Access to Abortion Drug is Threatened in Lawsuit

Image via REUTERS

Image via REUTERS

A Texas lawsuit concerning the FDA approval of an abortion drug is threatening to restrict its use across the country. The case was brought by The Alliance for Hippocratic Medicine, an anti abortion group, against the U.S. Food and Drug Administration (FDA).


Mifepristone is a drug most commonly used to perform abortions up to the 10th week of pregnancy. It works by blocking pregnancy hormones, which causes the lining of the uterus to break down, preventing further development. After the lining has broken down, a drug called misoprostol is used to remove the pregnancy tissue from the uterus. These drugs, when paired together, make up half of all abortions in the United States. If this case does end up blocking the use of mifepristone, it is possible for misoprostol to be used on its own to induce abortions, but is less effective than when the pair of drugs is used. 


The case was brought by an anti-abortion group called the Alliance for Hippocratic Medicine, who are asking for a preliminary injunction to block or suspend FDA approval of mifepristone. The Alliance for Hippocratic Medicine is a group of anti-abortion doctors, who were represented in court by a Christian legal group called the Alliance Defending Freedom. The Alliance’s arguments centered around the idea that the FDA’s approval process for mifepristone was unlawful; they claim the accelerated approval process that was applied to the drug should not have been used, since it is only supposed to be for medications that could help with “serious or life-threatening diseases,” and pregnancy is not a disease. They also made claims that the conditions under which the FDA tested the drug do not match the conditions under which mifepristone is prescribed, which the FDA’s lawyers said were factually inaccurate. Additionally, the FDA’s lawyers said that though the drug was under accelerated approval, it still took four years to get approved which means that the process itself was not accelerated. They also responded to the argument that pregnancy is not a disease by saying that, though pregnancy is not a disease, it is still a very serious medical condition that could potentially be deadly for the pregnant person. 

The Judge deciding this case, Judge Matthew Kacsmaryk, was appointed to a U.S. District Court by former president Donald Trump in 2019.  Some have raised questions about Kacsymaryk’s biases in relation to this case, with one Washington Post article claiming that the judge has been “shaped by his deep anti abortion beliefs”. Many sources have said that it seemed as though Kacsmaryk was considering ruling in favor of disrupting the FDA’s approval of the drug, though the judge did not say anything about what the likely outcome of his ruling would be. Kacsmaryk said that he would make his ruling “as soon as possible”. 


The judge’s decision will undoubtedly have a huge effect on the state of abortion access in the nation, since around ½ of abortions in the U.S. are done using medication like mifepristone. If he does end up blocking the FDA’s approval, many pregnant people seeking abortions will have to consider different options for the pregnancy. Whatever the outcome of this case is, one side of the debate over the controversial topic will inevitably be upset, provoking more discourse around American abortion rights.