Abortion pill under threat in Texas lawsuit

AMARILLO, Texas -- A federal judge in Texas raised questions Wednesday about a Christian group's effort to overturn the decades-old U.S. approval of a leading abortion drug, in a case that could threaten the country's most common method for ending pregnancies.

Judge Matthew Kacsmaryk heard more than four hours of debate over the Alliance Defending Freedom's request to revoke or suspend the Food and Drug Administration's approval of mifepristone. Such a step would be an unprecedented challenge to the FDA and its authority in deciding which drugs to permit on the market.

Kacsmaryk said he would rule "as soon as possible," without giving any clear indication of how he might decide and leaving open the possibility that the standard regimen for medication abortions might soon be curtailed throughout the country.

Mifepristone, when combined with a second pill, was approved in 2000 and is used to end pregnancies until their 10th week. It has been increasingly prescribed since last summer's U.S. Supreme Court ruling overturning Roe v. Wade.

The Texas lawsuit has become the latest high-stakes legal battle over access to abortion since the question of its legality was returned to the states.

Kacsmaryk, who was appointed by former President Donald Trump, saved some of his most pointed questions for attorneys representing the conservative group, which filed its lawsuit in Amarillo in anticipation of receiving a favorable ruling.

"Explain to me why this court has that sweeping authority?" Kacsmaryk asked, in reference to the group's request for a preliminary order pulling mifepristone from the market.

The judge also questioned whether the group had the legal standing to obtain a pretrial ruling on the drug, grilling both sides on U.S. Supreme Court cases that set out when such extraordinary relief is allowed.

Still, the judge also posed questions suggesting he was considering how he might draft a preliminary injunction in the plaintiffs' favor, at one point asking the alliance's lawyers whether the issue of standing had been addressed by appellate courts. At another point, he told them their outline for the order of their arguments "tracks the elements for an injunction nicely."

Lawyers representing the FDA argued that pulling mifepristone would upend reproductive care for women across the U.S.

"An injunction here would interfere with the interests of every state in the country" said Julie Straus Harris of the U.S. Justice Department, which represented the FDA.

Straus Harris and her colleagues also questioned whether the alliance -- which filed its case on behalf of several anti-abortion doctors -- had standing to bring the lawsuit, given none of the plaintiffs could show the type of harm typically needed for such a legal action.

Kacsmaryk gave each side two hours to make their arguments -- with time for rebuttal -- in the high-stakes case. Mifepristone's manufacturer, Danco Laboratories, joined the FDA in arguing to keep the pill available.

A ruling could come at any time. A decision against the drug would be swiftly appealed by the Justice Department, which would also likely seek an emergency stay to stop it from taking effect while the case proceeds.

Members of the Women's March advocacy group rallied outside the courthouse, including one person dressed as a kangaroo to decry the proceedings as a "kangaroo court."

Ultimately, courthouse officials allowed 20 members of the media and 20 members of the general public to attend the hearing.

If Kacsmaryk rules against the FDA, it's unclear how quickly access to mifepristone could be curtailed or how the process would work. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberations, which can take months or years.

If mifepristone is sidelined, clinics and doctors that prescribe the combination say they would switch to using only misoprostol, the other drug used in the two-drug combination. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies but is widely used in countries where mifepristone is illegal or unavailable.

In addition to challenging mifepristone's approval process, the lawsuit takes aim at several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.