WASHINGTON (WJHL) — Rep. Diana Harshbarger has introduced a bill to restrict the availability of the abortion pill mifepristone.
Mifepristone is taken with another drug, misoprostol, to terminate pregnancies up to 10 weeks.
Harshbarger’s bill would roll back a recent ruling by the Food and Drug Administration (FDA) allowing the pill to be dispensed by retail and mail-order pharmacies. Previously, mifepristone could only be picked up in person at specialty clinics and doctor’s offices.
The FDA approved the drug in 2000 under the brand name Mifeprex, but the agency imposed restrictions over safety concerns. The requirement that the drug be picked up in person was temporarily suspended during the COVID-19 pandemic. Then, after conducting a review of the drug, the FDA determined that data supported loosening restrictions on the drug.
Harshbarger, who is a pharmacist, disagrees with the decision.
“The FDA’s policy change for Mifepristone is the latest example of President Biden’s crusade toward abortion on-demand at any cost, even at the expense of women’s health,” the congresswoman said in a statement. “Chemical abortion drugs have been associated with staggering numbers of life-threatening complications. Every woman in America deserves to know the heightened risks involved with chemical abortions before they make a life-altering decision. My bill restores common-sense and proper safety prescriber requirements for the dispensing of these dangerous abortion drugs.”
According to an FDA estimate, around 5.6 million women used mifepristone to terminate a pregnancy between 2000 and June 2022. During that time, there were 28 reported deaths in patients associated with the drug, but the FDA says it is unclear if the deaths were caused by the drug or other factors.
The American College of Obstetricians and Gynecologists (ACOG) lauded the recent FDA ruling and called it “an important step forward in securing access to medication abortion.”
“ACOG has advocated for many years for the in-person dispensing requirement to be removed from the risk evaluation and mitigation strategy (REMS) for mifepristone,” ACOG said. “There is no clinical evidence that in-person dispensing improves the safety of this medication or patient outcomes; instead, this requirement unnecessarily restricted patient access to a safe and effective medication.”
The FDA’s recent ruling did not lift all of the restrictions on mifepristone. Doctors must meet certain qualifications, including being able to handle complications stemming from the use of the drug, and obtain special certification in order to prescribe it. Pharmacies must also obtain certification to dispense it.
The federal ruling also does not override restrictions imposed by states, such as Tennessee’s ban on distributing abortion pills by mail or delivery service.
If Harshbarger’s bill clears the House, potential roadblocks to it becoming law remain with Democrats in control of the White House and Senate.