The Blubber

On Friday, a Texas federal judge issued an order temporarily blocking the U.S. Food and Drug Administration's (FDA) authorization of the abortion medication mifepristone, creating a setback for supporters of abortion rights. The ruling comes in the context of the U.S. Supreme Court's recent decision to overturn the constitutional right to abortion.

In a detailed 67-page ruling, U.S. District Judge Matthew Kacsmaryk determined that the FDA's approval of mifepristone, which has been in place for over 20 years, contravened a federal regulation that permits expedited approval for specific drugs. He also found that subsequent actions taken by the FDA were illegal. Kacsmaryk, however, delayed the implementation of his ruling for seven days to provide the Biden administration with an opportunity to appeal to the U.S. Court of Appeals for the 5th Circuit.

The Biden administration responded by filing an appeal late on Friday night.

Attorney General Merrick Garland expressed the Justice Department's disagreement with the ruling in the case of Alliance for Hippocratic Medicine v. FDA. He stated that the department would appeal the decision and request a stay pending the appeal. Garland emphasized that the ruling contradicts the FDA's longstanding determination that mifepristone is both safe and effective.

Although Judge Kacsmaryk's injunction did not fully revoke or suspend the FDA's approval of mifepristone, as requested by some anti-abortion rights medical groups, it still has significant implications. Kacsmaryk, who was appointed by former President Donald Trump, could have caused widespread disruption to access to the medication for millions of women across the country, including in states where abortion is legal.

The ruling adds to the uncertainty surrounding abortion access in the U.S., especially after the Supreme Court's reversal of Roe v. Wade in June of the previous year. Following that decision, at least 12 states have implemented near-total abortion bans or imposed stricter regulations, undermining the right to abortion under the U.S. Constitution.

In a related development, a federal judge in Washington state issued a separate ruling in a different case involving mifepristone. This ruling provisionally prevented the Biden administration from making changes to the current availability of the medication. The conflicting rulings create a high-stakes legal conflict that could ultimately be resolved by the Supreme Court.

Mifepristone, which was approved by the FDA over two decades ago, is used in combination with another drug, misoprostol, to end pregnancies up to 10 weeks gestation. The FDA has made several modifications to the regulations governing the use of the abortion pill, including approving a generic form of mifepristone in 2019 and removing the in-person dispensing requirement in 2021, thereby enabling telemedicine prescriptions and mail delivery.

However, it was not until November of the previous year, 22 years after the FDA's initial approval, that a group of doctors and medical associations filed a lawsuit in the federal district court in Amarillo, Texas, seeking to reverse the FDA's approval of mifepristone. The case was assigned to Judge Kacsmaryk, the sole judge in that district.