Access to the abortion pill, whose use has surged amid dwindling access to surgical alternatives after Roe v. Wade was overturned, may depend on the outcome of two lawsuits clashing over how the medication is regulated.
In one, a conservative group called the Alliance for Hippocratic Medicine has asked U.S. District Judge Matthew Kacsmaryk, a Texas jurist appointed by former President Donald Trump, to order the Food and Drug Administration to withdraw its September 2000 approval of mifepristone.
Introduced under the brand name Mifeprex, it’s one of two drugs prescribed together in nonsurgical abortions and commonly referred to as the abortion pill. Mifepristone blocks progesterone, a hormone required for a pregnancy to grow. The second drug in the procedure, misoprostol, causes contractions that force the fetus from a pregnant woman’s uterus.
The plaintiffs say an injunction taking mifepristone off pharmacy shelves is necessary because it was improperly approved by the FDA and poses significant health risks to women who use it.
Kacsmaryk – former deputy general counsel for the First Liberty Institute, a Christian conservative legal group that takes on religious liberty cases – promised to decide the matter “as soon as possible” after a hearing request in mid-March. He has yet to hand down a ruling.
In the second case, more than a dozen state attorneys general are hoping to achieve virtually the opposite outcome.
Dangerous Paper Trail
They are urging U.S. District Judge Thomas Rice, an appointee of former President Barack Obama in Spokane, Wash., to broaden access to mifepristone by eliminating FDA restrictions that limit who can prescribe and dispense the drug and requiring documentation of patients’ use of it for abortions.
Keeping a necessary paper trail “puts both patients and providers in danger of violence, harassment and threats of liability amid the growing criminalization and outlawing of abortion in other states,” said the 18 attorneys general, most of whom are Democrats elected to their posts.
“The availability of medication abortion has never been more important.”
They represent the states of Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota and Pennsylvania as well as the District of Columbia.
“The availability of medication abortion has never been more important,” say the attorneys general, whose states have preserved the right to terminate pregnancies.
“Medication abortion through a combination of mifepristone and misoprostol is the ‘gold standard’ for early termination of pregnancy, used by the majority of people in the U.S. who choose to have an abortion,” they argue.
The restrictions imposed on mifepristone by the FDA are an onerous set termed “Elements to Assure Safe Use,” or ETASU, that’s reserved for drugs with “inherent toxicity or potential harmfulness," they say.
Federal law allows such restrictions only for medications that show risks of serious side effects such as death or birth defects. The attorneys general say only 28 deaths have been associated with mifepristone in 5.6 million uses and none of them were caused by the drug itself.
ROE V. WADE'S DEMISE
The fatalities included cases of homicide, drug overdose and ruptured ectopic pregnancy, according to the lawsuit.
“In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk,” Washington Attorney General Bob Ferguson said when the suit was filed in late February. “The FDA’s excessive restrictions on this important drug have no basis in medical science.”
Government attorneys representing the FDA touched on similar themes in the March hearing in Amarillo, Texas.
“The public interest here would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” Julie Straus Harris, a trial lawyer with the U.S. Department of Justice, said in the hearing, a transcript of which CNBC posted on its website. “And the public interest is paramount when an injunction would deprive the public of an important medical benefit.”
Taking mifepristone off the market in the U.S. “would cause worse health outcomes for patients who rely on the availability of the drug to safely and effectively terminate their pregnancies” in cases including rape and nonviable pregnancy, she said.
Erik Baptist, an attorney representing the Alliance for Hippocratic Medicine, rejected that argument.
'NO MEDICAL BENEFIT'
“Mifepristone actually does not provide a medical benefit,” he said. “It is not a medication that treats any illness or disease.”
Instead, he claimed, its supporters “best” characterization of it is that it prevents complications in pregnancies “because it ends the life of an unborn baby before those complications present themselves.”
Since other medications and surgical procedures exist to address such complications, making mifepristone inaccessible wouldn’t cause any harm, Baptist said.
As for women unable to obtain an abortion because they live too far from surgical providers, they shouldn’t take mifepristone in the first place because they would also be unable to get medical help for any complications that followed, he said.
The alliance is arguing that FDA approval for mifepristone should be revoked in part because the agency imposed conditions in its studies of the drug that it did not require for eventual use.
Specifically, the studies required ultrasound exams – significant both because they determine accurately the age of the fetus, a factor in gauging whether it has developed too much for the drug to be safe, and because they identify an ectopic pregnancy, in which a fertilized egg develops outside the main cavity of a woman’s uterus.
Because the effects of taking mifepristone are similar to the symptoms of a life-threatening ruptured ectopic pregnancy, women taking it might not realize they are in danger, Baptist said.
Additionally, the alliance claims the FDA failed to consider how a hormone-inhibiting drug might hurt adolescent girls who use it and disregarded “substantial evidence” that chemical abortions cause even more harm than surgical alternatives.
The potentially severe complications that are possible sometimes require “critical and avoidable” treatment by doctors, he said.
Some of them oppose abortion and find themselves in “situations in which they feel complicit in the elective chemical abortion by needing to remove a baby with a beating heart or fetal remains as the only means to save the life of the woman or girl,” he said.
The organization is working with conservative medical groups in the case as well as physicians including Drs. Christina Francis, Ingrid Skop and Shaun Jester, who say they were forced to complete abortions for women who suffered medical emergencies after using mifepristone.
“The FDA’s unlawful actions have harmed women and girls for far too long,” he said.
IDEOLOGICAL VS. SCIENTIFIC
The medical profession writ large, however, has a sharply different assessment of the status quo.
The American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, the professional group for obstetricians with additional training in high-risk pregnancies, say the position taken by the Texas plaintiffs is ideological rather than scientific.
“Their request is not based on rigorous scientific review and analysis but on speculation and the personal opinions” of a small number of physicians, the groups argue in an amicus curiae brief.
The scientific evidence supporting mifepristone’s safety and efficacy is “overwhelming,” they add.
Mifepristone “is one of the most studied medications prescribed in the U.S. and has a safety profile comparable to ibuprofen,” the active ingredient in over-the-counter painkillers such as Motrin and Advil, they argue.
Evidence collected since the FDA’s 2000 decision has confirmed the agency’s original findings, they maintain: “Serious side effects occur in less than 1% of patients and major adverse events—significant infection, blood loss or hospitalization—occur in less than 0.3% of patients. The risk of death is almost non-existent.”
Eliminating access to mifepristone would leave even more woman unable to obtain abortions than have already been affected by the sharp restrictions in conservative states since Roe v. Wade was overturned in 2022, reproductive rights advocates argue.
That decision, authored by U.S. Supreme Court Justice Samuel Alito on behalf of six justices appointed by Republican presidents, declared that abortion is different from other rights affirmed by justices because it “destroys fetal life.”
He noted that Democrats lacked the votes to do so at the time. They have even fewer now, after losing control of the House of Representatives to a slim Republican majority in the fall of 2022.