COLUMBUS, Ohio (WCMH) – Ohioans’ future access to a popular abortion pill remains in limbo after judges in Texas and Washington sparred on whether to pull the FDA-approved drug off the market.
In an 67-page decision Friday, federal Judge Matthew Kacsmaryk of Texas granted an anti-abortion group’s request to temporarily block nationwide access to the abortion pill mifepristone — used in half of abortions in Ohio — by issuing a preliminary injunction against its approval from the Food and Drug Administration.
Less than an hour later, Judge Thomas Rice of the Eastern District Court of Washington issued a dueling opinion: The FDA, he ruled, must preserve the “status quo” of mifepristone’s availability in at least 17 states and Washington, D.C., where Democrats sued to maintain access.
Kacsmaryk’s ruling to ban the drug nationwide has yet to take effect, meaning mifepristone remains legal in Ohio, for now, pending the U.S. Department of Justice’s appeal of Kacsmaryk’s decision. In its appeal on Friday, the Biden administration urged the Fifth Circuit Court of Appeals to temporarily halt Kasmaryk’s ruling.
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” the Justice Department said in a statement Friday. “The Department will continue to defend the FDA’s decision.”
Given the warring opinions issued in Texas and Washington, however, it’s likely that the U.S. Supreme Court will have the final word on mifepristone’s constitutionality, NBC News reported.
What’s the case about?
Kacsmaryk’s ruling marks a victory for the conservative plaintiff Alliance for Hippocratic Medicine, who argued the FDA used a flawed process to greenlight mifepristone in 2000, according to the group’s lawsuit filed by the Christian advocacy legal group Alliance Defending Freedom.
“The FDA’s approval of chemical abortion drugs has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls,” Erik Baptist, senior counsel for the Alliance Defending Freedom, said in a statement.
Mifepristone, typically taken in conjunction with misoprostol, was approved by the FDA in 2000 as a safe and effective method for terminating pregnancies up to 10 weeks. Used in 98% of medical abortions, the two-drug regimen is also considered the standard of care for miscarriage management, according to the American College of Obstetricians and Gynecologists.
With medication abortion being the No. 1 method of abortion in the U.S., millions of Americans have consumed mifepristone as part of the two-drug regimen, the American College of Obstetricians and Gynecologists said, adding that less than 1% of patients reported serious side effects in its 20-plus years of existence.
“Taking mifepristone off the market will force doctors to practice medicine in a way that doesn’t reflect the standard of care,” ACOG President Dr. Iffath Abbasi Hoskins said in a statement. “This is both wrong and bad medicine.”
Mifepristone used in nearly half of Ohio’s abortions
Of the 20,000 abortions obtained in Ohio in 2020 and 2021, nearly 50% involved mifepristone – a notable uptick since the drug’s use in only about 4% of abortions in 2015, according to data from the state department of health.
Jessie Hill, one of the lead attorneys challenging Ohio’s now indefinitely blocked six-week ban, said medication abortion is an ideal option for some abortion seekers, as it’s less invasive than surgical procedures and easier to obtain.
“The driving concern behind this lawsuit,” Hill said, “is probably that medication abortion is safe and accessible, and it’s an easier, more convenient, more accessible method of abortion for people who may live far from an abortion clinic.”
Like all abortions in Ohio, the use of mifepristone is subject to restrictions, Hill said. Patients must schedule an in-person doctor’s visit at least 24 hours before the procedure, undergo an ultrasound and can only be prescribed the drug in-person by a physician – not by a pharmacy or other health care provider.
Misoprostol is still available for Ohio patients’ use to terminate a pregnancy, but it is not as effective as mifepristone, according to ACOG.
“Although the difference in efficacy between the two treatments is relatively small, it is still real, and doctors don’t want to provide care that is less effective than we know that care can and should be,” said ACOG’s Dr. Kristyn Brandi.
While the medical community overwhelmingly considers mifepristone to be safe, Greater Columbus Right to Life Executive Director Beth Vanderkoii said past court cases, including those in Ohio, illustrate the potential hazards associated with the drug.
For instance, Stark County internal medicine physician Dr. Yousif Alhallaq was sentenced to four years in prison in 2021 after admitting to slipping his pregnant wife, who was in her 20th week of pregnancy, a mifepristone tablet without her knowledge or consent, according to filings with the State Medical Board. His wife, who called Alhallaq’s actions a “malicious attempt to kill (her) son” in 2014, began hemorrhaging shortly afterward and gave birth to a son with severe disabilities.
Vanderkoii also pointed to the potential for abuse of the two-drug regimen. In 2019, Licking County residents Kalina Gillum and Braden Mull illegally ordered misoprostol from India to terminate a third trimester pregnancy – though the pill is only intended for use on pregnancies up to 10 weeks, court records indicate. Gillum gave birth to a son, whose body was later found in a trash bag.
“Even for people who don’t necessarily agree with me or my organization on the issue of abortion, on the humanity of the unborn child, I would hope that they would at least be a little more honest about the safety risks that this medicine brings with it,” Vanderkoii said.
‘Enormous’ implications beyond abortion
Kacsmaryk’s decision to order the FDA to pull mifepristone off the market could have “enormous” implications, both for other reproductive health-related treatment and health care that extends beyond abortion, Hill said.
If the FDA has reason to believe a drug is unsafe or was erroneously approved, Hill said the agency can remove the drug from the market itself.
“Circumventing that and going straight to federal court and asking a judge to do it is something that hasn’t been done,” she said.