The Food and Drug Administration headquarters in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
Ohio reproductive rights providers and advocates are keeping an eye on federal discussions about a longtime FDA-approved drug used in medication abortion, while maintaining a resolute message in a state with constitutional protections for abortion.
The head of the U.S. Department of Health and Human Services has indicated he wants the federal Food and Drug Administration to re-review pills used in abortion procedures for safety and effectiveness.
Mifepristone has been FDA-approved since September 2000, and the first generic version was approved in April 2019. Just last month, the FDA approved another generic form of the medication.
Patricia Zettler, a law professor at Ohio State University who studies the FDA, said the request for a new review seems unusual, and it’s also unusual considering drug companies including those that make mifepristone are required to participate in a Risk Evaluation and Mitigation Strategy program, which the FDA uses to “help ensure the benefits of the medication outweigh its risks.”
According to the FDA, the Risk Evaluation and Mitigation Strategy for mifepristone require that the drug be prescribed by a qualified health care provider, that the patient sign a patient agreement form explaining the risks of the treatment and that the drug be distributed by a certified pharmacy.
“The mifepristone REMS programs is a closed system, meaning prescribers, pharmacies and distributors are certified or authorized and verified under the REMS prior to distribution or dispensing of the drug,” according to the FDA.
But Zettler said because of abortion rights (and anti-abortion rights) movements in individual states and moves like HHS Secretary Robert F. Kennedy Jr.’s to ask for renewed scrutiny, the drug has been “getting a lot of attention.”
“Policy preferences are generally not permissible when we’re talking about drug approval,” Zettler said.
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Medication abortion is typically done with a combination of mifepristone and misoprostol.
It has often been a choice for those without easy access to reproductive clinics or without reliable transportation to get to an appointment.
It’s also considered a less-invasive alternative to surgical abortion.
The newest annual abortion report from the Ohio Department of Health showed medication abortions were used in more than 13,000 abortions in the state, representing more than 46% of all reported abortions in 2024.
A total of 196 post-abortion complications were reported in the 21,829 abortions conducted in Ohio, according to state data.
No deaths were reported in 2024.
In testimony before an Ohio House committee discussing a bill related to abortion funding, Ohio State epidemiology professor Dr. Alison Norris, spoke on the effectiveness of the drug.
Norris is also a co-principal investigator for the Ohio Policy Evaluation Network, a group of academic researchers who study abortion and contraception developments and impacts.
Norris told legislators during the committee hearing that more than 100 peer-reviewed studies over 25 years “create a strong scientific evidence-base to show mifepristone is safe.”
“Scientific consensus is that serious adverse events amongst users of Mifepristone occur less than 0.03% of the time,” Norris said.
Norris also pointed to research using CDC data that showed more likelihood of maternal death in childbirth than in abortion.
The American College of Obstetricians & Gynecologists also used the information in saying abortion is a “safe medical intervention.”
“The risk of complication or mortality from abortion is less than the same risk from common procedures like wisdom tooth removal, cancer-screening colonoscopy and plastic surgery,” the group said on its website.
The group went further to say that restricting access to abortion “forces some pregnant people to continue their pregnancies to delivery, leaving them to face the many health risks associated with pregnancy and childbirth.”
Ohioans are facing the risk of restricted access to reproductive care in some areas, with the closure of southwest Ohio Planned Parenthood clinics, and staffing reductions in the Planned Parenthood of Greater Ohio clinics, which the facilities said were due to cuts to federal Medicaid funding and other federal resources.
Despite the closures and workforce limitations, Ohio clinics have encouraged clients to use telehealth for care (abortion and otherwise).
Planned Parenthood of Greater Ohio announced a plan to expand medication abortion services in Mansfield in September.
“Medication abortion is a safe and effective option for ending a pregnancy,” said Dr. Bhavik Kuma, chief medical officer for the greater Ohio affiliate, in a statement.
“Planned Parenthood will always follow evidence-informed standards and medical best practices to provide safe, high-quality abortion care and information to patients who come to us.”
Even with a request from the HHS secretary to once again review the medication abortion drug, the process is time-consuming, according to Zettler.
It would include reviewing evidence, assessing whether a different determination can be made about the drug, and about whether the benefits outweigh the risks, she said.
“So, the most important takeaway from this for states is that nothing has changed,” Zettler said. “Nothing’s going to change tomorrow and nothing’s changed today.”
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