Texas Federal Judge Hears Case that Could Force a Major Abortion Pill Off Market

In a case heard by federal Judge Matthew Kacsmaryk in Amarillo, Texas, Wednesday, it was argued whether or not the FDA was wrong to approve a drug that is used in almost all medicated abortions in the United States, and whether the drug, mifepristone, should be removed from the market. 

If the lawsuit succeeds, it may have wide-ranging repercussions for patients and abortion providers across the nation and the drug-approval process utilized by the FDA. As many as 25 states have filed amicus briefs in the crucial case. 

In November, a coalition of anti-abortion doctors and medical groups called the Alliance for Hippocratic Medicine sued the FDA, saying mifepristone, used in the abortion pill, was improperly approved two decades ago. The medication is part of a two-drug protocol to terminate pregnancies in the first trimester. 

Justice Department attorneys argued on the side of the FDA at the hearing on Wednesday, along with the drug company Danco, which manufactures mifepristone. 

Judge Kacsmaryk could now decide the case at any time. 

The plaintiffs have filed a motion to seek a preliminary injunction to remove the drug from the market in the United States or limit its availability. The FDA requested that the judge deny the motion and said the lawsuit was unlikely to succeed. 

The proceeding Wednesday was a hearing on the injunction motion, during which each side had two hours to present their arguments. 

Around five million people have used mifepristone since it was first approved in 2000. Medical groups maintain it has a strong safety record. The drug essentially induces a miscarriage and can be accompanied by complications. 

An attorney representing Alliance for Hippocratic Medicine, Erin Hawley, argued that the group’sgroup’s physicians have had to treat patients who have sometimes experienced severe complications, including heavy bleeding. Doctors have sometimes been forced to complete the abortion by performing a surgical procedure, despite deeply held beliefs. 

An attorney from Danco responded to Hawley, saying, “all drugs have side effects,” and maintained that treating those patients is a normal part of being a medical professional.

Attorneys spar over abortion drug’s original approval

The FDA approved the drug after “a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.”

Alliance for Hippocratic Medicine lawyers argued that the FDA’s approval depended on an ambiguous regulation for drugs used to treat serious illnesses. 

“Pregnancy is not an illness,” said attorney Erik Baptist, arguing that mifepristone was not appropriately approved. 

Lawyers for the FDA defended its use, countering that pregnancy can become life-threatening for some patients, and maintained that regardless of whether a pregnancy is described as an illness or condition, the wording is not relevant in terms of if the drug is safe or not. 

Julie Straus Harris, a lawyer for the Justice Department, pointed out that taking the drug off the market would cause harm to patients who rely on the drug and that it has been used for decades. 

Judge Kacsmaryk has several options, from restoring rules around mifepristone that the Biden administration and FDA have eased to leaving the drug on the market. Recent changes include allowing the medication to be dispensed by retail pharmacies or be mailed. In 2016, the agency decided that mifepristone could be used in the first ten weeks of pregnancy, which was raised from seven weeks.