A Tale of Two Lawsuits

What you need to know about the abortion medication rulings

By Grace Haley

Last night two federal courts —one in Washington and one in Texas—issued conflicting rulings on mifepristone, one of the two drugs used for medication abortions. Matthew Kacsmaryk, the Trump-appointed federal judge in Texas, ruled to invalidate the FDA approval of mifepristone (with a stay of 7 days)—a decision we anticipated after the hearing earlier this spring. But a Washington federal judge, who also has the power to bind the FDA, ruled that the FDA shouldn’t restrict mifepristone and that the role of an Article III judge is not to second guess the expertise of the FDA. 

This is important: Both have equal bearing over abortion access going forward. And medically-safe sources of medication abortion pills, including mifepristone, are still available, despite the ruling out of Texas. Fear is just as strong of a tool in the anti-abortion movement as any legal ruling.

To get a clearer picture of what the two conflicting federal opinions mean and what the FDA and the Biden administration can do to protect mifepristone, Abortion, Every Day went to law professors Greer Donley and Rachel Rebouche—who have been leading the national conversation on abortion medication and the FDA approval process since Roe fell.

You can read our conversation below, conducted over email and edited for clarity:

We have two cases on mifepristone and the FDA, but the bulk of national attention is on the ruling out of Texas. How do these cases contradict each other?

Rachel: They are opposite results! The WA case looks at the copious evidence of mifepristone’s safety and decided that the FDA should maintain the status quo—that it could harm plaintiffs if the agency was ordered to take away approval. The TX case does its own fact—finding of mife’s safety and wrote that the drug is risky and harmful, counter to decades of research. It concluded that there’s a case to be made that the FDA should have never approved the drug 23 years ago. One case says keep mife on the market; the other says take it off.

Greer: The order in Texas was written specifically to avoid the FDA. It does not order the FDA to do anything; rather, it declares that the drug approval will be stayed after seven days (assuming an appellate court does not disagree). This was almost certainly deliberate. The court knew the FDA could use its powers to slow down the effect of an order if it was responsible for revoking the approval. The Washington order, on the other hand, orders the agency to maintain the status quo regarding the availability of mifepristone. 

The only way for the FDA to comply with both is through enforcement discretion. The Texas order ensures that in seven days (barring a successful appeal), mifepristone will become an unapproved drug. It will therefore be illegal to manufacture, market, or dispense it. Obviously, if the FDA enforces the statute against those who manufacture, market, or dispense mifepristone, then there will be a dramatic impact on the availability of the drug. The only way to maintain the status quo—as ordered by the Washington court—is to announce that the agency will not enforce the statute against parties who comply with the REMS. This should provide the safe harbor needed for those parties to continue their operations as normal.

Would you explain to our readers what enforcement discretion means for abortion access?

Rachel: It means that the FDA has the authority to decide how to enforce an action against a drug distributor. The FDA does not go after every unapproved drug on the market.

Greer: My co-authors and I have been arguing for a while that the FDA should use its enforcement discretion to protect access to mifepristone even if the Texas decision stayed its approval. But arguably, the Washington decision, which ordered the FDA to maintain the status quo, requires the FDA to use its enforcement discretion, at least in the states at issue in the litigation. At the very least, the Washington order provides enormous political cover for the agency to use its enforcement discretion, and we think the agency should do so.

Many argue that Kacsmaryk claimed a power he does not have by trying to force the FDA to revoke the approval of mifepristone. Can you explain what that means?

Greer: This is the first time in history that a judge has stayed an approval of a human drug over the objection of the FDA. There is a reason for this: when it comes to determinations of drug safety and efficacy, most Americans would rather have expert scientists and doctors make those decisions, not politically motivated judges. Moreover, Congress created the mechanism for the agency to revoke an approval of a drug. The process involves public hearings and an opportunity for the drug sponsor to object to the agency’s decision. Arguably, this is the only way a drug’s approval should be revoked. Without these processes, the drug manufacturer’s due process rights may be violated.  

Rachel: The Texas judge’s order actually asks the FDA to suspend the approval of mifepristone. But the court can’t tell the FDA how to do that.

What will this look like when this question of FDA approval of mifepristone ends up in the Supreme Court? 

Rachel: It will involve the larger question of the authority of federal agencies. These cases implicate more than just medication abortion access.

Greer: It will depend on which case is appealed and how the questions are posed to the Court. But I would expect the substantive holdings at issue in the Texas litigation to arise—in particular, whether the Comstock Act prohibits mailing pills and whether the FDA acted arbitrarily and capriciously when it approved mifepristone or amended the REMS.

What can the Biden administration do before then to protect abortion access?

Rachel: The FDA can issue clear guidance about how it will respond to these orders, and reassure prescribers and distributors that mife is safe and should be part of the medication abortion regimen.

Greer: The main immediate action is to issue an enforcement discretion notice. Longer term, I would want the FDA to consider removing the unnecessary and burdensome REMS that it has maintained on mifepristone. The court in Washington might eventually order the agency to do that, but the agency doesn’t need a court order to start that process. The FDA could also support [additional] litigation arguing that its regulation of mifepristone preempts state abortion bans. If successful, this litigation could pave the way to restoring some legal abortion access throughout the country. 

Going back to the Washington ruling, what will abortion access look like for the 18 states (including DC) involved in the attorneys general lawsuit? 

Greer: I think the FDA is effectively legally required to use enforcement discretion in those 17 states if it wants to comply with the court’s order. But I think that would be an odd outcome. If the FDA is going to use enforcement discretion, it should do so nationally. It will be exceptionally chaotic and confusing for the FDA to take a different enforcement approach in different states given that the drug distribution system is national in scope.

Rachel: The FDA should be precluded from taking mifepristone off the market.

Along with describing health care providers as ‘abortionists’ and describing reproductive rights as a form of eugenics, the Texas opinion gives recognition of constitutional fetal personhood, going further than the Dobbs decision. How steeped in anti-abortion rhetoric is Kacsmaryk’s ruling?

Rachel: The opinion reads like a brief by one of the anti-abortion amici. The language throughout the ruling tracks anti-abortion rhetoric.

Greer: It is heavily steeped in anti-abortion rhetoric. You can see it from the first page of the opinion. He refers to abortion providers as abortionists, he peddles in the false view that abortion is traumatic, he overstates the risks and downplays the benefits of abortion, he nods to fetal personhood. He made his biases clear.

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The short version? These rulings are not the final say. There are opportunities to protect medication abortion access that can be taken by the FDA, the Biden administration, GenBioPro (the manufacturer of mifepristone from the Texas lawsuit), and health care providers. The Washington litigation was important in part because it provided an important antidote to the Texas litigation, and similar efforts could be modeled after the case. 

Some more good news: Medication abortion providers have already confirmed that they'll be following FDA protocol first and foremost while they continue to provide mifepristone—whether through the mail and or health care providers. Whole Woman’s Health (an independent abortion provider) said in a twitter statement last night, “[W]e follow directives from the FDA, and not anti-abortion judges in Texas who lack any formal medical training. Whole Woman’s Health will continue to dispense Mife in our clinics and our Pills by Mail program for the next week as we monitor both decisions.” 

And Trust Women said, “Nothing has changed yet: medication abortions with mifepristone are still available.” Hey Jane, a virtual clinic that offers abortion medication, told their community last night that they would continue to provide their current mifepristone and misoprostol protocol and will monitor both lawsuits as they progress.

Amy Merrill, the digital director of Plan C—a nonprofit organization that provides resources for safe self-managed medication abortions—said, “Access to safe, self-managed abortion with pills in the US has not been—and cannot be—stopped.” 

We’ll have more coverage in the coming days, along with recommended reading on the cases in tomorrow’s Week in Abortion. Many thanks to professors Donley and Rebouche for taking the time to chat with us!

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