Conflicting court decisions have cast doubt on the future of the abortion pill mifepristone, as well as the federal government's power to approve and regulate drugs. Mifepristone, a widely used medication in the U.S. for ending early-stage pregnancies and managing miscarriages, was first approved by the Food and Drug Administration (FDA) in 2000 after the agency determined its benefits outweighed its risks.

Recently, a federal judge in Texas challenged the FDA's approval, issuing an injunction that could suspend the approval across the nation. However, the Justice Department is appealing to prevent the injunction from taking effect. Meanwhile, a federal judge in Washington state issued a separate ruling that prevents the FDA from removing the drug from the market.

The uncertainty surrounding mifepristone's future has prompted some states to stockpile the drug, while major pharmaceutical companies have expressed support for the FDA. Some lawmakers, both Democrats and Republicans, have called on the Biden administration to disregard the Texas ruling, though the White House has declined, citing concerns over setting a "dangerous precedent."

Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania, describes the Texas ruling as "unprecedented." She explains that pharmaceutical companies typically conduct clinical trials, assess the safety and efficacy of new drugs, and submit extensive data to the FDA, which is granted authority by Congress to determine market availability for new products.

Fernandez Lynch notes that over 100 studies spanning 30 years support mifepristone's safety. However, a group of anti-abortion doctors and organizations filed a lawsuit in November 2022, seeking to reverse the drug's approval, reigniting a previously denied attempt from 2016.

Former FDA Commissioner Jane Henney, who oversaw the agency during mifepristone's initial approval, refutes claims that the drug's approval process was rushed. She acknowledges that the drug was approved under an accelerated process, but insists that safety was not compromised.

If judges can influence drug approvals, Fernandez Lynch warns that the pharmaceutical industry may avoid investing in controversial drugs that could lead to legal challenges. Henney also expresses disappointment in the Texas ruling, as it not only creates confusion for those seeking abortion care but also undermines the FDA's "gold standard" process, which holds significant influence in the U.S. and globally.