yet) involve the frequently invoked (by the Trump administration) question whether the federal government suffers irreparable harm if it can’t enforce its own laws, rules, and executive branch policies. Irreparable harm is what the party seeking a stay must show — so, at the Fifth Circuit, that burden was on Louisiana. At the Supreme Court, the shoe is on the other foot — but thus far, only the drug manufacturers have filed to ask the Court to restore the effectiveness of the FDA rule. The Trump FDA hasn’t been heard from yet. It will be under a lot of cross-pressures from its own institutional interests to defend the rule and from increasingly dissatisfied pro-lifers not to. At the Fifth Circuit, the FDA didn’t even bother to defend the Biden-era FDA rule on its merits, arguing instead on procedural grounds against the stay and urging the court to give the FDA time to do its own review. The justices may well put the solicitor general’s office on the spot by requesting its input.
Come Back When You’ve Done Your Research
Once we focus on the narrow question that will come before the Court next week, we see why the Fifth Circuit stayed the rule. The court found — unsurprisingly, given the lack of studies and the fact that the current FDA isn’t even defending the rule — that Louisiana is likely to win its suit on the merits. That’s always the most important factor, in practice, to granting an injunction, stay, temporary restraining order, or other emergency relief. As Louisiana’s brief on appeal summarized how prior Fifth Circuit panels had reacted to the double-barreled action of the FDA in removing safeguards while paring back reporting requirements on adverse events:
FDA based its removal of the in-person dispensing requirement on the absence of data that FDA had only five years previously intentionally eliminated, using that absence to justify deeming mifepristone safe without an in-person dispensing requirement. . . . This Court was astounded by FDA’s “declaration that the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’ . . . This ostrich’s-head-in-the-sand approach is deeply troubling,” the Court said. . . . “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” — and thus “it is unlikely that plaintiffs’ arbitrary-and-capricious challenges will fail on the merits.” [Quotations and citations omitted]
“This,” the Fifth Circuit concluded on Friday, “is a textbook example of arbitrary and capricious agency action.”
Finding that Louisiana’s harms — the ones that gave it standing to sue — were irreparable, the Fifth Circuit turned to the balance of equitable considerations. The court was unpersuaded that the drug companies couldn’t comply with the pre-2023 rules: “a stay would only pause a method of prescribing mifepristone that began five years ago and was formally approved only three years ago.” More to the core of the dispute, the court found that the FDA’s current review of the issue was no reason to let it keep in place a previous rule that the agency itself couldn’t and wouldn’t defend in light of its lack of basis in studies or data:
We have now three times found that the agency’s progressive relaxation of mifepristone’s guardrails likely lacked a basis in data and scientific literature. FDA itself now concedes the regulations were marred by “procedural deficits” and a “lack of adequate consideration.” The public interest is not served by perpetuating a medical practice whose safety the agency admits was inadequately studied. Indeed, the public interest demands the opposite. . . .
The district court emphasized the importance of FDA’s being able to “complete a fulsome review” and “proper science-driven evaluation” of mifepristone protocols. Again, quite true. However, this challenge involves the existing 2023 REMS, not FDA’s ongoing review. Granting a stay would do nothing to prevent FDA from completing its review of mifepristone’s safety protocols.
And consider what spurred that review: the agency’s concession that its prior evaluation of mifepristone — including the 2023 REMS — was marred by “procedural deficits” and a “lack of adequate consideration.” As Louisiana points out, it “makes no sense to deny preliminary relief on the grounds that agency action is so unlawful that the agency openly concedes a review is necessary.” That would mean an agency could forestall judicial review of admittedly unlawful regulations merely by promising to review them in the future. And here FDA cannot even say when its review will conclude — perhaps over a year from now because it has not finished collecting data.
Quite so. Louisiana isn’t asking to stop the FDA from asking the right questions, or from answering them. It’s just asking the courts to tell the agency to stop acting as if it has the answers before it even starts asking the questions. That’s not the FDA’s job. And so long as we have the APA, courts are well within their authority to require it to do its job first, then exercise the powers that flow from doing so second.