A judge’s ruling threatens access to a common abortion drug. What does that mean for Texas?

A Texas federal judge revoked long-standing FDA approval of a drug used to self-manage abortions and miscarriages. Abortion rights supporters say that will have wide-ranging repercussions for Texans, who already face extreme barriers to accessing reproductive care.

By Bekah Morr, KERA April 12, 2023 10:01 am, , ,

From KERA:

About nine months ago, Texan Amanda Zurawski and her husband were thrilled to discover she was pregnant. After 18 months of grueling fertility treatments, they had finally conceived a baby girl they planned to name Willow.

But about four months in, while Zurawski was planning her baby shower, their world was upended. She told reporters at a press conference in Austin last month she’d dilated prematurely because of a condition called cervical insufficiency.

Doctors told Zurawski the loss of her daughter was inevitable. In the midst of mourning their loss, she asked her health care providers what could be done to terminate the pregnancy and protect her from a deadly infection.

Their response: nothing.

Because cardiac activity could still be detected in the fetus, the team could not intervene until Zurawski was sick enough for the hospital ethics board to consider her life at risk and permit an abortion procedure. That’s because of Senate Bill 8, the so-called “heartbeat law” that bans abortion after roughly six weeks.

Three days later, Zurawski said she developed sepsis and entered intensive care.

“I cannot adequately put into words the trauma and despair that comes with waiting to either lose your own life, or your child’s life,” she said. “Would Willow’s heart stop, or would I deteriorate to the point of death?”

AP / Senate Judiciary Committee

In this image from video from the Senate Judiciary Committee, Matthew Kacsmaryk listens during his confirmation hearing before the Senate Judiciary Committee on Capitol Hill in Washington, on Dec. 13, 2017. Kacsmaryk, a Texas judge who sparked a legal firestorm with an unprecedented ruling halting approval of the nation's most common method of abortion, Friday, April 7, 2023, is a former attorney for a religious liberty legal group with a long history pushing conservative causes.

Abortion is already nearly impossible for Texans to access. Three laws in the state ban the procedure, including a trigger law that took effect a month after the U.S. Supreme Court issued its ruling on Dobbs v. Jackson, the case that overturned the precedent set by Roe v. Wade. It makes performing an abortion a felony punishable by up to life in prison unless the pregnant patient’s life is at risk.

Now, doctors and abortion rights advocates fear a federal court ruling last week will lead to even more cases like Zurawski’s — people forced into dangerous birthing situations because they lack access to life-saving reproductive health care.

On Friday, Judge Matthew Kacsmaryk issued a ruling that threatens to remove the decades-long approval of the abortion drug mifepristone. That decision is on hold until at least Friday as the Justice Department appeals, and a Washington judge issued his own ruling blocking the FDA from removing its approval.

But as the case makes its way through the courts, supporters of abortion rights fear the medication could be removed from the market nationwide — making access to abortion care in Texas even more difficult.

“The reality is, banning abortion never stops the need for abortion,” said Dr. Bhavik Kumar, an abortion provider in Texas. “As a physician, it is my ethical duty to ensure that care is safe, patient-centered and accessible. Attacks like this on a critical and safe medication make my job — and that of other compassionate health care providers — much more difficult.”

Wide-ranging repercussions

More than half of all abortions in the United States are self managed using abortion medication, according to the Guttmacher Institute, an NGO focusing on reproductive health research and policy.

Typically, mifepristone is used in combination with another drug, misoprostol, to end a pregnancy in the first 10 weeks — whether that be for an elective abortion or in response to a miscarriage.

Misoprostol can be used alone to terminate a pregnancy, but only has an 80-85% success rate and a higher risk of complications, according to Ipas, an international, non-governmental organization working to increase access to safe abortions and contraception.

That’s compared to a 95% success rate and complication rates of less than 1% when the drugs are used together.

“I’m extremely nervous, moving forward, about what this could look like,” said Kara Sugihara, a registered nurse in Austin who has previously prescribed mifepristone.

Sugihara, a former nurse practitioner who moved to Texas from Massachusetts in 2022, said removing Mifopristone from the market will have the biggest impacts on Black women — who have the highest rate of maternal mortality in Texas — and people who live in low-income communities, especially those in rural parts of Texas.

“When you have an average distance of over 500 miles away from the nearest abortion clinic prior to a total abortion ban, you’re already facing extreme barriers to getting an abortion at all, let alone pills,” Sugihara said.

Eric Gay / AP

Abortion-rights supporters (foreground) try to disrupt an anti-abortion march to the Texas Capitol during a Texas Rally for Life on Jan. 24 in Austin, Texas.

Arguments for and against mifepristone

Anti-abortion groups praised last week’s ruling in the lawsuit, Alliance for Hippocratic Medicine v. FDA.

The suit was filed in the Northern District of Texas in November by a coalition of anti-abortion physicians and organizations. The plaintiffs argued the FDA did not sufficiently study mifepristone’s safety and efficacy when it approved the drug’s use in 2000, despite the agency reviewing the drug in 20002016 and as recently as this year.

The Alliance of Hippocratic Medicine, one of the plaintiffs in the suit, argued that doctors who are part of this group have been forced to treat patients who have experienced complications like heavy bleeding.

“We’re seeing women who are hemorrhaging,” said Dr. Donna Harrison, the group’s board chair. “We’re seeing women who are lacking informed consent about the complications of abortions … because of the way in which the FDA has allowed for the dispensing of this dangerous abortion drug.”

Elisabeth Smith, director for state policy and advocacy for the Center for Reproductive Rights, pointed to multiple studies — including a review by the Government Accountability Office in 2008 — confirming mifepristone’s safety and efficacy.

“Five million people have used this drug since it was first approved in the year 2000,” Smith said. “Mifepristone has better outcomes than really common over-the-counter drugs like Tylenol, for example. So, the idea that safety is an issue is just absolutely false.”

Julia Reihs / KUT

The party wants to abolish abortion and removed the "abortion homicide exemption" for physicians in the penal code, meaning they could be criminally charged for performing the procedure in some cases.

Smith added that the decision could worsen health outcomes across the country, but especially in places like Texas.

“There will be more people who are forced to have abortions later in pregnancy, and there will be people who will be forced to continue pregnancies against their will,” Smith said. “It will also affect people who want to continue their pregnancies but have obstetric complications and need access to this drug to preserve their life and health.”

Safety was just one argument made by the plaintiffs in the case. The groups also took issue with the FDA’s recent decision to allow patients to receive mifepristone through the mail via telehealth.

In January, the agency finalized a rule change that expanded availability of abortion pills to include large chain pharmacies and mail-order companies. The plaintiffs argued that’s illegal.

“There are long-standing, federal, criminal laws prohibiting and restricting the distribution of chemical abortion drugs by postal mail,” said Erik Baptist, an attorney with the Alliance Defending Freedom.

A main argument put forth by Baptist, and which Kacsmaryk agreed with, was that the Comstock Act of 1873 banned the shipping of abortion drugs through the mail. The act as written made it illegal to send any obscene materials or articles intended for “producing abortion” by mail.

But critics have pointed out the Comstock Act hasn’t been enforced for almost 100 years.

“This is a really meritless claim by people who will really cling to any argument to try to end access to abortion and to make it as inaccessible as possible,” said Carrie Flaxman, senior director of public policy litigation and law for the Planned Parenthood Federation of America. “[The Comstock Act] is not part of what the FDA is supposed to consider, in any event, in approving drugs.”

Allen G. Breed / AP

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., March 16, 2022. Health and Human Services Secretary Xavier Becerra on Sunday, April 9, 2023, stressed that women for now continue to have access to the abortion medication mifepristone after the Texas judge stayed his ruling for a week so federal authorities could file a challenge. The drug was approved by the FDA in 2000.

The DOJ also reviewed the law following last June’s Dobbs decision and said it “does not prohibit the mailing, or the delivery or receipt by mail, of mifepristone or misoprostol where the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

The accessibility of abortion drugs through the mail is also the target of a lawsuit from Texas Attorney General Ken Paxton. That suit challenges guidance from the U.S. Department of Health and Human Services that says pharmacies must provide abortion-inducing drugs to people seeking elective abortions, per an executive order from the Biden administration last July.

Biden’s executive order also identified access to medication abortion as one of five priorities in his administration’s plan to protect access to reproductive health care after the Dobbs decision.

The future of abortion rights in Texas

For now, mifepristone’s status is still up in the air. Legal experts say because of the split decision between federal courts in Texas and Washington, the case will likely wind up in front of the U.S. Supreme Court.

In a conference call in the weeks leading up to Friday’s decision, former Texas state Sen. Wendy Davis said a ruling striking down FDA approval of mifepristone would have a detrimental impact on doctors’ ability to provide safe and effective reproductive health care.

But, she said, that’s been a trend in recent years as Texas continues to restrict abortion.

“When Justice Alito wrote [the majority opinion] in the Dobbs case, he talked about the fact that we would simply be returning to a situation where the states would now decide,” she said. “But it is very clear that anti-abortion zealots, like the plaintiffs in this particular case, are not in any way going to accept that state by state.”

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