CLEVELAND, Ohio — Northeast Ohio patients, providers and advocates on both sides of the issue are keeping an eye on a Texas court. The Department of Justice is now appealing a Texas federal judge’s ruling to halt the Federal Drug Administration’s (FDA) approval of a common abortion medication.
U.S. District Judge Matthew Kacsmaryk's ruling came out Friday and caused brief confusion for staff at the Preterm abortion clinic in Cleveland.
“We had patients scheduled for that Saturday for medication abortions. And we had to wait for our legal counsel to tell us whether we could see those patients for their abortion the next day,” said Preterm Director of Finance Aimee Maple.
Kacsmaryk’s decision would stop the prescription and distribution of Mifepristone pills seven days later on Friday, April 14. Maple said Preterm uses the drug in about 10-20% of the abortions the clinic performs. She estimated about 40% of abortion patients less than 10 weeks pregnant receive the pill.
Mifepristone is typically prescribed with another medication called misoprostol. The drug cocktail is approved to end a pregnancy through 10 weeks of gestation and has been on the market for two decades.
Anti-abortion groups applauded the Texas ruling, pointing to the adverse effects of Mifepristone.
In a statement issued Monday, Ohio Right to Life’s Director of Communications, Elizabeth Marbach, said, “From the beginning, the FDA has fast-tracked the approval of these dangerous drugs for the sole purpose of politics and convenience, and it is time that we end that.”
An FDA summary notes 4,213 adverse events among the 5.6 million patients who have taken Mifepristone from the drug’s approval date in 2000 through June 2022. The data includes 1,048 hospitalizations, 71 severe infections, and 28 deaths.
Maple said she has never heard or seen serious effects from Mifepristone and the clinic took part in the FDA’s original trials.
“We kind of take this personally, because we took part in developing that medication. And it’s a medication we administer frequently when that’s their choice,” she said.
The DOJ and drug manufacturer Danco have filed appeals to the 5th U.S. Circuit Court of Appeals, reiterating the safety of the pill approved more than two decades ago.
"When Mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen," the appeal said.
If the higher court does not halt Kacsmaryk’s ruling earlier, the prescription and distribution of Mifepristone would stop by Friday.
“If Mifepristone’s approval is revoked for a period of time, in Ohio it will become unavailable almost immediately,” said Case Western Reserve University Law Professor Jessie Hill.
Around the same time as the Texas decision, another federal judge in Washington issued a conflicting order blocking the FDA from rolling back access to the pills. Hill explained it applies only to states involved in a lawsuit and does not include Ohio.
“The Washington decision, in our opinion, orders the FDA to continue to violate federal law and relax safety standards for Mifepristone even more than they already are,” said Right to Life Ohio President Michael Gonidakis in a statement Monday. “With these competing decisions and possibly competing decisions from different federal appeals courts, the United States Supreme Court will be required to have the final say.”
Hill said the Texas ruling could have broader implications, not only for access to abortion medication but also for the FDA’s authority to regulate other medications.
“This could have implications for all kinds of medications that others might want to challenge. That might be vaccines that are controversial or it could be just competitors that want to challenge the approval of a competitor company’s drugs,” she said,
After the 5th U.S. Circuit Court of Appeals rules on the case, it could make its way to the U.S. Supreme Court. If the ruling is upheld, Ohioans would still have access to other abortion medication up to 10 weeks gestation and surgical abortion up to 21 weeks and six days after the most recent menstruation period.
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