How does medication abortion work? Is it safe?

Medication abortions — a two-step regimen of mifepristone and misoprostol — now account for over 50 percent of legal abortions in the United States. A patient first takes one mifepristone pill, which blocks the hormone progesterone, preventing a pregnancy from progressing. 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 two-step procedure is standard in the United States and is approved as safe for the first 10 weeks of gestation, which begins on the first day of a person’s last menstrual cycle. (The World Health Organization says medication abortion is safe in the first 12 weeks of pregnancy.) It is also possible to terminate a pregnancy using just misoprostol, a procedure that requires three doses of four pills each. 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.

How could the lawsuit affect abortion access?

If Kacsmaryk suspends FDA approval of mifepristone, it would upend access to the standard two-step medication abortion regimen, though the exact way in which that would happen remains unclear. In states where abortion is legal, clinics could limit their offerings to surgical abortions, which require far more time and resources than pills. But many providers say they will continue to offer medication abortions using only misoprostol. Providers expect longer wait times for patients and a mad rush to vet and implement new procedures. Some say they are stockpiling mifepristone in advance of the ruling, while it is still FDA-approved, and may continue using that supply of the drug in the weeks or months after a ruling. Regardless of Kacsmaryk’s ruling, experts say that Aid Access, a nonprofit based in Austria, most likely will continue to ship generic mifepristone from India to consumers in the United States. “There will still be ways to get the two-pill regimen,” said Abigail Aiken, associate professor at the University of Texas at Austin. In a recent column in Slate , several prominent law professors noted that withdrawing approval of any drug is a lengthy process that requires FDA hearings and deliberations. In addition, they wrote, the agency could allow mifepristone to stay on the market under a policy known as “enforcement discretion,” used for products that don’t pose safety concerns.

What does the mifepristone lawsuit allege?

The FDA has repeatedly deemed the two-step medication abortion protocol to be safe and effective. But the lawsuit argues that the regulatory agency never should have approved mifepristone back in 2000, claiming the government purposely ignored what the plaintiffs contend are harmful side effects. Leading organizations of physicians and other public health professionals have strongly disputed those allegations. These groups have told Kacsmaryk that reversing FDA approval of mifepristone would “cause profound and irreparable harm to patients across the country.” Medication abortions with mifepristone have “an exceptionally low rate of complications,” according to their brief.

How can I get abortion pills now?

Both mifepristone and misoprostol require a prescription from a certified health-care provider. In states where abortion is legal, patients can pick the drugs up at clinics or doctors’ offices or order them by mail. In January, the FDA made a long-sought rule change that allows retail pharmacies to dispense abortion medication pills directly to consumers in states where the procedure is legal. But analysts say that implementing the requirements to dispense mifepristone, including being able to maintain provider confidentiality and track shipments, will take some time and may dissuade smaller stores from participating. In early March, under pressure from antiabortion advocates, Walgreens said it would withhold sales of mifepristone in Alaska, Iowa, Kansas and Montana regardless of how Kacsmaryk rules.Some states have adopted strategies to restrict medication abortions including establishing early gestational age limits for the procedure or requiring a physician to be present when the patient takes the medication. Arizona has banned mailing the pills , according to the Guttmacher Institute, a nonprofit research center based in New York and Washington that supports abortion rights. Activists have devised clandestine networks to distribute the drugs in states with bans, often importing the medications from Mexico and then relaying them to pregnant women who have reached out on social media.

Could the lawsuit affect the FDA more broadly?

The Justice Department wrote in a court filing that the lawsuit has the potential to undermine the country’s process for regulating pharmaceuticals. “The injunction request is extraordinary and unprecedented,” the Justice Department said in its brief. “Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market.” Congress created an “onerous and difficult process” for the FDA to take an approved drug off the market, according to Greer Donley, a professor at the University of Pittsburgh School of Law and one of the authors of the Slate column — which means that, once the FDA approves a medication, drug manufacturers can reasonably assume the approval is permanent and binding. “[If] one judge, who literally has no scientific background, can come in and circumvent that whole process and order the FDA to remove a product from the market, it’s just potentially very concerning,” Donley said. She cited concerns about potential backlash to drugs for stigmatized conditions, such as PrEP to reduce the risk of contracting HIV or drugs for gender-affirming care: “This really does have the potential to disrupt a lot of the assumptions that are baked into the drug-approval process.”

How can one judge in Texas issue a nationwide ruling?

The decisions of individual district court judges typically apply only to the specific parties in a case, but their rulings can sometimes have national implications. Nationwide injunctions — which have become increasingly common and controversial in recent years — are typically issued to block broad enforcement of a federal statute or policy. Still, in a high-stakes case like this one, a federal district court judge is rarely the final stop. However Kacsmaryk rules, the case probably will be appealed to the conservative U.S. Court of Appeals for the 5th Circuit, and could eventually make its way to the Supreme Court.

When is the ruling expected?

It is possible the judge will rule at Wednesday’s hearing, which he took steps not to publicize right away because of concerns about threats and protests. But it is more likely that he will issue a written ruling sometime after the hearing. If Kacsmaryk grants the request for an injunction, he would have the option of staying the injunction to allow time for an appeal.

Isn’t abortion legally protected in many blue states?

Yes. But state laws only protect access to abortion in a general sense, according to legal experts. They don’t protect any particular form of abortion, allowing Kacsmaryk to halt use of mifepristone from California to Illinois to New York.

What more do we know about Judge Kacsmaryk?

The judge for the Amarillo division of the Northern District of Texas, Kacsmaryk was nominated by President Donald Trump. Since joining the federal bench in 2019, he has delivered a number of high-profile wins for conservative groups on issues such as contraception and immigration. His nomination drew sharp criticism from Democrats on the Senate Judiciary Committee, who quizzed Kacsmaryk on the anti-LGBTQ statements he had made while working for the First Liberty Institute, a conservative legal advocacy group. A recent Washington Post story on Kacsmaryk, based on 20 interviews with people who know him, revealed that he has been deeply opposed to abortion since his young adulthood.

Who brought the lawsuit?

The conservative legal group Alliance Defending Freedom brought the lawsuit on behalf of four antiabortion organizations and four doctors who say they have treated patients with mifepristone. Abortion rights advocates have accused the group of “judge shopping,” filing in Kacsmaryk’s district because they believe the judge may be more inclined than others to rule favorably in the case. Lawyers for Alliance Defending Freedom would not say whether Kacsmaryk’s presence affected their decision to file in Amarillo.

Politics

Can I get a medication abortion? How a Texas lawsuit could change access

Judge Matthew Kacsmaryk could upend FDA approval of mifepristone, a key abortion drug, when he rules on a federal lawsuit in Texas

By Caroline Kitchener

Ann E. Marimow

Laurie McGinley

Rachel Roubein

and

Frances Stead Sellers

Updated March 13, 2023 at 2:39 p.m. EDT|Published March 1, 2023 at 10:00 a.m. EST

Franz Theard watches a patient from Texas take mifepristone, the first medication in a medical abortion, with medical assistant Elizabeth Hernandez, at his clinic, Women’s Reproductive Clinic of New Mexico in Santa Teresa on Jan. 13. (Evelyn Hockstein/Reuters)

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8 min

A federal judge in Texas will hold a hearing Wednesday in a case that could halt distribution of a key abortion drug — a decision that would have sweeping implications for abortion access across the country, including in Democratic-led states where abortion rights are protected.

The lawsuit, filed by several antiabortion groups and doctors against the U.S. Food and Drug Administration, aims to undo the decades-old government approval of mifepristone, one of the two drugs used in medication abortions.

Abortion rights advocates say that the implications would be “catastrophic” if the judge in the case, Matthew Kacsmaryk of the Northern District of Texas, sides with antiabortion groups. Such a ruling could trigger the furthest-reaching limit on abortion access since the Supreme Court overturned Roe v. Wade in June.

Here’s a look at medication abortions and how the case could shape abortion care nationwide:

Roe v. Wade and abortion access in America

In June 2022 the Supreme Court struck down Roe v. Wade, which for nearly 50 years has protected the right to abortion. Read the full decision here.

What happens now? The legality of abortion is left to individual states. The Post is tracking states where abortion is banned or under threat, as well as Democratic-dominated states that moved to protect abortion rights enshrined in Roe v. Wade.

Abortion pills: Abortion advocates are concerned a Texas judge’s upcoming abortion pill ruling could halt over half the legal abortions carried out nationwide. Here’s how the ruling could impact access to the abortion pill mifepristone.

Post-Roe America: With Roe overturned, women who had secret abortions before Roe v. Wade felt compelled to speak out. Other women, who were and seeking abortions while living in states with strict abortion bans shared also shared their experience with The Post through calls, text messages and other documentation that supported their accounts. Here are photos and stories from across America since the reversal of Roe v. Wade.