US appeals court rules to restrict use of abortion pills News
Janni Rye, CC0, via Wikimedia Commons
US appeals court rules to restrict use of abortion pills

The US Court of Appeals for the Fifth Circuit ruled Wednesday to restrict the use of mifepristone, an abortion pill, by prohibiting its delivery by mail or prescription via telemedicine. However, the ruling will not take immediate effect due to an April ruling from the US Supreme Court temporarily protecting access to the drug.

The appeals court held that the US Food and Drug Administration (FDA) did not adequately consider safety risks before removing a condition to the drug’s use that required the drug to be prescribed and dispensed in person. According to the opinion:

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. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.

Wednesday’s decision comes from a lawsuit brought by a coalition of doctors and medical organizations alleging that the FDA’s actions failed to protect patients and providers and violated the Administrative Procedure Act. The FDA approved the use of mifepristone as part of a two-drug regimen to induce abortion in 2000. At that time, it also set forth several safety measures intended to prevent serious side effects. In 2016 the FDA amended the safety measures before approving a generic version of the drug in 2019. Finally, in 2021 the FDA amended the safety measures again to remove a condition that required the drug to be prescribed and dispensed in person.

Wednesday’s decision affirmed a stay order issued by a federal court in Texas to prohibit the prescription of mifepristone via telemedicine and delivery via mail. However, the court vacated the lower court’s decision to overturn the FDA’s initial approval of the drug, as well as its decision to overturn the approval of the generic version. The decision is subject to a decision from the Supreme Court before it can take effect.

US Department of Health and Human Services (HHS) Secretary Xavier Becerra released a statement condemning Wednesday’s decision. In it, he noted that the decision “undermines our nation’s entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA.” A statement from Vice President Kamala Harris referred to the lawsuit as “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.”