A recent Washington Post headline reads, “The Texas judge who could take down the abortion pill.” Another article from USA Today feverishly warns, “A Texas judge could soon force a major abortion pill off market nationwide.” A Denver Post headline ominously declares, “One Texas judge will decide fate of abortion pill used by millions of American women.”
While media headlines across the country declare a Texas judge has the power to ban the abortion pills nationwide, three leading legal experts say he in fact does not have that power.
“Actually, one Texas judge is not the final decision-maker on medication abortion,” wrote David Cohen of Drexel Kline School of Law; Greer Donley at University of Pittsburgh School of Law; and Rachel Rebouche of Temple Law School in a recent Slate article.
The case, Alliance for Hippocratic Medicine v. FDA, challenges the FDA approval of the abortion medication mifepristone. Abortion opponents argue the FDA unlawfully fast-tracked the approval of mifepristone in 2000 and did not have the required research to prove the safety of the drug under the labeled conditions of use. They also challenge the FDA’s recent decision to allow medical providers to mail abortion pills to their patients. Abortion opponents ask the court to rule that mailing abortion pills violates the 1873 Comstock Law, which banned sending obscene literature, contraceptives, abortifacients or any sexual information through U.S. mails.
The plaintiffs chose their judge by filing the case in a federal district with only one judge—Matthew J. Kacsmaryk—an anti-abortion extremist appointed by Donald Trump. For five years before becoming a federal judge, Kacsmaryk was deputy general counsel for First Liberty Institute, a Christian conservative legal organization that specializes in representing religious groups claiming they have experienced discrimination.
“Despite the barrage of predictions that this case could ban mifepristone and take it off the market, there are several basic legal principles suggesting that Judge Kacsmaryk’s power is limited and that a ruling for the plaintiffs will not necessarily change much at all with medication abortion,” wrote Cohen, Donley and Rebouche.
Ms. spoke to David Cohen about the case. This interview has been edited for length and clarity.
Carrie Baker: Can the Texas judge force mifepristone off the market?
David Cohen: A federal judge can only order the parties in a case to do things. The parties in this case are the FDA and one of the two drug manufacturers, Danco Laboratories, which makes the brand name mifepristone Mifeprex. The maker of the generic of the medication, GenBioPro, is not a party to the suit.
All that the plaintiffs are asking for is that the judge declare the approval of mifepristone was unlawful. They’re not asking for him to ban it, and he can’t ban it. There’s no mechanism for him to ban a medication. They can’t ask him to take it off the market. That’s not in his authority. He can’t go into any warehouse and confiscate anything. The FDA can, but that’s up to the FDA, just like it’s up to a police officer to enforce laws against going 55 when I’m driving 60.
Baker: Can the judge order the FDA to withdraw approval for mifepristone?
Cohen: No, the judge doesn’t have the authority to withdraw approval for a drug. Congress has a very specific procedure in the Food, Drug and Cosmetic Act for withdrawing drug approvals. He may order the FDA to follow the withdrawal process, but that withdrawal process leaves the final decision in the FDA’s hands. So if there’s any wiggle room in the judge’s order, they could interpret the ruling as a requirement to start this process. And then they start that process. That can be a lengthy process with them as the final decision maker.
Baker: If the judge rules the FDA improperly approved mifepristone, what does the FDA have to do?
Cohen: If the judge declares the drug was unlawfully approved, it’s now an unapproved drug. But it’s up to the FDA to enforce that. Judges can’t tell the agencies to enforce their laws. The FDA can decide that they are going to go after the distributor of the unapproved drug, or not. And if you look at their website, there are multiple documents that talk about unapproved drugs. The FDA has a risk assessment strategy in enforcing their laws. They don’t have the capability or the resources to go after every unapproved drug that’s out there, just like a police officer goes after someone who’s recklessly driving 60 miles an hour, but not me if I’m safely driving 60 miles an hour.
Baker: What is the range of possible FDA responses?
Cohen: It would totally depend on the specific wording of the order, but they could do nothing and then Danco would have to figure out if they are going to continue to market and distribute mifepristone.
Or the FDA could say publicly that this is an unlawful drug, and now we are going to consider Danco and GenBioPro to be distributing unlawful drugs and we’re going to come after them with the fullest extent of the law. I sure hope that the Biden FDA would not do that. But they could.
The FDA could also issue an enforcement discretion letter and say that we are using their enforcement discretion to not enforce the law against these companies because mifepristone is an entirely safe drug even though it is now unapproved because of this decision. The FDA has used its enforcement discretion before to not enforce the law against companies distributing unapproved drugs.
Baker: Could the FDA allow mifepristone to be prescribed as an unapproved drug?
Cohen: If the FDA declares publicly or just by its actions indicates that it’s not going to go after GenBioPro and Danco and they are comfortable enough with that, then they can continue to distribute and market mifepristone. I don’t know what they’re going to do. I want to make that entirely clear. I don’t know what the FDA is going to do. I don’t know what did GenBioPro or Danco are going to do.
Baker: Would the ruling bind medical providers?
Cohen: The FDA does not regulate doctors. Doctors are not parties to this case. So the doctors would have to determine under their own state law and their scope of practice for their license if they are allowed to prescribe this drug.
My understanding is that most states allow doctors to prescribe unapproved drugs as a matter of course. The FDA’s authority is to go after the distributor, not doctors. Unapproved drugs are a part of American medicine. It does raise risks for malpractice lawsuits if you are prescribing unapproved drugs. I’m not saying this is something that is without any legal risk, but it’s not against FDA law for doctors to prescribe unapproved drugs. It would be up to their state law.
Baker: So the impact of the ruling is up to the FDA and the drug companies?
Cohen: The judge is not being asked to ban the drug. He’s not being asked to take it off the shelves or off the market. He’s not being asked to bind any doctors. He’s not being asked to bind you or me or any patients. It’s very important that we are clear about what the ask is and what his power is.
The ruling may result in mifepristone being taken off the market. Absolutely. If the FDA is scared of the political pressure of not acting on an unapproved drug and Danco says, it’s too risky, we’re going to take it off the market, that may be the result. But that’s not a necessary result. And we shouldn’t say that it’s the judge who’s doing this.
Baker: If the court rules the approval process for mifepristone was unlawful, could the FDA re-approve the medication?
Cohen: I think the drug manufacturer would have to re-petition. I don’t have any inside knowledge, but I would just imagine that the drug companies are ready to re-petition the FDA for approval. Now, how long that would take I don’t know.
A lot will be determined by the FDA, GenBioPro and Danco. This judge does not have the power to ban prescription of the drugs. He does not have the power to actually take it off the shelves.David Cohen
Baker: What is the danger of appealing a bad ruling?
Cohen: The potential for the appeal is very dangerous because it broadens the impact of whatever ruling there might be on the Comstock Act. And then you know, the Fifth Circuit is super scary when it comes to abortion. There’s no doubt about that. But I think, you know, this is one of those situations where both things can be true at one at the same time.
This is a very scary case, it is very important. It’s probably the most important post-Dobbs case. And it could have really serious effects and change abortion care nationwide. At the same time, the judge’s power in this case is very limited. A lot will be determined by the FDA, GenBioPro and Danco. This judge does not have the power to ban prescription of the drugs. He does not have the power to actually take it off the shelves.
Baker: When do you think a ruling could happen?
Cohen: My understanding is people have seen in the past that this judge’s rulings have come out very quickly after briefing has closed. And so there was concern he would do that here.
Now, it’s possible that the public pressure just made it seem like that would be totally illegitimate for him to rule so quickly. So, you know, maybe that accomplished that, but I don’t know.
Baker: The plaintiffs are also asking the judge to rule that mailing abortion pills violates the Comstock Act. Would this apply nationwide?
Cohen: No. All he can do is bind to the parties in the case. So if he says that the Comstock Act prohibits mailing mifepristone, his ruling only binds the FDA. He could also apply it to Danco. They’re the only parties that have to follow his ruling about the Comstock Act. You, me, doctors, GenBioPro—no one else is bound by his ruling about the Comstock Act. Because district court judges just don’t have the power to bind anyone except for the parties before them.
Baker: Could this ruling also apply to misoprostol, which can be used alone to end early pregnancy?
Cohen: The judge is ruling about the Comstock Act in a case involving Danco, which only mails mifepristone, and the FDA, which doesn’t mail anything. The judge doesn’t have mailing of misoprostol in front of him. There is no entity that’s mailing misoprostol before him that could be bound by his order.
Baker: What’s the most important thing to know about this case?
Cohen: We don’t have to give the judge more power than he has. As someone responded to my tweet thread about this, we don’t need to pre-comply with fascism. And you know, that’s probably an extreme way to say it, but I completely agree with that sentiment. We do not have to comply ahead of time. There are methods of resistance. There are methods to fight back. There are methods to get around this. And I think that’s really important to think of it that way.
Baker: What can people do to keep mifepristone on the market?
Cohen: The FDA needs to be clear that there are a lot of options they can follow. If we want mifepristone to remain available, then we need to put pressure on the FDA to make sure they take the right approach, which is to use its enforcement discretion to allow mifepristone to remain on the market.
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