Federal Judge Suspends FDA Abortion Pill Approval, Gives Biden Administration Time to Appeal

On March 15, 2023, abortion rights advocates will gather in Amarillo Texas in front of J Marvin Jones Federal Building & Courthouse.

In 2000, the FDA approved mifepristone. Kacsmaryk supported nearly all the plaintiffs' arguments regarding their right to sue. They called for the FDA's approval for the drug to be removed. Kacsmaryk wrote that "the Court does not second guess FDA's decisions lightly." U.S. attorney general Merrick Garland stated that Kacsmaryk’s decision in Texas “overturns FDA’s expert judgement, rendered more than two decades ago, stating that mifepristone was safe and effective." The case will be heard by the U.S. 5th Circuit Court of Appeals. Kacsmaryk’s decision won't affect misoprostol access, which is used in other countries as a standalone drug for abortion. In November, a coalition of doctors opposed to abortion named the Alliance for Hippocratic Medicine filed a lawsuit against the FDA over the approval of mifepristone. Attorneys from the Alliance Defending Freedom represented the anti-abortion doctors. This organization worked with Mississippi legislators to draft the law that was at the heart of Dobbs v. Jackson Women's Health Organization. In its response to the lawsuit in January, the FDA described the case as "extraordinary and unheard of". The agency also stated that mifepristone had not been approved for an accelerated pathway. Lawyers at the FDA wrote that mifepristone was approved by the FDA as a safe, effective way to end an early pregnancy. This decision was based on a large amount of scientific evidence. The FDA warned women that removing mifepristone would endanger their health if they could not access the pill for safely ending pregnancies. Since its approval in 2000, Mifepristone is subject to FDA regulations to monitor the drug's efficacy and safety. As more and better evidence became available, the FDA began to ease the restrictions placed on mifepristone. The FDA dropped the previous rule that required medical professionals to visit patients in person, allowing for the delivery of the pill by mail. The World Health Organization recommends misoprostol as a method of abortion that can be used without mifepristone. According to the organization
.