Nation/World

Abortion providers grapple with conflicting rulings on a key abortion pill

Shortly after a key abortion pill was thrust into legal uncertainty, Melissa Grant fired off an email to her staff: “It is business as usual for us for at least the next 7 days.”

U.S. District Judge Matthew J. Kacsmaryk in Texas had just blocked the federal government’s decades-old approval of a key abortion pill, mifepristone, in a long-awaited decision that could go into effect in a week. But in Washington state, another federal judge reached the opposite conclusion Friday evening, determining that mifepristone is safe and effective and should remain available in 17 states and D.C.

That has left abortion providers like Grant’s network scrambling on multiple fronts: To assure patients and staff that nothing is changing for at least the next seven days and to attempt to determine what the conflicting rulings may mean for the future.

“We felt prepared to receive a ruling that was difficult and potentially challenging to understand,” Grant, the chief operations officer of Carafem, a group of abortion clinics and telehealth services, said. “Right now, [staff] were relieved to hear that they can go to work tomorrow and provide care just as they have the rest of this week, just as they will do the rest of next week.”

[Access to widely used abortion pill in limbo after competing federal court rulings]

But what abortion services look like beyond next week could vary from clinic to clinic if Kacsmaryk’s ruling isn’t put on pause pending the outcome of the case, as Attorney General Merrick Garland will ask the U.S. Court of Appeals for the 5th Circuit to do. Some clinics are vowing to continue prescribing mifepristone even if Kacsmaryk’s ruling remains in place, saying they won’t stop until the Food and Drug Administration directs them to. Meanwhile, others said they may switch to a different medication abortion protocol or focus instead on surgical abortions.

“The bottom line is that Judge Kacsmaryk does not give our physicians orders,” said Tammi Kromenaker, the director of Red River Women’s Clinic in Minnesota, where physicians do not expect to change protocols until getting FDA guidance.

ADVERTISEMENT

The potentially complicated landscape comes just over nine months after the Supreme Court overturned the constitutional right to an abortion, fundamentally shifting where abortions are legal in the United States. Even before the June decision, medication abortion accounted for more than 50 percent of legal abortions in the country.

In a standard 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.

“The big picture, FDA’s in a huge mess,” said Greer Donley, an associate professor of law at the University of Pittsburgh School of Law. “At this point, the FDA is going to have to try to figure out what to do with these two different orders.”

For months, some abortion providers have been bracing - and preparing - to potentially adjust the standard protocol for medication abortion. That includes switching to a misoprostol-only regimen if Kacsmaryk’s ruling takes effect. The method is used widely around the world to perform medication abortions and is considered slightly less effective than the two-step regimen and can cause more cramping and bleeding.

Since 2020, Carafem has been offering misoprostol-only as one option for ending pregnancies and has recently had providers across the nation reach out to ask questions about the process and experience for patients. The network of clinics will be seeking an opinion from its attorneys on what to do after the next seven days. The National Abortion Federation’s clinical guidelines include a line allowing for other regimens to be used if mifepristone isn’t legally available, such as prescribing only the drug misoprostol, and is planning to host a call this week for its 450 members to discuss the ruling and its implications.

“We know rulings like this can be jarring and upsetting even if we expect them,” said Melissa Fowler, NAF’s chief program officer. “But it’s not something that will deter us or our members.”

For some clinics, Kacsmaryk’s ruling could mean stopping prescribing medication abortion altogether and instead relying on surgical abortions for the time being.

Choices, an abortion clinic in southern Illinois, will immediately switch to providing only surgical abortions if the Texas ruling stands, said chief executive Jennifer Pepper. While she is hoping to offer misoprostol-only abortions to patients eventually, she said, that new protocol will take months to implement.

“The miso-only protocol is new to us,” Pepper said. “We want to make sure everyone feels they can best support patients to do that.”

Because misoprostol can cause more bleeding and cramping, Pepper said, “patients may need additional support to know those symptoms are normal so they don’t seek emergency care unnecessarily, especially in a hostile state.”

She said she fears patients could be criminalized if they present at an emergency room in a state where abortion is outlawed or highly restricted after undergoing a medication abortion. Choices plans to increase staffing after hours, so patients can call the clinic with questions while they are experiencing a misoprostol-only abortion at home.

The quick assurances that some form of abortion will continue if the ruling goes into effect came as antiabortion groups cheered the opinion. Kacsmaryk - a devout Christian with a history of antiabortion views - released his 67-page opinion on Good Friday and sided with conservative groups seeking to reverse the FDA’s approval of mifepristone as safe and effective. Kacsmaryk wrote that “FDA acquiesced on its legitimate safety concerns” and had faced “significant political pressure” to increase “‘access’ to chemical abortion.”

“The ruling reaffirms that pregnancy is not an illness and abortion is not health care,” Katie Glenn, the state policy director at Susan B. Anthony Pro-Life America, a prominent antiabortion group, said in a statement.

But in a twist, U.S. District Judge Thomas Rice in Spokane ruled on Friday night to order the FDA to preserve the “status quo” and retain access to the medication in the 17 states, along with D.C., that are behind a separate lawsuit arguing the FDA had imposed too many restrictions on mifepristone. Major medical providers - such as the American Medical Association and the American College of Obstetricians and Gynecologists - say there is “robust evidence” gathered over two decades showing the drug is safe and effective.

Friday’s dueling decisions set off a tangle of legal questions, and put the FDA into an unprecedented legal bind, legal scholars said. And it appears inevitable that the issue will move to the conservative Supreme Court, and the contradictory opinions could expedite the process.

In a statement Friday evening, the agency said it “stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses.”

The rulings left activists scratching their heads and abortion providers turning to their legal teams. Groups like the American Civil Liberties Union are gearing up to work with abortion clinics “to make sure people understand as much as they possibly can in this unprecedented situation,” said Lorie Chaiten, a senior staff attorney at ACLU.

ADVERTISEMENT

“Given how unprecedented these conflicting rulings are, I really don’t know what we’re doing in the moment because I have no idea actually what kind of landscape we’re dealing with,” said Kirsten Moore, director of Expanding Medication Abortion Access Project. If only Kacsmaryk’s ruling had come down and the drug was pulled from the market, Moore’s advocacy group was planning to quickly determine how mifepristone could get re-approved as soon as possible and what data needed to be generated to do so.

Amy Hagstrom Miller, chief executive at the abortion clinic network Whole Woman’s Health, has stated for weeks that if Kacsmaryk did attempt to revoke FDA approval of mifepristone, her clinics would continue to prescribe the drug until they receive a directive from the agency telling them to change their protocols.

“This is an FDA under Becerra, under Biden,” said Hagstrom Miller in an interview Friday night, referring to the Health and Human Services Secretary Xavier Becerra and the president, both part of a Democratic administration.

On Friday evening, Sarah Wallett was driving to a family Easter gathering when a colleague texted that the Texas ruling was out. The chief medical operating officer of Planned Parenthood of Michigan had spent her day doing what she normally does: Providing both medication and surgical abortion. She’ll be back at work next week providing abortions the same way, at least for now. Michigan is one of the 17 states the Washington judge ruled should maintain access to the pill.

“We’ll continue to see how this case plays out,” Wallett said. “But the thing I know for sure is I’m going to show up again on Monday for my patients and keep providing care, no matter what.”

ADVERTISEMENT