Since last summer’s U.S. Supreme Court ruling overturning Roe v. Wade, Mifepristone, in combination with another drug, has been the method of choice to end unwanted pregnancies until the 10th week.
The abortion drug was approved by the FDA in 2000, but now this method of birth control is coming under fire in Texas, where a Christian group is making efforts to overturn the decades-old U.S. approval. The case is crucial as it could threaten the country’s most common method for ending pregnancies in the wake of the tightened restrictions on abortion.
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. In addition to the consequences on women seeking an abortion, 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 come to an end throughout the country.
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, addressed some of his most pointed questions for attorneys representing the conservative group, which filed its lawsuit in Amarillo and was confident 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.
Despite the challenge to the conservative group’s request, 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 if the issue of standing had been addressed by appellate courts. At another point, he told them that 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.
One of the chief arguments leveled against the FDA in the case is that the agency misused its authority when it originally approved mifepristone.
The FDA reviewed the pill under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it has been used to expedite drugs for cancer and other “serious or life-threatening diseases.”
“The plain text is clear it applies to illnesses,” argued Erik Baptist, the alliance’s lead attorney. “Mifepristone is used to end pregnancies, and pregnancy isn’t an illness.”
Sharply questioning both sides, the judge gave no hint as to which way he would rule.
