The US's highest court will review an appeals court's decision to restrict access to mifepristone
The floor is set for the US Supreme Court to once again weigh in on abortion, this time specifically on access to mifepristone—one of two pills used in medication abortions, along with misoprostol. The US Food and Drug Administration (FDA) approved the drug in 2000, but that decision has recently come under scrutiny from anti-abortion groups that, following the overturning of Roe v. Wade last year, seek to further restrict access to family planning in the country.
The New Orleans-based US Court of Appeals for the Fifth Circuit ruled yesterday (Aug. 16) that the most common method of terminating pregnancies in the US should remain legal, but with restrictions to its availability. The pills should not be mailed to patients or prescribed via telemedicine, leaving in-person doctor visits as the only option for administration, a three-judge panel—all staunchly conservative—concluded.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time,” Judge Jennifer W. Elrod, a George W. Bush appointee, wrote in the majority opinion.
The Justice Department, which is representing FDA in the case, is “committed to defending the FDA’s scientific judgment and protecting Americans’ access to safe and effective reproductive care,” a spokesperson told Axios.
This ruling in the ongoing legal tussle to undo the FDA’s 23-year-old approval of mifepristone won’t have immediate consequences. The Supreme Court earlier ruled that mifepristone remain available until the appeals process is over.
The apex court can now act in one of two ways: Deny review and leave this appeals court’s ruling, curbing but not eliminating access to the pill, in place; or it could agree to hear the appeal entirely.
(✅= Allow, ❌= Revoke)
✅ The initial approval of mifepristone in 2000.
❌ The 2016 decision to allow nurse midwives and other providers—not just doctors— to prescribe mifepristone and to reduce the required number of in-person visits from three to one. Also, the decision to extend the authorization of mifepristone until 10 weeks into pregnancy instead of seven.
✅ The approval of generic mifepristone in 2019.
❌ The lifting of the in-person dispensing requirement altogether in 2021, allowing abortion pills to be prescribed via telemedicine and mailed to patients.
June 2022: The Supreme Court overturns Roe v Wade, stripping away the constitutional right to abortion.
November 2022: The Alliance of Hippocratic Medicine, an anti-abortion group, sues the FDA with the aim of overturning the agency’s approval of abortion pills.
January 2023: FDA approves a modified mifepristone REMS, which lifts the in-person dispensing requirement and allows retail pharmacies to dispense mifepristone pills to those with prescriptions, including by mail, provided they are certified under special safety rules for the drug.
April 2023: A ruling issued by Judge Matthew Kacsmaryk in Texas blocks the FDA’s 2000 approval, effectively bans access to abortion pill nationwide. The Biden administration files an emergency appeal. The Supreme Court steps in, ruling that mifepristone must remain available until the appeals process concludes.
[T]his lawsuit is a threat to a woman’s freedom to make decisions about her own body and another step towards the ultimate goal of a nationwide abortion ban. It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA. Americans across the country should be able look in their medicine cabinets and know that FDA-approved medication prescribed by a doctor will remain available. This decision stands between doctors and their patients. —US vice president Kamala Harris in a statement on Aug. 16, 2023
5.6 million: Number of women who’ve used mifepristone to terminate pregnancies in the US through June 2022
53%: Medication abortion, or the abortion pill, accounts for the majority of US abortions as of 2022. It’s considered extremely safe
97%: Effectiveness of terminating pregnancies with mifepristone within the first two months
40%: Share of US women who live in a county without an abortion provider, who would greatly benefit from telemedicine and mail-in pills
<1%: Share of patients needing hospitalization, according to medical experts
28: Reported deaths in patients associated with mifepristone since the product was approved in September 2000, as of June 30, 2022
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