He asked the group’s lawyer if the court could unilaterally revoke the FDA’s approval for the drug, and contacted attorneys for both sides about whether the pills should be banned from mailing due to 19th century law which prohibits the submission of articles “for any obscene or immoral use” through the Postal Service.

At the end of the four-hour hearing, Kaczmarik said he would make his decision as soon as possible, which could lead to disruption of access to mifepristone even in states where abortion is legal and protected by law. His decision is likely to be appealed to the conservative US Court of Appeals for the Fifth Circuit, and the case could eventually go to the Supreme Court.

Medical abortion, which accounts for more than half of all abortions in the United States, has become increasingly controversial since the Supreme Court’s conservative majority rejected it. Row vs Calf in June, abolishing the constitutional right to terminate a pregnancy.

In a two-stage medical abortion, the patient first takes one tablet of mifepristone, which terminates the pregnancy, then takes a second drug, misoprostol, to expel the embryo or fetus. While misoprostol is widely used by itself for abortions around the world – and many U.S. abortion providers say they will do the same if mifepristone is withdrawn from sale – studies show it is less effective than the two-step regimen. , and usually causes more cramping and bleeding.

The lawsuit was filed by the conservative legal group, the Alliance for Freedom, on behalf of anti-abortion medical organizations and four doctors who claim to have treated patients with mifepristone. The complaint accuses the FDA of approving an “unsafe drug regimen” without sufficient scrutiny and objects to recent moves to make it easier to get the drug.

Public health professionals and lawyers condemned the lawsuit as unsupported by scientific evidence and said it could overturn the FDA’s overall drug approval process. The agency has repeatedly stated that the two-stage medical abortion protocol is a safe and effective alternative to surgical abortion.

The plaintiffs have asked Kaczmarik to issue a preliminary injunction ordering the FDA to withdraw or suspend its approval of mifepristone.

Justice Department lawyers object to the court’s questioning the FDA’s technical expertise and called the request for an injunction “extraordinary and unprecedented.” The lawsuit, the government said in court documents, is based on false claims that the drug causes serious complications and “does not recognize that the alternatives to mifepristone – surgical abortion or pregnancy maintenance – also have a complication rate, with birth rates significantly higher than mifepristone”.

Wednesday’s hearing was the first time Kaczmarik spoke directly with DOJ lawyers representing the FDA; the company that manufactures and distributes the drug; and an anti-abortion group challenging the drug.

The judge left his toughest questions to state attorneys. He expressed skepticism about what he described as an accelerated government approval process for mifepristone and questioned the safety of a more recent FDA decision to allow the drug to be dispensed by mail rather than in person by a doctor. Kaczmarik noted that the accelerated process is commonly used for drugs that treat life-threatening diseases such as HIV and cancer. In response, Justice Department lawyers opposed accusations that the approval process was flawed and said there was strong evidence that the pill was safe even if it was not administered by a doctor.

It took more than four years for the abortion pill to receive FDA approval in 2000.

Kaczmarik approached Eric Baptist, a lawyer at Alliance Defending Freedom, asking if he could come up with a “counterpart where the courts intervene in this way” so many years after the drug was approved.

“No, I can’t,” Baptiste said. He then noted that people had been trying for years to challenge the approval of the drug internally through the FDA.

Kaczmarik also reached out to Baptist for advice on how a potential solution could be implemented, asking if the conservative group thinks a judge can unilaterally direct the FDA to withdraw its approval or has the power to just start the process.

According to Baptiste, the court may “at its own discretion” order the FDA to withdraw.

Kaczmarik could issue a broad ruling directing the government to withdraw approval of the drug, or a narrower resolution, such as requiring the FDA to reintroduce restrictions on the distribution of mifepristone.

It is unusual for the FDA to order a drug from the market for safety reasons. The multi-step process can take years because the manufacturer, if they disagree with the agency, has the right to present their case and can request a hearing.

At the hearing, Kaczmarik also questioned whether anti-abortion groups and individual doctors challenging the drug have sufficient legal grounds or standing to file a lawsuit. The Department of Justice described as speculative doctors’ claims that they were directly harmed because they treated patients who claimed they had complications from their medications.

Much of Wednesday’s hearing focused on federal regulations and FDA processes. He didn’t delve into the legality of abortion or when life begins.

During the hearing, lawyers for the anti-abortion group argued that the FDA’s decision to allow mail-order abortion pills violated a 150-year-old law. The Comstock Act, they say, prohibits the mailing of any drugs used “to produce abortions.”

These arguments seem to have resonated with Kaczmarik, who asked government lawyers if there was “any dispute” that the law prohibits mail-order abortion drugs.

The Justice Department argued that modern interpretation of the law has never prevented abortion pills from being mailed, partly because the drugs have other uses and because abortion remains legal in many cases.

Minutes before the adjournment of the hearing, Kaczmarik requested confirmation that the plaintiffs also did not contest the FDA’s approval of misoprostol.

“Right,” Baptiste said, adding that misoprostol has a number of approved uses beyond abortion. At the same time, he argued that a decision based on Comstock’s Law may also affect misoprostol.

Jenny Ma, senior adviser for the Center for Reproductive Rights, said in a recent interview that if Kaczmarik invokes the law in his decision, he could ban all forms of medical abortion by mail, including the two-stage regimen with mifepristone and the misoprostol-only alternative.

Even if access to misoprostol is not restricted, some providers say they will only do surgical abortions if mifepristone is taken off the market. Service providers said either scenario would lead to widespread upheaval as they attempt to introduce new procedures that some clinic owners fear could create legal hurdles.

Some stockpiled mifepristone pending a decision, hoping that they would still be allowed to distribute the pills they already have, regardless of Kaczmarik’s decision. Organizations that ship abortion drugs to clients in the US from overseas will not be directly affected by the judge’s decision.

Kachmarik, candidate for President Donald Trump draws criticism from abortion rights advocates due to his longtime anti-abortion views. Previously, he was a lawyer for the conservative legal organization First Liberty.

A devout Christian, Kaczmarik usually begins a trial in the courtroom by saying: “Let’s pray.” Wednesday’s hearing also opened in this way.

The scheduling of the hearing itself became a source of controversy after the judge deliberately delayed public notice and asked the parties’ lawyers to remain silent about the scheduled hearing, steps he said he took to try to minimize disruptions, security threats and protests. Kaczmarik said he could wait until late Tuesday to announce the hearing, which would normally be published in court records shortly after the call.

After The Washington Post informed lawyers of the judge’s directive, a coalition of media organizations criticized the decision, and on Monday the judge officially released a notice of the hearing.

Marimov reported from Washington. Laurie McGinley of Washington contributed to this report.