AMARILLO, Texas (AP) — A federal judge in Texas raised questions Wednesday about a Christian group’s effort to overturn federal regulators’ decades-old 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 question of whether access to 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 alliance, which filed the case in Amarillo in anticipation of getting a favorable ruling.
“Explain to me why this court has that sweeping authority?” Kacsmaryk asked, in reference to the group’s request to pull mifepristone from the market.
The judge also questioned whether the group had the legal standing to obtain a pretrial ruling, 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 if the issue of standing had been clearly 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 disrupt reproductive care for women across the U.S.
“An injunction here would interfere with the interests of every state in the country” said Julie Harris of the U.S. Justice Department, which represented the FDA.
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 that none of the plaintiffs could show the type of harm typically needed for such a legal action.
One of the chief arguments leveled against the FDA in the lawsuit is that the agency misused its authority when it originally approved the abortion pill.
The FDA reviewed the drug 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.”
The FDA rejected the group’s argument on multiple accounts. First, attorneys said FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, government attorneys said the terms of mifepristone’s use were replaced more than a decade ago by subsequent FDA programs passed by Congress, rendering the argument irrelevant.
Finally, while the FDA reviewed the drug under its accelerated approval regime, it didn’t expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone.
Legal experts have long been deeply skeptical of many of the arguments made by the alliance. And there is essentially no precedent for a lone judge overruling an FDA drug approval decision.
At one point, Kacsmaryk asked the alliance’s attorneys about the possibility of suspending mifepristone’s approval, without withdrawing it completely.
“Any relief you grant must be complete” and apply nationwide, Baptist said. “The harms of these abortion drugs know no bounds.”
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 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 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.
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This story was updated to correct that the name of the plaintiff group is the Alliance Defending Freedom, not the Alliance for Defending Freedom.
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Perrone reported from Washington. Associated Press writer Jake Bleiberg in Dallas contributed to this report. Follow AP’s full coverage of abortion: https://apnews.com/hub/abortion.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Here is what’s at stake in abortion medication case
WASHINGTON (AP) — A federal judge heard arguments Wednesday in a lawsuit that poses a threat to the nationwide availability of a leading abortion medication. The hearing comes as a conservative Christian group seeks to reverse federal approval of the drug mifepristone.
A two-pill combination of mifepristone and another drug is the most common form of abortion in the U.S. and the ruling would affect states where abortion is legal as well as those that outlaw it. The case has raised concerns about court transparency and so-called judge shopping.
Here’s a look at some of the legal issues surrounding the case:
HOW DID THE ABORTION PILL CHALLENGE START?
Abortion opponents who helped overturn Roe v. Wade filed a lawsuit in November, asking a judge in Texas to reverse the approval of mifepristone.
Research shows that medication-induced abortions are safe and effective, and they were approved by the Food and Drug Administration more than 20 years ago.
But the group, Alliance Defending Freedom, argued in the lawsuit that the FDA process was flawed for mifepristone. It also took aim at more recent changes that have eased access to the drug.
The suit was filed in Amarillo, Texas, which meant that it was assigned to U.S. District Judge Matthew Kacsmaryk, a former attorney at a Christian law firm who previously wrote critically about Roe. He was appointed by former President Donald Trump and confirmed over fierce opposition from Democrats.
WHY IS IT IMPORTANT?
Medication is the most common form of abortion in the U.S., according to the Guttmacher Institute, a research group that supports abortion rights. It’s become more available as the FDA allowed it to be prescribed online and sent through the mail. Demand continued as states began banning abortion after Roe was overturned and more women traveled for access, or sought medication online.
If Kacsmaryk reverses the approval of mifepristone, it could restrict access nationwide. Such a ruling would be an unprecedented challenge to the FDA, which approved mifepristone in combination with a second pill, misoprostol, as a safe and effective method for ending a pregnancy in 2000.
That would be “nothing short of catastrophic,” a group of 22 Democratic-led states said in court documents filed in the case. Another group of 22 Republican states filed briefs supporting the reversal. They argue the ability to order pills by mail undermines their laws banning abortion.
WHY IS THIS IN THE HANDS OF ONE TEXAS JUDGE?
Kacsmaryk is a federal judge and one of the major tasks of the U.S. court system has always been deciding whether laws and policy are constitutional. That means any judge weighing a case challenging a federal law or policy could make a decision that has ripple effects across the nation.
Lawyers on either side of a case can appeal a ruling, however, and federal appeals courts can block or overturn a decision. In this case, an appeal would go to the 5th Circuit Court of Appeals, which also leans conservative. It upheld Kacsmaryk’s decision in another high-profile caserequiring the Biden administration to continue the “Remain in Mexico” immigration policy implemented by Trump. The ruling was later overturned by the Supreme Court.
The case has also raised concerns about judge shopping, a term for litigants seeking to file cases in front of judges they consider sympathetic to their cause. It’s a tactic that’s been utilized by groups across the ideological spectrum, but the volume of cases filed before Kacsmaryk and other Texas judges has raised concerns among experts.
WHAT SET OFF TRANSPARENCY ALARM BELLS?
Kacsmaryk set the first hearing in the closely watched case on a conference call with attorneys. He also asked them to for the “courtesy” of not publicizing the upcoming arguments, according to a court transcript.
He said he planned to delay making the hearing public until the evening before, making it difficult for many to attend because Amarillo is hours away from major cities. Such a delay is highly unusual in the American judicial system, where hearing notices are typically quickly made public and often scheduled weeks or months in advance.
After news reports about the call, the hearing was placed on the public docket a day and a half before it was scheduled.
WHAT HAPPENS NEXT?
A ruling in the case could come any time after the arguments conclude. A decision against the FDA would almost certainly be swiftly appealed by the Justice Department.
A ruling reversing approval 20 years later is all but unprecedented, so it’s not clear exactly what would happen next or how quickly access might be curtailed. If mifepristone is sidelined, clinics and doctors that prescribe the combination say they would switch to using only misoprostol, the other drug in the two-drug combination, an approach that is slightly less effective.