A Texas federal judge He will consider whether the U.S. government should be blocked from approving the drug for medical abortion at a high-stakes hearing on Wednesday.
case, Brought by pro-abortion doctors and medical associations, It’s arguably the most significant legal battle over abortion since the Supreme Court overturned Roe v. Wade last summer to end abortion protections nationwide.
According to the way U.S. District Judge Matthew Kacsmaryk handles the medical abortion lawsuit, it could cut off the nation’s most common abortion method across the country.
Ministry of Justice and external legal experts explain If the plaintiffs ask Kacsmaryk to do so, it would be “unprecedented” for the US district court to order the FDA to revoke the drug’s approval. The drug — mifepristone — was approved by the FDA more than two decades ago, and the plaintiffs have also challenged the agency’s recent moves to make abortion pills more accessible.
Ahead of Wednesday’s Kacsmaryk, the challenger requested a preliminary injunction that would force the FDA to withdraw or suspend the approval at the conclusion of the lawsuit.
The hearing will begin at 9 a.m. Central Time and is expected to last several hours. While it will be open to the public, the hearing will not be broadcast live.
Here are the takeaways from Wednesday’s hearing:
The challengers, represented by prominent anti-abortion legal groups, argue that the FDA violated administrative law in the process of approving mifepristone and in loosening rules on the drug’s use over the years.
“After 20 years of fruitless engagement with the FDA, the plaintiffs are now asking this court to do what the FDA has and is legally required to do: protect women and girls by unlawfully holding, setting aside, and revoking FDA-approved chemical abortion medicines, and Those receiving this dangerous drug remove important safeguards,” the complaint reads.
Critics of the lawsuit include many mainstream medical organizations that filed amicus briefs in support of the FDA, say plaintiffs used misleading and carefully selected evidence It is unsafe to argue that mifepristone is unsafe.
“The scientific evidence supporting the safety and effectiveness of mifepristone is overwhelming. Mifepristone is one of the most studied prescription drugs in the United States and its safety profile is comparable to that of ibuprofen,” said a group of leading medical and public health societies Write to the court in one such brief.
Mifepristone is the first drug A two-pill regimen for termination of pregnancy. If it is no longer available, wait times at brick-and-mortar clinics could increase significantly in states where abortion is legal. Democratic attorneys general said in a brief that the clinics have been stretched to capacity by the flood of patients coming from states where abortion is illegal.
Kacsmaryk before joining the bench Working that suggestion against abortionn He is an attorney at a conservative law firm that specializes in religious freedom cases.
The case before him, however, is not just about abortion, but about administrative law and the extent to which FDA practices can be second-guessed in court.even some conservative legal scholars express doubt Arguments against Plaintiff.
Kacsmaryk considered a full trial on the merits of the lawsuit before deciding on a preliminary injunction, but ultimately backed away from that route, which would limit the evidence presented to him on Wednesday.
Before Kacsmaryk can understand the merits of the challenger’s arguments, he must weigh several procedural issues that may limit his ability to intervene in the dispute.
In instructions to attorneys ahead of the hearing, Kacsmaryk told them to be prepared to answer several questions about whether the challengers had determined that they had been harmed by the FDA’s action, making it appropriate for the court to intervene. In addition, some have questioned whether the judge can unilaterally withdraw the drug from the market in practice.
There are specific legal procedures for how and when the FDA withdraws a drug, and it’s unclear whether the FDA would have to go through those steps if a court ordered the withdrawal of an approval — which could take weeks or even months.
There is also the question of how Kacsmaryk’s order will affect the behavior of providers prescribing mifepristone and the behavior of manufacturers and distributors who are not parties to the case. (A pharmaceutical company that manufactures and distributes mifepristone stepped in as a defendant, but another major manufacturer did not.)
Kacsmaryk has asked attorneys to be ready to debate what remedies would look like if he ruled in favor of plaintiffs.
Listed in the case as an attorney for the legal advocacy group Alliance Defending Freedom representing the plaintiffs is Erin Morrow Hawley, wife of Republican Senator Josh Hawley. Morrow Hawley). However, the main signatory to many of the ADF’s briefings is Erik Baptist, another of the group’s lawyers.
Kacsmaryk gave each side two hours to argue the case. Some of the Justice Department’s time may be shared with lawyers for the intervening pharmaceutical company Danco. The challenger’s lawyers will be on the floor first, and they will be allowed some of the two hours for rebuttals after the defendants have had a chance to present themselves to the judge.
It was always possible that Kacsmaryk would rule on the preliminary injunction from the bench during the hearing. But that’s unlikely because of the high-profile nature of the case and the breadth of topics the judge is asking lawyers to prepare for arguing.
When he does issue a ruling, if it is an order in favor of the challenger, he can voluntarily suspend the order, giving the DOJ time to appeal to the conservative-leaning 5th U.S. Circuit Court of Appeals. If not, the department is expected to ask him, as well as the appeals court, to do so.
If Kacsmaryk denies the plaintiffs’ request for a preliminary injunction, they will also have the opportunity to seek immediate intervention from a higher court.
It will also be interesting to see whether Kacsmaryk addresses the death threats his court received and his botched attempt to minimize publicity during Wednesday’s hearing.
On Friday, Kacsmaryk held a private conference call with lawyers for the case to discuss scheduling the hearing and logistics. However, during the call, which was not on the public schedule at the time, Kacsmaryk said he would delay publicly announcing Wednesday’s hearing “to minimize some of the unnecessary death threats, voicemails and harassment the department has received.” .The beginning of the case.”
He asked the lawyers not to make the matter public themselves, but the hearing — and Kacsmaryk’s plea to keep the plan confidential — was heard by Washington post Saturday.
As legal experts and media organizations criticized his secrecy for undermining principles of judicial transparency, Kacsmaryk announced the hearing on Monday. But his order did not say why he was trying to keep it secret, and it was unclear whether the spat would be brought up in Wednesday’s lawsuit.
Kacsmaryk said the court received “a barrage of death threats” and harassing phone calls, according to minutes of Friday’s status meeting obtained by CNN.