How Will the Mifepristone Case Get Back to the Supreme Court?

On Friday evening, the Supreme Court granted a complete stay of the District Court's order in Alliance for Hippocratic Medicine v. FDA. And that stay will remain in effect while the proceedings in the Fifth Circuit continue. For now, the status quo continues. Justice Thomas would have denied the application for a stay. Justice Alito dissented from the Court's decision to grant the application for a stay.

Many press outlets reported that the vote was 7-2, but we cannot be so certain. For sure, there were five votes to grant the stay. It is also possible that 1 or 2 justices would have denied the stay, but chose to not indicate their dissent. (Will Baude flagged this possibility.) The timing of the case suggests that votes may have been in flux.  Originally, Circuit Justice Alito ordered that the temporary administrative stay would expire on Wednesday. But, before that deadline, the Court extended the stay until Friday. My guess is that there were potentially 3 or 4 votes for at least a partial stay, but Alito could not count to 5. Instead, the Court set the deadline for Friday night, so Alito could prepare his dissent. And, that release would ensure the order came after the close of business, when people would not be paying attention. (The Court has often issued emergency orders late at night on a Friday, after the news cycle is over.)

The Court did not issue any explanation for the stay. Perhaps five Justices thought that the Plaintiffs lacked standing for some, or all of their claims. Maybe five Justices thought that some of the claims were barred by the statute of limitations. Maybe five of the Justices thought all of the APA claims were unmeritorious. Maybe five of the Justices thought that the Comstock Act claims were unmeritorious. Maybe five Justices thought that the threat of irreparable injury to the government, and to the public, was so high that a stay was warranted while the litigation proceeded. But who knows? As we have been told incessantly, when the Supreme Court issues an order on the emergency docket, we do not know the Court's reasoning.

Let me air what will probably be an unpopular opinion on all sides. If a majority of the Court thought that this case is a loser on jurisdictional ground, then the Court should have issued a short per curiam opinion explaining why there was no jurisdiction. Nothing will change in the proceedings below with regard to jurisdiction. Either the plaintiffs have standing, or they do not have standing. The Court could have put the case out of it misery, and avoided dragging the lower courts, and the country, through what may be a fruitless exercise.

Adam Unikowsky writes that this order "makes it likely that the FDA will ultimately prevail in this case." Adam questions what more will be added by another round of briefing:

But their legal arguments, especially on standing, have been fully aired and I do not see how more thorough briefing would change the result. Moreover, it would be quite the bait and switch for the Court to flip on this a year from now

I agree with Adam. Nothing will be gained by another year of litigation. If a majority of the Court thought that this case is a loser on jurisdictional ground, nothing the Fifth Circuit will do can change the majority's opinion.

But the Court didn't explain its reasoning. Again, perhaps there was not a majority to coalesce around a single jurisdictional argument. Or perhaps the Chief Justice did his best ostrich impression, buried his head in the shifting sands, and hoped this issue would go away. (These issues never go away.)

What happens next? The case goes back to the Fifth Circuit. Oral argument will be held in 25 days, and counting. A panel has already been set, but the composition of that panel (as far as I know) is not public. Can the panel read any specific tea leaves from the Court's per curiam stay? Given that there are so many interrelated issues that go to jurisdiction and the merits, I think the answer is no. The only clear inference that can be drawn is that the government should prevail. That insight is not particularly helpful for lower court judges who are asked to resolve a concrete case.

There are a few paths going forward. First, the merits panel may agrees with all, or part of the stay panel's order. And that order can come quickly--maybe even this summer. The Solicitor General could file a quick cert petition, to get the case teed up for the long conference, for a decision by June 2024. But I think the more likely path is an orderly petition for rehearing en banc. Unlike Rahimi, where the government skipped en banc, here the SG will not be in a rush. The Supreme Court granted a stay for the entire duration of the litigation, so the status quo will remain. If a panel of the Fifth Circuit rules for the Plaintiffs, at least in part, I doubt that there are enough votes to reverse en banc. At most, dissents from denial of en banc could drag the process out a few months. So long as a cert petition is filed by November or December, the case can be added to the Court's docket for disposition by June 2024. Finally, there is a political advantage to dragging this case out for the government. Post-Dobbs, abortion has become a political liability for many Republicans. And the closer we get to the 2024 election, the more this case can become another problem for the GOP. But there is a risk of the case going beyond the election. (More on that risk later.)

There is a second path. A Fifth Circuit panel may rule for the government across the board. Again, I don't think there are many tea leaves to be drawn from the short per curiam order. But it wouldn't be hard for some of the more moderate members of the Fifth Circuit to toss the case on standing ground. At that point, the Plaintiffs can seek rehearing en banc. And I think there is a substantial likelihood that the petition is granted. But that process will take a lot of time. At least in the Fifth Circuit, the en banc process can take a year, or more. The majority en banc opinion on the Fifth Circuit are often very, very fractured, with several Justices writing concurrences and dissents. The upshot of seeking en banc would be that the case doesn't even get to a cert petition until late 2024, if not early 2025. The Supreme Court would not even touch the issue until after the change in administration.

And maybe that's the best plan for the plaintiffs. A future GOP administration could decide to take its own administrative action to roll back some of the Biden administration's changes regarding mifepristone. Specifically, a Trump or DeSantis FDA could reinstate the requirement that women have an in-person visit to receive this drug. No more telemedicine visits. And a future OLC could reverse the prior opinion concerning the Comstock Act, and prohibit shipping these drugs through the mail. We may also see criminal prosecutions for some people who potentially violated the act. (When the case first started, I always expected those two outcomes to be the most the plaintiffs could hope for.) Plus, don't forget the power of sue-and-settle with ADF. Conservatives can play that game also.

Thus, there is a double edged sword for the SG by dragging this case out. Indeed, if the administration flips, the Supreme Court may never even decide the case. That brings me back to my unpopular conclusion: If a majority of the Court thought that this case is a loser on jurisdictional ground, then the Court should have issued a short per curiam opinion explaining why there was no jurisdiction.

The Court declined this path. And the case may never even make it back to the Court. The game of 4D chess continues.

Comments

[dwshelf]

Despite being connected to abortion, this is not an ideologically driven case, at least not overall.

There's the national injunction angle.

It's easy to have a personal view regarding how the case should proceed, based on a half dozen different angles.

There's precedent to be respected, and there's precedent to (not) be set, the latter a trademark of Roberts.

Lastly there's what the law says or what the constitution says. Given the lack of more important agenda success, this could have carried the day, but that's muddled too.

So we're left with an unexplained mess of a decision.

[myself]

A group of physicians sue to stop a decades old drug, with an exemplary safety record, because they may at some point see an emergency patients who had complications from the the drug?

The plaintiffs have no standing according to current rules.

Much of the case is time-barred.

They're asking the court to override the FDA's scientific expertise regarding safety.

The only part that isn't completely ridiculous is the part pertaining to Comstock.

The case is completely ideological, if it wasn't abortion related you'd have trouble finding a lawyer to take it at all.

[Rev. Arthur L. Kirkland]

Clingers gonna cling.

Until replacement.

[Frank Drackman]

Milfeprestone came about 80 years too late for you, Jerry.

[QuantumBoxCat]

But what about the "judicial courage" displayed by Judge Kacsmaryk!?!

Or the "epicycles of abortion" that lead to a distortion of judicial procedure!?!

This was a let down Josh .... a real let down.

[Sam Bankman-Fried]

Life begins at 5 weeks and 6 days.

Governor Ron DeSextafficker

[John F. Carr]

If the Fifth Circuit takes the hint, it rules for the government and the case never makes it back to Washington.

[Zarniwoop]

Yep. What the 5th Cir does might still be up in the air, and will of course depend on the panel.

But I think that if the final result from the 5th Cir. (panel or en banc) is “No jurisdiction”, then there is no chance the S.Ct. grants cert.

[Dr. Ed 2]

Could the court be waiting for one of the other cases, eg the one where a state is being sued?

[Moderation4ever]

As it stands now it is unlikely there will be an administration change in 2024. The former President is a loser and his biggest competitor is losing ground fast. Unless the Republican cast a wider net, they can write off the Presidency in 2024. That means that the soonest an alternate administration could change rules on Mifepristone usage would be 2028. That is five years away and the shift in one year since Dobbs has been significant. In Ireland it took one woman's death to change the county's abortion laws, we could see that same change in 5 years.

[Area Man]

“If a majority of the Court thought that this case is a loser on jurisdictional ground, then the Court should have issued a short per curiam opinion explaining why there was no jurisdiction.”

That’s not how this works. The Supreme Court has appellate jurisdiction over such cases. It can’t rule on the issues in the case until those issues are appealed to it in due course. The issue here was whether the case should be stayed, not whether the parties have standing. If this were an original-jurisdiction case, that would be different, but it’s not.

[ah....Clem]

Thanks. I was wondering why the SCOTUS couldn't just remand on standing, and nodded along with JB when he wrote the above, but wondering why it would be "...an unpopular opinion on all sides..."

Well, assuming you're correct, it would be unpopular because that's not how any of this works. Might be nice if it did, but rules and processes and precedents matter. Well to those of us not named Alito, Oldham, or Kacsmaryk anyway.

[not guilty]

¨That’s not how this works. The Supreme Court has appellate jurisdiction over such cases. It can’t rule on the issues in the case until those issues are appealed to it in due course. The issue here was whether the case should be stayed, not whether the parties have standing.¨

Not so. Article III standing in the lower courts is a threshold determination which the Supreme Court must consider sua sponte. As SCOTUS opined in FW/PBS v. City of Dallas, 493 U.S. 215, 231 (1990):

Every federal appellate court has a special obligation to satisfy itself not only of its own jurisdiction, but also that of the lower courts in a cause under review, even though the parties are prepared to concede it. . . .

And if the record discloses that the lower court was without jurisdiction, this court will notice the defect, although the parties make no contention concerning it.

It is a long-settled principle that standing cannot be inferred argumentatively from averments in the pleadings, . . . but rather must affirmatively appear in the record. . . . And it is the burden of the party who seeks the exercise of jurisdiction in his favor, . . . clearly to allege facts demonstrating that he is a proper party to invoke judicial resolution of the dispute. . . . Thus, the petitioners in this case must allege facts essential to show jurisdiction. If they fail to make the necessary allegations, they have no standing.

[Citations and internal quotation marks omitted.]

[Area Man]

Your point is well taken. No doubt every court can review for standing whether it’s been raised before or not. To the extent my comment was too broad on that point, I revise it.

But does that apply to stay applications? I’m not aware of any appellate-jurisdiction case where the Court addressed standing when ruling on a stay application. It definitely could be out there, and I’m open to seeing and acknowledging it. But I’ve never seen it.

From what I’ve seen, the Court waits to address standing in regular (i.e., non-emergency-docket) cases. Standing is a factor in granting a stay because whether a party is likely to succeed is a consideration on whether to grant it. But that’s different from addressing standing outright.

If it were the case that the Court had to address standing in stay applications, in every case where standing was truly at issue, the party challenging standing would be seeking emergency relief and asking the Court to make a standing determination; and if you’re right, it would *have* to do so because “[e]very federal appellate court has a special obligation to satisfy itself not only of its own jurisdiction, but also that of the lower courts in a cause under review….”

Again, I’m open to counter-points and examples.

[ReaderY]

Agree and was going to mention this myself. The Supreme Court could indeed have decided the jurisdiction question at this stage.

I think not doing so, however, was the right decision here. Especially in highly controversial cases, the Court should avoid using the shadow docket to make ultimate dispositions. Ultimate dispositions should occur in regular order, after full briefing and argument.

Even though it seems pretty open and shut to me that AHA does not have standing, prudence and the need to maintain a stance of neutrality counsel for giving AHA an opportunity to make its case that it has standing with regular briefing and argument.

The NYTimes had a headline today saying the Court’s decision “sends a strong signal.” It does not and should not. Although the headline illustrates that it cannot avoid the world construing according to its wits, no matter what it does, the Supreme Court should nonetheless attempt to avoid even the appearance of using the shadow docket to send signals.

[Zarniwoop]

I think not doing so, however, was the right decision here.

Yep. While the S.Ct. might procedurally be able to say “dudes and dudettes, seriously, there’s no jurisdiction. Are you high?” to the D.Ct. and 5th Cir. (and they wouldn't be wrong!), this is a reasonably measured and prudential way to approach the question. Let the issue get fully steeped by (still expedited) briefing at the appellate level, then consider cert if necessary.

[Area Man]

If “[e]very federal appellate court has a special obligation to satisfy itself not only of its own jurisdiction, but also that of the lower courts in a cause under review,” then how could SCOTUS *only* address the stay and not standing? If it has such an obligation, then it *had* to address standing. Instead, it seems to me that it couldn’t address standing because the case—and therefore standing—wasn’t yet before it.

[Zarniwoop]

because in this rushed procedural stance, info might be incomplete. Maybe not incomplete, maybe incomplete … So let it percolate.

Look, I would personally support a “no standing, are you frackin’ high?” order to the 5th Cir. But I also understand why they want to wait for a fully-briefed and decided case to hear on appeal.

And again, if the 5th Cir. takes the hint and rules "yah no standing", then the S.Ct. just denies cert and dodges the issue. Which is where my money is at.

[Intelligent Mr Toad]

As I understand the case, if Kacsmaryk prevails, FDA's approval of Mifepristone will be rescinded.

So what? All the doctors will have to do is reapply. Mifepristone's decades-long track record virtually guarantee that it will be re-approved, possibly with even fewer restrictions on how it is used than it currently has.

And during the interim the doctors can use methotrexate.

[ReaderY]

Mifepristone’s approvability under current law is much more questionable. While in 2000 Roe v. Wade and progeny had declared all conflicting federal statutes unconstitutional and more or less mandated that government view abortion as a kind of illness of a sort subject to the FDA’s jurisdiction, after Dobbs the question of whether the FDA has any business approving abortion drugs is much less straightforward. The Comstock Act, which prohibits transporting abortifacients by mail or common carrier, would appear to control.

Abortion drugs would appear, after Dobbs, to be remarkably similar to euthanasia drugs. They are legal and considered “medical aid in dying” in some states. But the FDA does not regard it as its business to approve them, because the fact that human life is unwanted by the patient neither makes it a disease within the meaning of the FD&C Act nor overrides the FDA’s general statutory obligation to protect human life. After Dobbs, general-use abortifacients would appear to be in a similar legal situation to euthanasia drugs. After all, the outcry over thalidomide’s effects on fetuses was part of what had pushed Congress to strengthen the FD&C act. There’s a good legislative-history argument that Congress had had the safety of fetuses specifically in mind when it did so.

An APA proceeding concerns the legality of what the FDA did. I think there can be little doubt that in 2000 it was legal to approve an abortifacient, and what the FDA did at that time was reasonable. Roe v. Wade had gotten rid of the traditional contrary legal considerations. So I think AHA’s APA argument, even if they have standing (they don’t), has no merit. But an approval today would be another matter. With Roe v. Wade gone, considerations like the Comstock Act, the pre-Roe meaning of thr FD&C Act, etc. would weigh against an approval today.

[neurodoc]

"Mifepristone’s approvability under current law is much more questionable..." than it was years ago (when originally approved?) and why should its approvability be more questionable now under current law?

What are "euthanasia drugs"? Are they drugs given only for the purpose of ending a life or are they drugs that may hasten the end of life when that is the intended purpose. Morphine sulfate, a drug that has been around since long before the FDA came into existence. Its principle use is to alleviate pain, but at times it is used to ease a suffering individual's passage from the mortal coil, e.g., in the face of agonal breathing. Does such use make morphine a "euthanasia" drug in your view, or more importantly in the law's view?

Same question as to you understand by "abortion drug." Is a drug an "abortion drug" only when it is used to end a "viable" pregnancy, that is one that absent a pharmacologic or surgical interruption might be expected to produce a healthy baby eventually? You realize, don't you, that to facilitate expulsion of the products of conception after a woman experiences a "spontaneous abortion," a not infrequent occurrence, the woman's physician may do a surgical procedure (a D&C) or make use of mifepristone to accomplish the purpose. I don't know of any drug is exclusively an "abortion drug."

Also, because the FDA approves a drug to be used for a particular therapeutic purpose and according to its label provisions, that does not mean that physicians cannot prescribe said drug for "off-label" use.

Apart from the above, some of what you have said about unrelated matters (e.g., thalidomide; "legislative-history argument;" "the safety of fetuses;" etc. may be legally and/or medially correct, but I don't know what it would be.

[BTW, when you write, "...the fact that human life is unwanted by the patient neither makes it a disease within the meaning of the FD&C Act nor overrides the FDA’s general statutory obligation to protect human life...," are you in effect channeling the thinking of altar boy Matthew Kacsmaryk with a touch of Samuel Alito thrown in for flavor?]

[Commenter_XY]

Off label Rx-ing....neurodoc, that is a tough one. A Gordian Knot.

[ReaderY]

Doctors using approved drugs off label and against black box warnings is very different from the Supreme Court approving a drug specifically for the purpose. Your comment about the way euthanasia drugs are handled doesn’t contradict this difference. It illustrates it.

The two cases are in fact even more similar than I had said above. The use of opioids for euthanasia purposes violates the Controlled Substance Act. But just like the Comstock Act, the administration is choosing not to enforce it. But in part because of the Controlled Substance Act, the FDA will nonetheless not approve drugs specifically for euthanasia, and if it did the courts would likely strike the approval down given a suitable case (e.g. one that has standing). The status of euthanasia drugs in light of the Controlled Substance Act supports abortifacients being treated similarly, post-Dobbs, in light of the Comstock Act.

If Glucksberg had been decided differently, there would today be FDA-approved drugs specifically for euthanasia. The approval would have been made unquestionably lefal at the time made. But if, subsequent to that approval, a decision holding a right to euthanasia had been reversed, the Controlled Substance Act would again be good federal law, whether or not enforced, and euthanaisa drugs would be in pretty much the same legal situation abortifacients are today,

[ReaderY]

There is a difference cutting other way. Mifepristone today has NO approved use other than inducing abortion.

[neurodoc]

A non-person is a non-person, at all times, everywhere. While that should be self-evident, it may be a challenge for even some adults to grasp, especially those of the [i]ipsi dixit[/i} persuasion.

[Zarniwoop]

There is a difference cutting other way. Mifepristone today has NO approved use other than inducing abortion.

Incorrect. Mifepristone is a FDA-approved treatment for Cushing's syndrome, sold under brand name Korlym, dosage starting at 300mg/day. (The current dosage for pregnancy termination is 200mg/day; originally 600mg/day).

https://www.korlym.com/

[Zarniwoop]

Ope, the FDA approved current protocol for pregnancy termination uses a single 200mg dose of mifepristone (then followed by 800mcg misopristol), not "200mg/day" in the sense that that implies more than one dose or more than one day. Apologies for my poor choice of units.

But the bottom line is that the FDA-approved 300mg mifepristone pills for Cushing's syndrome would probably work pretty well in off-label use for ... pregnancy termination.

[Jason Cavanaugh]

You obviously do not understand the case if that is your conclusion as to the problems and consequences of the current ruling.

I suggest you read the filings next time.

[ReaderY]

Dismissing on standing grounds is a final disposition. The Court might have decided, I think with some reason, that it didn’t want to make a final disposition of a case this controversial on the shadow docket, without the benefit of full briefing and oral argument. It limited its decision to whether an immediate injunction was warranted. The stay allows the case to proceed in normal order. The Supreme Court can still order the case to be dismissed for lack of standing if the 5th Circuit finds standing and reaches the merits.

[not guilty]

I suspect that kicking the can down the road on standing was the price for Justices Kavanaugh and/or Bear It agreeing to the stay.

[Zarniwoop]

dumping the issue back to the 5th Cir. definitely makes sense. If the 5th Cir. follows the squarely on-point precedent and dismisses on standing grounds, the S.Ct. can simply deny cert and dodge the APA merits questions entirely.

[Rev. Arthur L. Kirkland]

Samuel Alito has become the bitter old man who turns down the Fox News volume just long enough to yell at schoolchildren for making too much noise on the playground a block away during recess.

[Frank Drackman]

Why so "Bitter" Jerry?? Did Sammy the "Knife" spurn your advances at Summer Camp?? At least Sammy's not cooped up at
https://www.cor.pa.gov/Facilities/StatePrisons/Pages/Greene.aspx
and boy, seems you're really interested in children's "Recesses"

Frank

[DaveM]

"Post-Dobbs, abortion has become a political liability for many Republicans. And the closer we get to the 2024 election, the more this case can become another problem for the GOP. But there is a risk of the case going beyond the election. ... The game of 4D chess continues."

This is such an unseemly example of how "politics" is placed above even life and death decisions. It is grotesque in the extreme.

"Government" knows nothing about freedom. It has no morals. It knows nothing of free agency. It doesn't have a concept of good or evil. Government is just a bureaucracy. An organized way to follow rules.

We mustn't cede the debate over the very meaning of humanity to bureaucrats, appointees and lawyers. They are nothing but servants of the existing order. They have a vested interest in the outcome of the debate, and thus should be silent.

My objection to abortion is on principle: it is unethical to declare anyone a non-person. "A person is a person, no matter how small." It is a truth so simple, even a child can understand it.

[Sarcastr0]

If the people know a thing, the government knows a thing. It’s part of the philosophical elegance of the Republican form of government.

Your principle is quote circular, as well. And has implications for miscarriages we don’t plan to follow, among other things.

[Zarniwoop]

My objection to abortion is on principle: it is unethical to declare anyone a non-person. “A person is a person, no matter how small.” It is a truth so simple, even a child can understand it.

If your ethics demand that you refrain from getting an abortion, that’s absolutely fine … just don’t have one. But you started with anti-government rhetoric:

“Government” knows nothing about freedom. It has no morals. It knows nothing of free agency. It doesn’t have a concept of good or evil. Government is just a bureaucracy. An organized way to follow rules.

Are you in favor of gov’t rules when they enforce your personal sense of ethics? Or are you OK with letting the pregnant person decide based on their moral sense?

[neurodoc]

A non-person is a non-person, at all times, everywhere. While that should be self-evident, it may be a challenge for even some adults to grasp, especially those of the [i]ipsi dixit[/i} persuasion.

[ReaderY]

Foreigners outside US territory are non-persons. The Supreme Court has regularly so held. If they were persons, we couldn’t deny them wntry to this country, or for that matter kill them, without a hearing. Yet we regularly deny them entry, we sometimes kill them in war and even by covert action. In a case in 2020 the Supreme Court reaffirmed the principle that foreigners outside US territory have no constitutional rights, calling it a bedrock principle of constitutional law.

Fetuses are in good company. More than 90% of the world’s human population arenmt persons either.

[SRG]

My objection to abortion is on principle: it is unethical to declare anyone a non-person. “A person is a person, no matter how small.” It is a truth so simple, even a child can understand it.

But that's sort of begging the question. Is a 6-week old fetus, about 5mm in length, a person in the same sense that a baby or an adult are persons? You assume that they are and then say it's unethical to deny it. And If I say to you that cats are persons, I can accuse you of a lack of ethics if you deny it.

[Frank Drackman]

Well they (Cats) sort of are (Persons) in the sense that the dead are reincarnated into various animals, (isn't that a Tenant of the Dolly Llama's "religion"??) haven't heard much from the Dolly lately, almost like he's been "Canceled"
And as the "Owner" of a Pomeranian, Ferrett, and Tuxedo (Cat), the Cat is way smarter than the other 2.
Frank "Fluent in Dog, Cat, and Ferrett"

[Frank Drackman]

On the one hand I'm happy, because most of the Milf-a-prestoned Fetuses will be those the Reverend likes to Gloat are "Replacing" Jewish Klingers like me, OTOH I'm unhappy, because Mrs. Drackman is a big Pro-lifer, and unhappy wife, lots of jerking off, On my Pimp-Hand, I'm a States-Righter, so let the Yankees abort their umm, "Replacements" (underrated movie BTW) and you know who doesn't really abort that much? Hispanics/Asians, so it could be worse (Pro-Life Blacks??, eek!!!!!!)

Frank

[ReaderY]

As I regularly point out, foreigners outside US territory aren’t persons either. The Supreme Court has held they do not have the constitutional rights that persons do in a series of cases from Johnson v. Eisentrager after WW II to Agency for Jnternational Development v. Alliance for Open Society International in 2020. When the Court said in Roe that the word “person” as used in the Bill of Rights lacks “prenatal application,” it used language almost identical to what it said in Johnson, when it held that the word “person” in the Bill of Rights lacks “extraterritorial application.”

Nobody, however, has so much as suggested that this line of cases means the FDA has no obligation ensure that (for example) clinical trials conducted abroad respect the safety of foreign-citizen patients. The FDA’s insistence that they do has had a considerably detrimental effect on the health of Americans. Clinical trials could be much faster and reach more definitive results if drug companies didn’t have to worry about the health, lives, or rights of foreigners outside US territory. Indeed, dying Americans have to forgo ready sources of life-saving transplant organs solely because of concerns like their being taken without proper consent.

And yet, rediculous as a personalist might find it, this is the situation. Foreigners outside US territory are no more persons for Bill of Rights purposes than fetuses are, and yet this doesn’t change the FDA’s statutory obligation to look out for their safety in the slightest.

So the idea that constitutional holdings about personhood for Bill of Rights purposes somehow control the FDA’s statutory obligations is simply a non-starter. The FDA regularly denies Americans access to life-saving medicines and transplant organs solely out of concern for the safety of constitutional non-persons. The FDA’s statutory obligation is to protect human safety, not constitutional-person safety. It has always been this way.