Fifth Circuit Appeals Court Restricts Access to Abortion Pill

On Wednesday, August 16, 2023, the United States Court of Appeals for the Fifth Circuit issued a decision that will restrict access to medication abortions. While the new ruling does not reverse the approval of mifepristone by the US Food and Drug Administration (FDA), it will change an amendment allowing the pills to be distributed through mail.

This decision to effectively restrict access to reproductive health services has been debated since January 13, 2023, when the Alliance for Hippocratic Medicine filed a lawsuit against the FDA, hoping to reverse approval of mifepristone, one of the two pills required for a medication abortion.

In April 2023, Mathew Kacsmaryk, a Trump-appointed federal judge in Texas, voted in favor of the Alliance for Hippocratic Medicine, issuing a preliminary injunction to invalidate mifepristone’s approval, which dates back 23 years.

Kacsmaryk’s decision was met with disapproval by many healthcare professionals and government organizations.

Shortly after his decision, the US Supreme Court (SCOTUS) granted a stay that lifted restrictions pending final rulings on the abortion pill. The decision — issued on April 21, 2023, with statements from Supreme Court Justice Samuel A. Alito, Jr. — was announced two weeks after Kacsmaryk’s decision.

Until yesterday, this stay, granted by SCOTUS, maintained access to the abortion pill, depending on state-level abortion restrictions. However, the decision by the appellate court to enforce restrictions alters this ruling and the reproductive health landscape.

The appeal considered four factors of mifepristone approval: the initial approval in 2000, amendments made in 2016, generic approval in 2019, and the 2021 non-enforcement decision. Conclusions by this circuit vacated and affirmed different parts of the district court ruling by Kacsmaryk.

The new ruling, while allowing the sale of the drug, will reverse the 2021 non-enforcement decision, which lifted restrictions that required the medication to be prescribed and dispensed in person. Despite the continued availability of the drug, patients are now more likely to face barriers to care.

“Today’s decision undermines our nation’s entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA. This decision threatens Americans’ right to access the medications they need and, if it stands, would have a devastating impact on women’s health by restricting their access to reproductive health care,” noted HHS Secretary Xavier Becerra in the HHS press release.

Additionally, Vice President Harris issued a statement that said, “This 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 to 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.”