Federal Judge Rules to Reverse FDA Approval of Abortion Pill

On Friday, April 7, 2023, a federal judge in Texas ruled to reverse the approval of mifepristone, the abortion pill. The Trump-appointed judge, Mathew Kacsmaryk, was assigned to the Alliance for Hippocratic Medicine v. United States FDA case, filed on January 13, 2023. Although no decision was made public until last week, many predicted the judgment based on Kacsmaryk’s political affiliations and previous ruling.

Kacsmaryk’s ruling was a preliminary injunction, deeming the FDA approval of mifepristone in 2000 invalid. The case marks the first lawsuit where a judge decided to overrule FDA approval. If the ruling is enforced, the entire nation will be unable to access mifepristone, the most common abortion method.

Many people, including healthcare professionals and legal experts, have vehemently opposed this ruling, deeming it unsafe or unjust. Legal analyses have determined that judges do not have the authority to overrule FDA decisions on drug approvals and market availability; however, further litigation will likely be required before the decision is reversed.

While this ruling in Texas took place, another order out west attempted to bolster access to abortion care. Judge Thomas O. Rice of the Eastern District of Washington determined that access to abortion pills must remain available in 17 states and Washington, DC, without additional restrictions.

The two preliminary injunctions directly contradict one another, leaving many people to speculate that litigations on the abortion pill will reach the US Supreme Court. After the supreme court’s 2022 decision to overturn Roe v. Wade in the Dobbs v. Jackson case, it is unclear where the decision will stand.

Following the Texas ruling, the US Department of Justice announced its disdain for it, noting that it strongly disagreed with the decision. Additionally, the organization announced plans to review both legal decisions and take action to protect reproductive freedom.

“My Administration will fight this ruling. The Department of Justice has already filed an appeal and will seek an immediate stay of the decision. But let’s be clear ­ the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe v. Wade,” President Biden said in his statement on the Texas decision. “Vice President Harris and I will continue to lead the fight to protect a woman’s right to an abortion and to make her own decisions about her own health. That is our commitment.”