The status of a key abortion medication was cast into uncertainty Friday night when rulings from two federal judges reached contradictory conclusions, with one jurist blocking U.S. government approval of the drug while the other said the pill should remain available in a swath of states.
The highly anticipated and unprecedented ruling from Texas puts on hold the Food and Drug Administration’s approval of mifepristone, which was cleared for use in the United States in 2000. It was the first time a judge suspended longtime FDA approval of a medication despite opposition from the agency and the drug’s manufacturer. The ruling will not go into effect for seven days to give the government time to appeal.
U.S. District Judge Matthew J. Kacsmaryk, a nominee of President Donald Trump with long-held antiabortion views, agreed with the conservative groups seeking to reverse the FDA’s approval of mifepristone as safe and effective, including in states where abortion rights are protected.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the 67-page opinion. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” He added that the agency had faced “significant political pressure” to “increase ‘access’ to chemical abortion.”
In a competing opinion late Friday, a federal judge in Washington state ruled in a separate case involving mifepristone that the drug is safe and effective. U.S. District Judge Thomas O. Rice, who was nominated by President Barack Obama, ordered the FDA to preserve “the status quo” and retain access in the 17 states — along with D.C. — that are behind the second lawsuit, which seeks to protect medication abortion.
Within hours of the Texas ruling, the Justice Department and drug manufacturer Danco Laboratories filed their notice of appeal. Attorney General Merrick Garland said the government would ask the U.S. Court of Appeals for the 5th Circuit to allow the FDA to maintain approval of the pill pending the outcome of the case. Garland said in a statement that the department was still reviewing the decision out of Washington state.
President Biden criticized the Texas ruling in a statement Friday, saying the court had “substituted its judgment for FDA, the expert agency that approves drugs. If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
He called the decision “another unprecedented step in taking away basic freedoms from women and putting their health at risk.”
The conflicting and complicated decisions will likely put pressure on the FDA and the Biden administration to determine how to enforce the new mandates set by these rulings.
The judge’s decision in Texas to pause his own ruling for a week while the administration seeks review in the 5th Circuit, and the contrary ruling in Washington state, means no immediate change in the status quo. But the Biden administration might not want to wait for the 5th Circuit to act before bringing the issue to the Supreme Court.
It could ask the justices to put Kacsmaryk’s decision on hold while legal battles continue. The justices might then face a decision about whether to hear the case in the normal course of business — which would mean scheduling a hearing in the new term that begins in October — or to take up the case on an emergency basis.
The court has done that in some recent cases. But that could cause serious problems for a court that has one round of oral arguments left in the current term, and has issued few opinions in cases already argued and none in the biggest disputes involving election law, affirmative action and religious and LGBTQ rights.
Medication-induced abortion has become increasingly contentious since the high court overturned the nearly 50-year-old Roe v. Wade decision last June, which allowed states to outlaw or sharply restrict the procedure.
Abortion clinics reached Friday night emphasized that the Texas ruling would not affect their care for the next seven days. Even then, if Kacsmaryk’s ruling takes effect, several providers said they would not stop prescribing mifepristone until they are instructed to do so by the FDA.
Many abortion clinics have been preparing for the Texas ruling for months. If they are forced to stop providing mifepristone, they say, they will continue to provide surgical abortions and, in many cases, a different medication abortion regimen that includes only misoprostol, the second drug in the standard two-step medication abortion regimen.
“Nothing changes for us tomorrow,” Amy Hagstrom Miller, chief executive of Whole Woman’s Health, a network of abortion clinics, texted a group of her staff at 6:51 p.m., less than an hour after the ruling was issued.
Whole Woman’s Health will not stop prescribing mifepristone until it receives directions from the FDA, Hagstrom Miller said.
The Texas lawsuit was brought by the legal group Alliance Defending Freedom on behalf of antiabortion medical organizations and four doctors who say they have treated patients with mifepristone. It claimed the FDA did not have the power to approve the drug and takes issue with the agency’s easing of restrictions on the pill through the years.
In a statement Friday, the group’s senior counsel, Erik Baptist, said the FDA “never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”
Public health professionals and legal experts had denounced the lawsuit as unsupported by scientific evidence. The FDA has repeatedly found the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions. The drug manufacturer, Danco, and the Justice Department have called the plaintiff’s claims baseless.
In response to the ruling, Abby Long, Danco’s director of public affairs, said in a statement, “This is a dark day for public health, especially reproductive rights and the reliance on science and medical expertise to guide decisions about what drugs are safe and effective and should be available to patients.” The court’s ruling, she said, “fails to account for the meticulous, well-documented FDA decision-making process.”
In his ruling, Kacsmaryk was highly critical of the FDA’s decisions over the years to loosen restrictions on how the pill is administered and faulted the FDA for “lax reporting requirements.”
The FDA, he wrote, “took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls.”
He found that suspending approval was in the public interest because of the drug’s potential side effects.
“Many women also experience intense psychological trauma and post-traumatic stress from excessive bleeding and from seeing the remains of their aborted children,” he wrote.
Throughout the ruling, Kacsmaryk used language often invoked by the antiabortion movement, referring to abortion providers as “abortionists” and characterizing mifepristone as being used “to kill the unborn human.” Kacsmaryk, a conservative Christian with a long history of antiabortion views, issued the ruling on Good Friday.
Nathan Cortez, a law professor and FDA scholar at Southern Methodist University, said the judge’s ruling was “about as out-there as you can imagine.”
“The sources he cites and the terminology he uses also read very much like the opinion of an antiabortion crusader rather than an impartial judge,” said Cortez, who was one of 19 FDA experts who signed onto an amicus brief supporting the agency’s position that the pill had been properly approved.
“It cannot be overstated that courts just don’t override FDA’s judgment on whether to approve new drugs and what conditions to place on their marketing — and for good reason: again, most judges know these are incredibly complex decisions.”
Both sides made their cases to Kacsmaryk on March 15 during a four-hour hearing that focused on the technical aspects of federal drug regulation and FDA processes. Kacsmaryk seemed aware of the stakes and how historic this case could be, asking the lawyers about legal precedent and his authority to essentially override the FDA’s approval of a drug more than 20 years ago.
The lawsuit in Washington state was filed in February — three months after the challenge to mifepristone was filed in Texas. Washington Attorney General Bob Ferguson said the FDA imposed too many restrictions on mifepristone and asked the judge to order the federal government to make the medication easier for people to obtain.
While these legal proceedings are entirely separate from the one in Kacsmaryk’s Texas courtroom, it appears to serve as at least a partial rebuke to that lawsuit. In a February news release announcing his lawsuit, Ferguson noted that Washington was one of 21 states along with D.C. to file a brief in the Texas abortion pill case, urging Kascmaryk to allow the FDA to maintain its approval of the abortion pill. Ultimately, Rice did not order the FDA to roll back any of its restrictions of mifepristone in his Friday ruling, but he ruled that the status quo must remain.
In a two-step medication abortion, a patient first takes one mifepristone pill, which terminates the pregnancy. About 24 hours later, the patient typically takes a four-pill dose of misoprostol — a drug introduced in 1973 to treat stomach ulcers — to soften the cervix and prompt contractions that expel the embryo or fetus. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.
The Texas lawsuit targeted the FDA’s loosening of restrictions on the abortion pill, including the agency’s decision in 2016 to say the drug could be used through 10 weeks of pregnancy, up from the seven-week limit in the initial approval. The FDA took steps this year to ease access to the medication in states where its use is legal, allowing retail pharmacies to dispense the pills directly from doctors or by mail.
Abortion providers expressed concern Friday that Kacsmaryk’s ruling could curtail their ability to send abortion pills — both mifepristone and misoprostol — through the mail. Many patients rely on telehealth services that mail pills, especially those living in rural areas, far from brick-and-mortar clinics.
In his ruling, Kacsmaryk repeatedly invoked the Comstock Act, a 150-year-old law that prohibits mailing any drug used “for producing abortion,” which has not been applied for decades. Arguments that the Comstock Act no longer applies are “unpersuasive,” Kacsmaryk wrote, adding that federal criminal law declares abortion pills “nonmailable.”
David Ovalle and Tyler Pager contributed to this report.
