U.S. District Judge stays U.S. FDA's approval of mifepristone after recent preliminary injunction hearing in Amarillo

AMARILLO, Texas (KAMR/KCIT) — United States District Judge Matthew J. Kacsmaryk of the Amarillo Federal Court ruled Friday that the United States Food and Drug Administration’s approval of mifepristone, a drug used for chemical abortions, will be stayed.

According to documents filed Friday afternoon in the U.S. District Court for the Northern District of Texas Amarillo Division, this order is expected to go through in seven days, on April 14, to “allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.”

This comes after a preliminary injunction hearing in March where Kacsmaryk heard from both sides, arguing whether or not he should suspend the approval of the treatment and/or put back safeguards surrounding the treatment of the plaintiffs, an Amarillo nonprofit organization called the Alliance for Hippocratic Medicine, allege was taken away.

How did we get here?

The nonprofit organization filed a lawsuit in Amarillo Federal Court in late 2022 against the U.S. FDA, challenging the group’s approval of mifepristone back in 2000. The group filed a motion for preliminary injunction in this case in November 2022.

According to previous reports by MyHighPlains.com, the nonprofit asked for Kacsmaryk to ultimately suspend the approval of the treatment, or put back safeguards the plaintiffs allege was taken away from the FDA. However, throughout the legal proceedings, the defendants, which include the FDA and Danco Laboratories, the distributor for mifepristone, continued to argue that the drug is effective and safe, just as when it was first approved for sale.

During a more than four-hour hearing back in March, the plaintiffs argued that women have suffered harm because of the treatment since its initial approval back in 2000. Erin Hawley, one of the attorneys representing the plaintiffs, said at the time that 5-8% of women who have used mifepristone for a chemical abortion needed the procedure completed through surgery.

The plaintiffs also alleged that the mailing of mifepristone violated the Comstock Act of 1873, stating that there is no consensus in courts throughout the United States and that it could result in a “sea change” for federal and state relations based on each state’s respective laws on abortion.

During the hearing, the defendants argued the timelines of the plaintiffs’ argument and argued that much of what the plaintiffs brought forward was not relevant.

Julie Straus Harris, a member of the defendant’s legal team, argued at the time that while the FDA said that the drug was safe and effective, the administration does not require individuals to take it and does not require individuals to prescribe it.

At the time, Straus Harris also said that any approval of an injunction would be extremely harmful to the public and ultimately undermine the “administrative framework” of the FDA.

Jessica Ellsworth, the attorney representing Danco Laboratories, stressed that this injunction would cause the company “irreparable harm,” as the distributor of mifepristone, stating that the treatment had a “consistent record of safety.”

What did Friday’s ruling say?

Ultimately, Kacsmaryk ruled that the plaintiffs in this case had a substantial likelihood of success surrounding their claims on the FDA’s approval of the drug. In Friday’s order, Kacsmaryk walks through each portion of the approval in detail, including the 2000 approval, the 2016 changes, the 2019 generic approval and the 2021 actions, stating why he believes that the plaintiffs have merit in the suit.

“Simply put, FDA stonewalled judicial review – until now,” Kacsmaryk said in the opinion. “Before Plaintiffs filed this case, FDA ignored their petitions for over 16 years, even though the law requires an agency response within “180 days of receipt of the petition.”

The American Association of Pro-Life Obstetricians and Gynecologists filed two petitions related to the FDA’s approval of mifepristone, one in 2002 and the other in 2019, both of which were denied by the FDA after significant time.

Kacsmaryk said that the plaintiffs have standing in this case for multiple reasons, stating that the FDA’s failure to require reporting of adverse events of the use of the drug has impacted the ability of doctors and medical associations to inform patients and the public about the dangers of chemical abortion drugs.

Kacsmaryk also specifically spoke about the Comstock Act in relation to the FDA’s 2021 decision to permit chemical abortion by mail. According to previous reports by MyHighPlains.com, the Comstock Act of 1873 specifically prohibits the mailing of chemical abortion drugs.

Kacsmaryk said that the 2021 action by the FDA specifically is in violation of that act, stressing that the plaintiffs’ challenges to the 2021 actions under the act have a “substantial likelihood of success on the merits.”

Kacsmaryk goes on to say that it is indisputable that chemical abortion drugs are both drugs and are for producing abortion, therefore violating federal criminal law if they are mailed. With people taking mifepristone without physician supervision, he said the plaintiffs have good reasons to believe that alleged injuries because of the drug could continue in the future, “possibly with greater frequency than in the past.”

“In any case, the Comstock Act plainly forecloses mail-order abortion in the present, and Defendants have stated no present or future intention of complying with the law,” he said.

Going back to the original 2000 approval, Kacsmaryk challenged the accelerated approval of mifepristone under subpart H of Title 21 of the Code of Federal Regulations. According to previous reports, that portion of the code gives accelerated approval for new drug products that were “studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefits to patients over existing treatments.”

As the plaintiffs said during the preliminary injunction hearing, Kacsmaryk echoed the sentiment that “pregnancy is not an illness” and ultimately unlike any other drug or treatment that was approved under subpart H, which included drugs treating HIV and HIV-related diseases, various cancer treatments and bacterial infections.

In the initial approval, Kacsmaryk also said that the FDA failed to consider the psychological effects of the drug, as well as long-term medical consequences, claiming that the FDA faced “significant political pressure (at the time) to advance increased access to chemical abortion.”

“Whether FDA abandoned its proposed restrictions because of political pressure or not, one thing is clear,” Kacsmaryk said, “the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions”

If the motion was not granted by Kacsmaryk, he said that the plaintiffs would have been likely to suffer irreparable harm, citing that two women died from chemical abortions in the past year. He also said that the decision would serve the public interest.

While the defendants would be harmed by an injunction, Kacsmaryk said that “the court still balances these factors in favor of ensuring that women and girls are protected from unnecessary harm and that Defendants do not disregard federal law.”

“Defendants are correct that one purpose of injunctive relief is to preserve the status quo… Chemical abortion is the only status quo insofar as Defendants’ unlawful actions and their delay in responding to Plaintiffs’ petitions have made it so,” Kacsmaryk said in the opinion. “The fact that injunctive relief could upset this ‘status quo’ is, therefore, an insufficient basis to deny injunctive relief.”

At the end of the order, Kacsmaryk stayed “the effective date” of FDA’s 2000 approval of mifepristone, “and all subsequent challenged actions related to that approval,” including the 2016 changes, the 2019 generic approval and the 2021 actions.

However, Kacsmaryk also stated in the ruling that the “applicability of this opinion and order” will be stayed for seven days “to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.”

Take a look at Kacsmaryk’s full ruling below:

MEMORANDUM OPINION AND ORDER Download

How are people responding to this ruling and what’s next?

In a statement provided by Erik Baptist, the counsel for Alliance Defending Freedom who represented the plaintiffs in the case, he said that Kacsmaryk’s ruling on the preliminary injunction protects the safety of women and girls.

“By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions. Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can pose serious and life-threatening complications to the mother, in addition to ending a baby’s life,” Baptist said. “The FDA never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”

In response to the ruling, Rachel O’Leary Carmona, executive director of Women’s March, claimed that a full nationwide ban on abortion and access to reproductive health care was the ultimate goal of Kacsmaryk and Alliance Defending Freedom.

“Within that context, Kacsmaryk’s frankly illegitimate decision to suspend the drug is not surprising,” she said. “This isn’t a case about science. The science is settled. Mifepristone has been used, studied and found to be completely safe and effective for abortion for more than 20 years. It is used by the majority of women who seek abortions as a private and safe option. It is for these exact reasons–because it gives women the ability to make decisions for themselves and their families–that the political right has been so intent on banning it. What this case is really about is how the ADF and their allies manipulated our judicial system to impose a radical anti-woman political agenda.”

On Friday, a federal judge in Washington ordered that authorities should not restrict access to mifepristone in 17 Democratic-led states. According to reports on MyHighPlains.com, this ultimately countered Kacsmaryk’s ruling, blocking the FDA from making any changes to the drug’s access in 17 states and the District of Columbia.

According to the documents obtained by MyHighPlains.com from the United States District Court for the Eastern District of Washington, the plaintiffs involved in this other lawsuit include: