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Texas judge seems open to claim abortion drug was not properly vetted

U.S. Judge Matthew Kacsmaryk says he will rule as soon as possible on FDA approval of mifepristone, one of two drugs used in medical abortions

A Homeland Security Officer secures the scene outside the federal courthouse in Amarillo, Tex., on March 15. Judge Matthew Kacsmaryk is expected to hear arguments in a lawsuit that takes aim at medication abortions. (David Erickson/AP)
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AMARILLO, Tex. — The federal judge who could upend access to a key abortion medication seemed open on Wednesday to the argument that the drug had not been properly vetted and could be unsafe — claims the Food and Drug Administration and leading health organizations strongly contest.

While the antiabortion group challenging the drug acknowledged there is no precedent for a court to order the suspension of a long-approved medication, U.S. District Judge Matthew Kacsmaryk questioned whether mifepristone has met the rigorous federal standard necessary to be prescribed to patients in the United States.

He asked a lawyer for the group whether the court could unilaterally withdraw FDA approval for a drug, and engaged with attorneys for both sides about whether mailing the pills should be prohibited because of a 19th-century law that bans sending articles “for any indecent or immoral use” through the Postal Service.

At the close of the four-hour hearing, Kacsmaryk said he would issue his ruling as soon as possible, potentially disrupting access to mifepristone even in states where abortion is legal and protected. His decision will likely be appealed to the conservative U.S. Court of Appeals for the 5th Circuit and the case could eventually reach the Supreme Court.

Medication-induced abortion, which accounts for more than half of all abortions in the United States, has become increasingly contentious since the Supreme Court’s conservative majority overturned Roe v. Wade in June, eliminating the constitutional right to terminate a pregnancy.

In a two-step medication abortion, a patient first takes one mifepristone pill, which terminates the pregnancy, then takes a second drug, misoprostol, to expel the embryo or fetus. While misoprostol is widely used on its own to perform abortions around the world — and many U.S. abortion providers say they will do the same if mifepristone is taken off the market — studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.

The abortion pill is actually two pills — mifepristone and misoprostol. Here’s how it works. (Video: The Washington Post)

The lawsuit was brought by the conservative 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 and said it could upend the FDA’s overall drug approval process. The agency has repeatedly found the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions.

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

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.”

A Texas judge held a hearing March 15 in a lawsuit brought by anti-abortion groups, challenging the FDA approval of the widely used abortion pill mifepristone (Video: The Washington Post)

Wednesday’s hearing was the first time Kacsmaryk engaged 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.

The judge reserved his toughest questions for the government’s lawyers. He expressed skepticism about what he characterized as an accelerated government process for approving mifepristone, and questioned the safety of a more recent FDA decision allowing the medication to be dispensed by mail instead of being given in-person by a doctor. Kacsmaryk noted that the accelerated process is typically used for drugs that treat life-threatening illnesses such as HIV and cancer. In response, Justice Department lawyers pushed back against allegations that the approval process was flawed and said there is tremendous evidence showing the pill is safe — even when a doctor does not administer it.

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

Kacsmaryk pressed Erik Baptist, a lawyer with Alliance Defending Freedom, about whether he could come up with an “analogue where courts have intervened in such a way” so many years after a drug has been approved.

“No, I can’t,” Baptist said. He then noted that individuals spent years trying to challenge the drug’s approval internally through the FDA.

Kacsmaryk also solicited guidance from Baptist on how a potential ruling might play out, asking whether the conservative group believes a judge may unilaterally direct the FDA to withdraw its approval, or only has the power to begin that process.

The court may “on its own accord” order the FDA withdrawal, Baptist said.

Kacsmaryk could issue a broad ruling, ordering the government to withdraw approval of the drug, or issue a more limited decision — for example, requiring the FDA to reimpose restrictions on how mifepristone is distributed.

It is unusual for the FDA to order a drug off the market for safety reasons. The multistep process can take years, because the manufacturer, if it disagrees with the agency, is entitled to present its case and can request a hearing.

At the hearing, Kacsmaryk also questioned whether the antiabortion groups and individual doctors challenging the drug have sufficient legal grounds or standing to proceed with their lawsuit. The Justice Department has characterized as speculative the doctors’ claims that they have been directly harmed because they have treated patients who claimed to suffer complications from the medication.

Much of Wednesday’s hearing focused on federal regulations and FDA processes. It did not delve into the legality of abortion or when life begins.

During the hearing, lawyers for the antiabortion group argued that the FDA’s decision to allow abortion pills to be distributed by mail violates a 150-year-old law. The Comstock Act, they say, prohibits mailing any drug used “for producing abortion.”

Those arguments appeared to resonate with Kacsmaryk, who asked government lawyers if there was “any dispute” that the law prohibits mailing abortion medication.

The Justice Department argued that the modern-day reading of the law has never prevented the mailing of abortion pills, in part because the medications have other uses and because abortion remains legal in many circumstances.

A few minutes before the hearing adjourned, Kacsmaryk sought confirmation that the plaintiffs were not also challenging FDA approval of misoprostol.

“Correct,” said Baptist, adding that misoprostol has a number of approved uses other than abortion. At the same time, he argued that a decision that relies on the Comstock Act could impact misoprostol as well.

Jenny Ma, senior counsel for the Center for Reproductive Rights, said in a recent interview that if Kacsmaryk invokes the law in his ruling, he could prohibit the mailing of all forms of medication abortion, including both the two-step regimen with mifepristone and the misoprostol-only alternative.

Even if access to misoprostol is unaffected, some providers say they would perform only surgical abortions if mifepristone is taken off the market. 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. Organizations that ship abortion medication to customers in the U.S. from overseas would not be directly impacted by the judge’s ruling.

Kacsmaryk, a nominee of President Donald Trump, has attracted criticism from abortion rights advocates because of his long-held antiabortion views. He was previously a lawyer for the conservative legal organization First Liberty.

A devout Christian, Kacsmaryk typically begins proceedings in his courtroom by having a clerk say, “Let us pray.” Wednesday’s hearing opened that way as well.

The scheduling of the hearing itself was 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.

Marimow reported from Washington. Laurie McGinley in Washington contributed to this report.

Abortion access in America

Tracking abortion access in the U.S.: After the Supreme Court struck down Roe v. Wade, the legality of abortion is left to individual states. The Post is tracking states where abortion is legal, banned or under threat.

Abortion pills: The Justice Department appealed a Texas judge’s decision that would block approval of the abortion pill mifepristone. The Supreme Court decided to retain full access to mifepristone as the appeal proceeds. Here’s an explanation of what happens next in the abortion pill case.

Post-Roe America: With Roe overturned, women who had secret abortions before Roe v. Wade felt compelled to speak out. Other women who were seeking abortions while living in states with strict abortion bans also shared their experiences with The Post through calls, text messages and other documentation. Here are photos and stories from across America since the reversal of Roe v. Wade.