What would happen if the FDA refused to follow the order on mifepristone?

Question

Yesterday a Texas judge said the FDA’s 2000 approval of mifepristone – one of the drugs used to terminate a pregnancy – must be halted.

What would happen if the FDA said they refuse to follow that order?

Answer 1

News update: This decision is being appealed. This answer will go out of date.

Further news update: Supreme Court has ordered a stay on the injunction. While we don't know yet, this usually signals they will take the case, which will most likely resolve the split.

The analysis below contains two "speed"-ish assumptions:

• SCOTUS has not yet resolved the curcuit split
• No new law as passed that changes the state.

The current status of the FDA's approval of mifepristone¹ is a court split in two different courts with dueling injunctions. Two judges in different circuits; neither of which can overrule the other, have issued opposed injunctions against the FDA.

When this happens at the district level; as a matter of law, the appellate court must resolve this. The affected should file for an emergency hearing to avoid contempt of court. However this does not work as a matter of law in different circuits. Neither circuit can directly overturn the other's ruling and the supreme court can only be compelled to hear a case in certain limited constitutional situations, none of which are in play here. (And even if we could compel the supreme court to hear it, the supreme court is capable of deadlocking due to a 4-4 ruling while trying to resolve a circuit split.)

Since the current situation is a known unresolved problem in procedural law; this is currently a matter of politics. Nobody actually believes the answer to dueling injunctions is "do what you want". Previously in the news there were headlines about splitting the action by state. That's a political decision, but not a terribly bad one.

I have previously approached problems like this one from the other direction. Does dividing the law itself by circuit create a problem. In this case I'm reasonably sure the answer is no. I cannot come up with a threat model where it being available in one district causes a risk to a district where it is not available, because as a prescription drug, providing it to other than the intended is already a crime. This presents a plausible political decision of let both rulings stand and constrain the rulings to the circuits they originated in. For the rest of the circuits; an action can be forced to issue a ruling to decide which way it will go in that district.

Another plausible answer is to do exactly what the headline said and break it down by state. The FDA's position as the sole authority stands challenged by several states (see medical marijuana and right to try acts). Would it be that crazy if the states claimed a constitutional issue under the theory of the Federal Government has enumerated powers to override individual FDA decisions by writing direct law? Probably not. I can see a lot of political pressure being brought to bear on this issue because of the use of the drug in question; but for arbitrary drugs the states decisions to allow certain drugs the FDA had not permitted (or outright banned) became a thing that was done. In the right to try cases it appeared the FDA didn't act out of something that looks like laziness, but in the marijuana cases it would appear that the result of a trial by jury was feared.

In politics, the power often ends up being where the people believe it is. This too is a plausible result. If the states say change it, and the people believe the power is with the states to change it, than the power is with the states to change it.

1: I am not discussing which ruling is right in this answer.

Answer 2

They would be following the order of a different court that prevents them from making any changes on the status of that drug.

Judges' dueling decisions put access to a key abortion drug in jeopardy nationwide

Within hours of that decision, U.S. District Judge Thomas O. Rice issued a ruling in a separate case in Washington state. That lawsuit filed by a coalition of Democratic attorneys general in 17 states and the District of Columbia sought to block the FDA from pulling the drug from the market.

Rice's decision blocks the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone."

Answer 3

Well, the government appealed the Texas decision. Then, a 5th Circuit panel overturned in part the injunction by the Texas judge. In particular, the part where the original [2000] FDA decision had been deemed "reopened" was overturned (the panel ruled that the statute of limitations on challenging that had indeed passed/expired), but the rest of the injunction against the more recent FDA changes [2016+] which had broadened access to that drug were not overturned by that 5th Circuit 2-1 panel decision.

But the government was not satisfied with even with that result and appealed to SCOTUS, which temporarily stayed the whole [Texas] order, but this is really a very short term measure, as it expires on April 19. Journalists have suggested that SCOTUS intends to provide a fuller response next week.

It's hard [for me] to speculate what the outcome of that might be. On one hand, even [sitting] conservative supreme justices like Alito have previously sided with the FDA's preemption of state regulations on medications. On the other hand, the Texas' judge decision appears tailored to appeal to the recently [SCOTUS] minted major questions doctrine, because [it] asserts e.g. that "Pregnancy is not an illness" (p. 40) and that (p. 44) "Chemical Abortion Drugs do not provide a Meaningful Therapeutic Benefit", so that this drug should be held to a higher safety standard than the FDA decided. And, of course, we know that SCOTUS recently overturned Roe. v Wade, so the conservative majority thereof might be persuaded by such arguments on pregnancy.

On the enhanced access issue, even the 5th Circuit was miffed by FDA's decision to disregard their prior black box warning for this drug, which is essentially why they decided to not stay that part of the Texas injunction. So the FDA/government has much more of an uphill battle in that regard.

Finally, the FDA is actually very little on the hook here. SCOTUS has previously decided (in Heckler v. Chaney) that the FDA can do selective enforcement of its own rules/prohibitions (particularly wrt. drugs used for the death penalty--which is hardly therapeutic either.) Furthermore, SCOTUS even ruled that that kind of FDA decision is not even subject to judicial review! It's more the case that manufacturers like Danco will have a tough time deciding what to do if they don't get official cover from the FDA, but will be subjected to contrary decisions at state level.

Also, if SCOTUS rules that regulating pregnancy termination drugs isn't clearly spelled out in FDA's mandate, it's entirely possible that [a future] Congress could make that more clear by law. There is in fact recent (2023) precedent for Congress doing that with respect to medical devices [for specific uses], after the FDA lost an appeal on that. Whether the current Congress has the majority/inclination to do something like that for pregnancy termination drugs is an interesting question that I won't try to address here.

As for the other decision mentioned in the accepted answer:

The DOJ asked [Judge] Rice earlier this week to clarify by Friday what the government’s legal obligations are under his order because it sees “significant” tension with Kacsmaryk’s decision. Rice said on Thursday that Kacsmaryk’s order and the 5th Circuit ruling have no bearing on access to mifepristone in the 17 states and D.C.

So, the FDA had legal license to ignore the 5th Circuit decision in those 17 states + DC (which seem none were in the 5th Circuit). But Rice can't issue a decision escaping SCOTUS, of course.