Federal judge in Texas suspends FDA approval of abortion pill

Mifeprex, the brand name for mifepristone, is a drug that is used to end an early pregnancy, seen here at Alamo Women’s Reproductive Services in San Antonio on June 14, 2022. (Credit: Kylie Cooper/The Texas Tribune)

In a potentially devastating blow for abortion access nationwide, a federal judge in Amarillo has suspended the approval of mifepristone, an abortion-inducing drug that has been on the market for more than 20 years.

U.S. District Judge Matthew Kacsmaryk’s ruling will go into effect in seven days, to allow the U.S. Food and Drug Administration time to appeal the decision.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the ruling. “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.”

Kacsmaryk wrote that the FDA succumbed to political pressure when it approved mifepristone more than 20 years ago and subsequently lifted restrictions on the medication over the ensuing two decades, arguing that “the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions.”

Medication abortion is the most common way Americans terminate their pregnancies. Mifepristone, when taken alongside misoprostol, has been proven to be safe and effective and is recommended by the American College of Obstetricians and Gynecologists and the World Health Organization.

“This is the first time a judge has unilaterally, against the FDA’s objections, removed a drug from the market,” said Greer Donley, a University of Pittsburgh law professor who studies FDA law. “A judge who has ... no scientific expertise, overruling the agency that has a ton of scientific expertise.”

Kacsmaryk has deep ties to the anti-abortion movement, and the language in the 67-page ruling, released at 5:30 p.m. Friday, reflects those ties — calling abortion providers “abortionists” and describing the use of mifepristone as killing or “starv[ing] the unborn human until death.”

Kacsmaryk also resurfaced an 1800s law that prohibits the mailing of anything related to an abortion, which could have much wider effects than this one lawsuit.

“It is indisputable that chemical abortion drugs are both ‘drug[s]’ and are ‘for producing abortion,’ Kacsmaryk wrote. “Therefore, federal criminal law declares they are ‘nonmailable.’”

Almost simultaneously, a federal judge in Washington issued a potentially conflicting ruling that blocks the FDA from “altering the status quo ... as it relates to Mifepristone.” This federal court conflict will likely move the dispute before the U.S. Supreme Court before long.

This ruling will not change the legality of abortion in Texas, where the procedure has been virtually banned since the overturning of Roe v. Wade in late June. But it will further limit out-of-state options and may have ripple effects for those who seek the medication illicitly.

Erik Baptist, senior counsel for the Alliance Defending Freedom, the conservative law firm that brought the lawsuit, called Friday’s ruling a “significant victory.”

“The FDA put women and girls in harm’s way and it’s high time the agency is held accountable for its reckless actions,” he said. “The FDA never had the authority to approve these hazardous drugs and remove important safeguards.”

Mifepristone’s approval

Almost since the FDA approved mifepristone in 2000, anti-abortion groups have been working to reverse that decision.

In 2002, they filed a citizen petition, asking the agency to review the decision. The FDA did not respond to that petition until 2016, rejecting it on the same day that the agency relaxed restrictions on the medication, citing its safety, efficacy and minuscule rate of adverse incidents.

The new regulations increased the period of gestation at which the drug could safely be used, from seven weeks of pregnancy to 10 weeks. It also decreased the recommended dosage and reduced the number of required doctor visits.

In 2019, the FDA approved a generic version of mifepristone, and then in January, after easing some requirements during the pandemic, the FDA permanently lifted the in-person dispensing requirement, allowing the medication to be prescribed through telehealth appointments, dispensed at retail pharmacies and sent through the mail.

None of this trumps state law; in Texas, nearly all abortion, including medication abortion, is prohibited. In 2021, legislators passed a law specifically making it a felony to mail abortion-inducing medication.

This lawsuit, filed by the ADF in November, is the latest attempt to move mifepristone off the market. The ADF is representing a group of anti-abortion doctors and medical associations who say they have been harmed by having to treat complications from abortion-inducing medication.

In a March hearing in Amarillo, ADF attorney Erin Morrow Hawley argued that allowing abortion medication to remain on the market was an “affront to the states,” in that it denied states that had banned abortion the ability to “protect the health and welfare of women and children within their boundaries.”

Lawyers for the Department of Justice, which is representing the FDA, countered that approving a drug is not tantamount to requiring anyone to prescribe it.

“The agency did not obligate or require anyone to prescribe or take mifepristone,” said Julie Straus Harris. “It simply said, we are giving it our grant … that it is safe and effective.”

The plaintiffs claim mifepristone was improperly classified as a drug used “in treating serious or life-threatening illnesses” to “provide meaningful therapeutic benefit to patients over existing treatments.”

“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” their lawsuit reads. “In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”

Congress later moved that designation — called “subpart H” in FDA parlance — into a new category, which allows drugs to be approved to treat conditions, as well as illness.

“This is really just kind of trying to exploit a technicality in the language that isn’t even relevant anymore,” Donley said. “Pregnancy, of course, can cause serious and life-threatening conditions … It’s not like pregnancy is risk-free — far from it.”

But Kacsmaryk rejected the FDA’s arguments, ruling that medication abortion “reflect little or no benefit over surgical abortion — much less a ‘meaningful therapeutic’ benefit.”

Legal experts and the FDA have identified several crucial issues with the lawsuit, from misstated science, to a long-expired statute of limitations, to a lack of standing.

To have “standing” to challenge a law, policy or action, at least one plaintiff must be able to demonstrate they have been harmed. The plaintiffs claim that the doctors in their suit have been harmed by having to treat patients who have experienced adverse effects from taking mifepristone.

“What the FDA has done, in illegally approving and then continually deregulating mifepristone, has resulted in doctors being forced, contrary to their most deeply held ethical, medical and religious convictions, to participate and finish elective abortions,” Hawley said.

Kacsmaryk agreed with the Alliance Defending Freedom, writing in his ruling that the “adverse events from chemical abortion drugs can overwhelm the medical system,” and thus, they have associational and organizational standing to bring this suit.

This is a “pretty wispy” standing argument, said David Coale, a Dallas appellate attorney.

“It’s going to have a hard time if it goes up on standing issues before the 5th [U.S. Circuit Court of Appeals],” Coale said. “There are judges who are certainly receptive to the plaintiff’s criticism of the FDA and where the plaintiffs are going, but standing is a serious matter for judicial conservatives.”

But Kacsmaryk is an outlier. He has shown a willingness to ignore the standing issue before, including in a challenge to the federal Title X program, which provides confidential contraception. The suit was brought by a father whose daughters had never been to a Title X clinic, but Kacsmaryk nonetheless ruled that the program violated Texas law and parents’ rights.

What comes next

Kacsmaryk’s long-awaited ruling was almost immediately overshadowed by the ruling from Washington state, which directs the FDA to not change anything about its current approval of mifepristone. It will likely be up to the U.S. Supreme Court to resolve these diametrically opposed rulings; the high courts can step in as soon as the cases are appealed, if it chooses to. But in the meantime, Kacsmaryk’s ruling stands.

If the 5th U.S. Circuit Court of Appeals — or the U.S. Supreme Court — doesn’t act within the seven-day window Kacsmaryk granted the defendants, mifepristone will become an unapproved drug, Donley said.

“The FDA can use their enforcement discretion and say, even though the drug is unapproved, we’re not going to go after anyone for selling, manufacturing or dispensing this unapproved drug,” she said. “But unless the 5th Circuit changes something, in seven days, this will become an unapproved drug.”

Abortion providers and even some states have been stockpiling mifepristone in the lead up to this ruling. Some clinics are preparing to use misoprostol alone, which has a lower efficacy rate and greater likelihood of side effects.

“Today’s decision is clearly a transparent effort to make it harder for people to access medication abortion,” the American College of Obstetrics and Gynecology said in a statement. “It will force people to turn to other means of accessing abortion care; it will force clinicians to prescribe less safe, less effective regimens for medication abortion; and it will impose greater harm on those who already struggle to access needed reproductive health care, thus increasing health inequities.”