AMARILLO, Texas (KAMR/KCIT) — Saturday’s expected protests stem from a lawsuit filed late last year in Amarillo Federal Court which could impact abortion rights not only in Texas but throughout the United States.

In late 2022, the Alliance for Hippocratic Medicine, an Amarillo nonprofit organization, filed a lawsuit with a group of doctors and other associations, against the United States Food and Drug Administration surrounding the use of Mifepristone and Misoprostol for chemical abortions.

In the lawsuit, filed on Nov. 18, 2022 in the United States District Court for the Northern District of Texas Amarillo Division, the plaintiffs are asking that Matthew J. Kacsmaryk suspend the FDA’s approval of chemical abortion drugs and/or put back in place safeguards for the individuals who take this drug that they claim were taken away.

“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,” the complaint reads. “And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.” 

Who is a part of the lawsuit?

The Alliance for Hippocratic Medicine describes itself as a nonprofit organization that “upholds and promotes the fundamental principles of Hippocratic medicine: protecting the vulnerable at the beginning and end of life; seeking the ultimate good for the patient with compassion and moral integrity; and providing health care with the highest standards of excellence based on medical science.”

Members of the nonprofit include other plaintiffs in the lawsuit including the American Association of Pro-Life Obstetricians and Gynecologists, Christian Medical and Dental Associations and the American College of Pediatricians.

One of the doctors included as a plaintiff in this lawsuit is Shaun Jester, a doctor in the Dumas area who is listed in the lawsuit as the medical director of the Moore County OB/GYN.

The plaintiffs are bringing the lawsuit against the U.S. FDA, along with Robert Califf, the commissioner of food and drugs for the FDA and other officials within the FDA and the U.S. Department of Health and Human Services.

What is the drug that the lawsuit centers around?

According to the FDA’s website, Mifepresetone is approved in a regimen with Misoprostol to end an “intrauterine pregnancy through ten weeks gestation.” The FDA first approved the drug in 2000 and approved a more generic version of the drug in 2019.

Mifepristone is required to be “dispensed by, or under the supervision of, a certified prescriber or by certified pharmacies.” It can be dispensed in person or by mail.

What does the lawsuit say?

The claims that the plaintiffs have made in this lawsuit is that the FDA never had the authority in 2000 to approve these drugs for sale, ultimately rushing the drug through the process.

They also claim that while the drug has been on the market, the FDA has eliminated safeguards it previously established to protect those who go through the regimen. The plaintiffs reference changes in 2016 where various items changed, including the dosage, the decreased number of required in-person office visits along with changes to the people who could prescribe and administer the drugs.

“After two decades of engaging the FDA to no avail, Plaintiffs now ask this Court to do what the FDA was and is legally required to do,” the complaint reads, “protect women and girls by holding unlawful, setting aside and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen.”

What have people said about this lawsuit’s potential impact?

At its core, Julie Marie Blake, the senior counsel with Alliance Defending Freedom who is involved with the plaintiffs in the lawsuit, said the lawsuit is centered around removing the drugs from the market, or “at a minimum,” ordering the FDA to restore important safeguards for the use of the drugs.

“These drugs are dangerous, they should never have been approved in the first place,” she said. “The FDA never had the studies to show they were safe and the FDA never had the legal authority to allow them on the market or to remove safeguards… If our lawsuit succeeds, women and girls across the country will be protected from dangerous chemical abortion drugs.”

Rachel O’Leary Carmona, the executive director of the Women’s March, said she believes that the lawsuit should be thrown out for having no basis in law or fact.

“My hope would be that people understand, right now, and understand what our opponents are exactly trying to do in this moment, which is override the will of the people,” she said. “The people have spoken. The people spoke at the ballot box… and then the Dobbs decision itself was that 70% of American people did not support it.”

Carmona said if this lawsuit went through, it would ultimately impact abortion access “drastically” throughout the United States.

“What that means is that states that have protected abortion access do not have access to this drug from the market itself,” Carmona said if the lawsuit ends up not going in their favor. “So, even if you live in a state that doesn’t have an abortion ban, or if you live in a state that has enshrined reproductive freedoms inside of a constitution or inside of legislation, it still means that you cannot access this drug.”

If the lawsuit is thrown out or does not go the plaintiffs’ way, Blake said she believes the drugs will continue to harm individuals.

“Chemical abortion drugs are dangerous,” she said. “One in five women who take chemical abortion drugs will suffer complications and seek medical attention… Our doctors, local OB’s, (and) local emergency room doctors stand in the gap to help care for these women when they suffer these complications. But chemical abortion drugs are dangerous and women and girls deserve better.”

What’s next?

Since the initial complaint, the plaintiffs have filed a motion for “preliminary injunction,” asking the court to rule that the FDA should withdraw or suspend its approval of the drug and, ultimately, take it off the market as the lawsuit continues.

The plaintiffs said that the judge should grant this motion because they are “likely to prevail on their claims,” with the FDA “running roughshod over the laws and regulations that govern the agency… (and) protect the public from harmful drugs,” according to a brief that accompanied the motion.

“The only way the FDA could have approved chemical abortion drugs was to call pregnancy an “illness” and argue that these dangerous drugs provide a “meaningful therapeutic benefit” over surgical abortions. Both of those conclusions are transparently false,” the brief reads. “What’s more, in approving these drugs, the FDA chose politics over science because the FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of this hormone-blocking regimen on the developing bodies of adolescent girls, and disregarded the substantial evidence that chemical abortions cause more complications than even surgical abortion” 

The defense argued that the plaintiffs’ claims are unlikely to succeed and will likely fail, stressing that the drugs have been on the market for more than 20 years.

“More than twenty-two years ago, the U.S. Food and Drug Administration (FDA) approved the drug mifepristone as safe and effective for the medical termination of intrauterine pregnancy under certain conditions,” the response brief reads. “In this unprecedented action, Plaintiffs ask this Court to upend that longstanding scientific determination based on speculative allegations of harm offered in support of claims and arguments that are untimely, unexhausted, and without merit.” 

The defense also argued that the plaintiffs will not suffer “imminent and irreparable harm” without a preliminary injunction, stating that the real harm will come from the individuals who need access to this treatment while “seismically” disrupting the FDA’s governing authority, according to another brief in favor of the defense.

“Entry of a preliminary injunction here would hardly serve the typical purpose of such relief—maintaining the status quo during the pendency of litigation,” the brief went on to say. “Rather, it would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution”

In an order filed Thursday, Kacsmaryk ruled that the replies surrounding the “preliminary injunction” motion can be made through Feb. 24. Briefing will then be closed on the matter. Since Thursday, a number of responses have been filed in Amarillo Federal Court on both sides.

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