FDA Fights Against Abortion Pill Lawsuit

Lucia Hogan, Student Writer

A picture of Mifeprex (Mifepristone)
A picture of Mifeprex (Mifepristone), commonly used to induce abortions. (Photo by ROBYN BECK/AFP via Getty Images)

Back in the November of 2022, the conservative law group Alliance Defending Freedom (ADF) filled a lawsuit against the FDA for its approval of the drug Mifepristone in Amarillo, Texas. Mifepristone is one of two of the main drugs used to induce abortions, the other called misoprostol.

The ADF claimed in their lawsuit that the FDA’s approval of the drug back in 2000 was fast-tracked by classifying a pregnancy as an illness and that the side-effects of the drug were not fully explored. The consequence of this being that it caused irreparable harm to women and girls and, by keeping the approval in place, it will continue to fail them.

The exact words in the suit being…

“The U.S. Food and Drug Administration (FDA) must protect the health, safety, and welfare of all Americans by rejecting or limiting the use of dangerous drugs.

But the FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

The FDA attorneys defended by stating that by siding with the ADF, the judge presiding over the case will be undoing “…longstanding scientific determination based on speculative allegations of harm…” The attorneys also state that by going through with the lawsuit that it could put many people and businesses at risk due to how the drug is distributed in the first place. This is because mifepristone needs to be taken with the previously mentioned misoprostol in order to induce an abortion.

On its own, mifepristone just blocks the development of progestogen and it is often used in the treating and managing of uterine leiomyomas and Cushing’s syndrome. The former being growths of uterine muscles growing on the outside of the uterus and the latter being the result of too much cortisol in the body, which leads to type 2 diabetes, blood clots in the legs, and heart attacks/strokes if left unchecked. It is highly regulated and is extremely difficult to get ahold of, to the point that most people don’t know that it exists.

Another entity has also the entered the lawsuit: Danco Laboratories. They are the makers of the brand-named option of Mifepristone and they filed a motion to intervene on January 13. Their case is derived from how, if the lawsuit continues and ends in the favor of ADF, it will deprive the company of explicit federal approval to continue the production of Mifeprex.

This lawsuit has also brought in the American College of Obstetrics and Gynecology on the side of the FDA because they also disagree with the statement that the drug causes harm at the rate the ADF purports. The studies conducted by the college have shown that it is one of the safest drugs for its intended use and has sent less people into urgent care than both Tylenol and Viagra.

The judge presiding of the case is Matthew Kacsmaryk, a Trump-appointed federal judge.

As of writing, there is no word on the verdict yet.