The high-stakes hearing, for which the judge has allotted up to four hours, will be the first time the judge engages directly with lawyers for the Justice Department, representing the FDA; the company that manufactures and distributes the drug; and the antiabortion group challenging the medication. Kacsmaryk could rule at any time following the hearing, potentially disrupting access to the widely used drug, including in states where abortion is legal.
If Kacsmaryk sides with the plaintiffs, it would be the first time a court has ordered the government to withdraw or suspend approval of a medication despite opposition from the FDA and the drug’s manufacturer.
Medication-induced abortion has become increasingly contentious since the Supreme Court’s conservative majority overturned Roe v. Wade last June, eliminating the constitutional right to terminate a pregnancy.
The lawsuit was brought by the legal group Alliance Defending Freedom on behalf of antiabortion medical organizations and four doctors who say they have treated patients with mifepristone. The complaint accuses the FDA of approving an “unsafe drug regimen” without sufficient study and objects to recent steps that make it easier to obtain the medication.
Public health professionals and legal experts have denounced the lawsuit as unsupported by scientific evidence. The FDA has repeatedly found the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions.
Justice Department lawyers object to the court potentially second-guessing the FDA’s technical expertise and have called the request for an injunction “extraordinary and unprecedented.” The lawsuit, the government said in court filings, is based on false claims that the drug inflicts severe complications and “fails to acknowledge that the alternatives to mifepristone — surgical abortion or continued pregnancy — also have rates of complications, with childbirth’s being substantially higher than mifepristone’s.”
In a two-step medication abortion, a patient first takes one mifepristone pill, which terminates the pregnancy. Approximately 24 hours later, they typically take a four-pill dose of misoprostol, a drug introduced in 1973 to treat stomach ulcers, to soften the cervix and prompt contractions that expel the embryo or fetus. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.
Without access to mifepristone, many providers say, they would continue to offer medication abortions using only misoprostol. Some would perform only surgical abortions. Providers said either scenario would result in massive upheaval as they try to enact new procedures, which some clinic owners fear may present legal hurdles. A few have been stockpiling mifepristone in anticipation of the ruling, hoping they would still be permitted to distribute the pills they already have regardless of Kacsmaryk’s decision.
Kacsmaryk, a nominee of President Donald Trump, has attracted criticism from abortion rights advocates because of his long-held antiabortion views. The scheduling of the hearing on Wednesday was also a source of controversy after the judge intentionally delayed public notice and asked lawyers for the parties to keep quiet about the planned hearing — actions he said he was taking to try to minimize disruptions, security threats and protests. Kacsmaryk said he might wait until late Tuesday to announce the hearing, which typically would have been posted on the court docket soon after the call.
After The Washington Post reported on the judge’s directive to lawyers, a coalition of media organizations criticized the decision, and the judge formally posted notice of the hearing on Monday.
This is a developing story. It will be updated.