Texas judge halts FDA approval of abortion pill

Meanwhile, a Washington State federal judge issued a conflicting order Friday night that blocks the FDA from rolling back access to the pills in the dozen blue states that brought the lawsuit.

The ruling from U.S. District Court Judge Thomas O. Rice, an appointee of former President Barack Obama, clashes with Kacsmaryk’s in that it orders the FDA to maintain the status quo, raising the likelihood that the issue could go before the Supreme Court.

Kacsmaryk’s decision, for its part, is a sweeping endorsement of arguments brought by anti-abortion groups and disputed by the government and major medical groups that the FDA failed to adequately consider the safety risks of the pills.

Hitting back at arguments that it was inappropriate to allow a challenge to a medication that have been approved for decades, he also wrote that “the FDA stonewalled judicial review” and “ignored” petitions from anti-abortion organizations to revisit the pill’s approval.

The judge’s decision includes language commonly used by anti-abortion advocates, describing the intent of the pill as one “to kill the unborn human,” referring to abortion providers as “abortionists,” and describing the “intense psychological trauma” of people who use the pills and then see “the remains of their aborted children.”

Roughly a quarter of states have banned nearly all abortions in the eight months since Roe v. Wade was overturned but this decision has the potential to affect pregnant people across the country — including in Democratic-controlled states that have prioritized abortion access.

The pills, which the FDA approved for use in the first 10 weeks of pregnancy more than two decades ago, recently became the most common method of abortion in the United States, and a way many people have circumvented state bans since the Supreme Court overturned Roe v. Wade last June.

Both abortion-rights supporters and opponents have focused intensely on the pills in recent months — leading to clashes in state legislatures, regulatory agencies and the courts.

‘A dangerous precedent’

The Justice Department quickly appealed the case to the right-leaning 5th U.S. Circuit Court of Appeals Friday night, and top members of the Biden administration said that defending the FDA’s authority and maintaining access to the pills is a top priority.

“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,” President Joe Biden said in a statement Friday night, referencing widespread concerns among medical providers that the decision would spur other legal challenges to long-approved medications, including vaccines and contraception. “My Administration will fight this ruling.”

Attorney General Merrick Garland also weighed in Friday evening, saying that while the Justice Department “strongly disagrees” with the Texas decision and is appealing it, the DOJ is still reviewing the Washington State ruling. In both cases, he stressed, the administration “is committed to protecting Americans’ access to legal reproductive care.”

The anti-abortion groups that brought the challenge, meanwhile, cheered Kacsmaryk’s ruling Friday night, calling it a “significant victory” and insisting on a call with reporters that if higher courts don’t intervene over the next week, the two pharmaceutical companies that make the pills “should cease production of this drug.”

Erik Baptist, a senior counsel with the Alliance Defending Freedom, who argued the case in Texas on behalf of anti-abortion medical groups, declined to comment on the ruling out of Washington State that protects access to the drugs, but said the issue “may be inevitably going to the Supreme Court.”

Baptist also pushed back on accusations that his organization engaged in “judge shopping” by filing the case where the group knew it would come before Kacsmaryk who — before being confirmed to the federal bench in 2019 — was an attorney for the First Liberty Institute, a conservative Christian legal advocacy group. He argued that some of the doctors he represented in the case are based in Amarillo, Texas, and have recently been impacted by the pills by having to divert resources to patients who took them and needed follow-up care.

At oral arguments in the case in March, the anti-abortion medical groups and individual doctors Baptist represented claimed that the FDA erred in its approval of the drug and didn’t adequately consider its safety risks — a position Kacsmaryk cited in his ruling.

“The adverse events from chemical abortion drugs can overwhelm the medical system and consume crucial limited medical resources, including blood for transfusions, physician time and attention, space in hospitals and medical centers, and other equipment and medicines,” the American Association of Pro-Life Obstetricians & Gynecologists, Christian Medical & Dental Associations and other organizations claimed in their suit. “The more patients suffering emergency complications from chemical abortion drugs or seeking to reverse the effects of the drug regimen, the less time and attention Plaintiff doctors have to treat their other patients.”

The Justice Department asked Kacsmaryk to dismiss the case, saying the doctors and medical groups have no standing and are attempting to “upend [the FDA’s] longstanding scientific determination based on speculative allegations of harm.” The DOJ also argued that the groups are well past the statute of limitations for challenging the 2000 approval of the pills, saying they can only legally go after the more recent agency actions that have loosened restrictions on how patients obtain them.

The 2021 and 2023 rule changes that allowed patients with a prescription to receive the pills by mail and pick them up at retail pharmacies were based on “multiple studies that showed that administration of the drug was associated with exceedingly low rates of serious adverse events,” DOJ argued to the court. The FDA first allowed telemedicine prescription of the pills just for the duration of the Covid-19 pandemic and later moved to make the rules permanent based on new safety data.

Danco, the maker of the drug, has also intervened as a party in the case, arguing that the suit threatens “the company’s economic health.” The company said it would immediately appeal the ruling, calling it “a dark day for public health.”

Democratic state attorneys general joined forces with the Biden administration in the Texas case but a dozen of them faced off with government lawyers for the FDA in the Washington State case, arguing that the remaining federal restrictions on the pills are unsupported by science and hamper states’ ability to care for patients who need the medication.

Washington’s Bob Ferguson and Oregon’s Ellen Rosenblum co-led the lawsuit, joined by the Democratic attorneys general representing Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.

Judge Rice has not yet ruled on their challenge of the REMS — or Risk Evaluation & Mitigation Strategies — that the FDA places on a narrow class of drugs, including requirements that patients sign a “Patient Agreement Form” acknowledging the risks of the medication and that health care providers who prescribe the drug first obtain certification and prove they can accurately date pregnancies, diagnose ectopic pregnancies and provide or arrange for a follow-up care if needed.

Potential impact of Texas ruling

If the ban ordered by Kacsmaryk ultimately takes effect, some parts of the country could be hit particularly hard. An analysis by the Guttmacher Institute, an abortion-rights think tank, found that abortion clinics in 2 percent of U.S. counties only offer abortion pills and don’t have a procedural option. Some of the states set to be most impacted — including Colorado, Pennsylvania and New Mexico — are serving their own residents and a large influx of patients from neighboring states with more restrictions. Guttmacher estimates the decision could impede access for at least 2.4 million people.

Some abortion providers have announced that they plan to pivot to prescribing just the second pill in the two-pill regimen — misoprostol — in the event that mifepristone is banned. The drug is subject to fewer restrictions because it’s used for many non-abortion purposes, including treating stomach ulcers. Misoprostol-only abortions are also common in other countries, but they have a slightly higher rate of patients requiring follow-up surgery to complete the abortion than the two pills used together.

“We’ve been preparing for the last few weeks, putting together updated policies and procedures that will go into effect should the ruling make mifepristone unavailable,” Ashley Brink, the director of the Trust Women abortion clinic in Wichita, Kansas, told reporters in February. “We’ve held trainings for our doctors on how to counsel patients on what to expect and we’ve met with our attorneys about our legal exposure.”

“However,” she stressed, “not every clinic may be able to pivot as quickly to a misoprostol-only protocol.”

If the decision banning mifepristone is allowed to stand, the FDA could move to approve it again if it receives a new application from the pharmaceutical company — a process that could take months if not years.

Abortion-rights advocacy groups also warn the decision could open the door to a wide range of ideologically motivated challenges to anything from birth control to vaccines.

“It basically puts at risk people’s access to medication that they rely on,” Carrie Flaxman, an attorney for Planned Parenthood, said in an interview. “This would allow anyone to come back decades later and claim a medication is unsafe.”

Josh Gerstein contributed to this report.