As soon as Friday, a district judge could issue a ruling potentially blocking the use of the abortion medication mifepristone across the United States.
The Alliance Defending Freedom (ADF) filed a lawsuit in November of 2022 against the U.S. Food and Drug Administration (FDA) on behalf of four national medical associations and several doctors, alleging that the agency “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 complaint states.
For context, mifepristone is the first of two drugs used in a drug-induced abortion. According to former abortionist Dr. Anthony Levatino, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
The pro-abortion Guttmacher Institute found that mifepristone is used for more than half of all abortions in the United States. In 2020, the drug accounted for 53 percent of all abortions, up from 39 percent in 2017.
The lawsuit points to six discrete agency actions since the legalization of mifepristone and misoprostol in 2000, and asks the court to hold the actions unlawful, which would ultimately take mifepristone off the market. The ADF filed the lawsuit in the U.S. District Court for the Northern District of Texas, and called the lawsuit the first of its kind.
The complaint details how former President Bill Clinton, on his second full day in office in January of 1993, directed his cabinet to legalize chemical abortion drugs in the United States. The complaint alleges:
President Clinton and his agency officials then pressured the French manufacturer of the key chemical abortion drug, mifepristone, to donate for free the U.S. patent rights of the drug to the Population Council—as its name suggests, an entity focused on population control. After receiving the patent rights to mifepristone, the Population Council submitted a new drug application, worked closely with the Clinton FDA during the review process, and, not surprisingly, obtained the agency’s approval September 28, 2000—just over one month before the closely contested 2000 U.S. presidential election.
The complaint then states that the “only way” the agency could have approved chemical abortion drugs “was to use its accelerated drug approval authority, necessitating that FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments.”
“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs,” the ADF argues.
The ADF further alleges that the FDA never studied the safety of mifepristone under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded evidence that chemical abortion drugs cause more complications than surgical abortion, and eliminated necessary safeguards for pregnant girls and women who take the regimen.
The lawsuit then details how, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take the abortion drugs —from seven weeks gestation to ten weeks gestation. Then in 2019, the FDA allegedly approved a generic version of the drug “without requiring any new clinical investigations or studies that evaluated the drug’s safety and effectiveness under the requirements” under several laws, according to the complaint.
In 2021, the FDA then allowed abortionists to send mifepristone through the mail, which the ADF says was “in direct violation of federal law.” The FDA recently made permanent its rule to allow women and girls to receive a prescription for mifepristone via telemedicine. The complaint alleges:
All of the FDA’s actions on chemical abortion drugs—the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement—failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier. Instead, the FDA’s actions permitted and sometimes even encouraged these illegal activities.
Additionally, the complaint alleges how, despite major changes to the regiment throughout the decades, the FDA “eliminated the requirement for prescribers to report all nonfatal serious adverse events from chemical abortion drugs.”
“The FDA’s decision not to require abortionists to report all adverse events for chemical abortion drugs harms women and girls because it creates an inaccurate and false safety profile for the use of chemical abortion drugs,” the complaint alleges.
The complaint continues:
Due to inadequate adverse event reporting, the true rates of risks associated with chemical abortion drugs remain undercounted and therefore are unknown. Because abortion providers cannot know the accurate risk levels that their patients face when ingesting these drugs, these providers cannot properly inform their patients about the risks associated with chemical abortion. This prevents women and girls from giving informed consent to these providers. Many women and girls do not fully understand the nature of chemical abortion drugs and the risks that these drugs present to them.
The lawsuit also notes that the FDA:
…eliminated all procedural safeguards that would rule out ectopic pregnancies, verify gestational age, identify any contraindications to prescribing mifepristone, or identify potential complications like sepsis and hemorrhage, remaining fetal parts, and others until the patient is at a critical time or it is too late to help the patient.
“As a result, women and girls often suffer unexpected episodes of heavy bleeding or severe pain and must rush to the emergency department of the nearest hospital,” the complaint states.
The FDA filed in opposition to the motion for preliminary injunction on January 13, 2023, calling plaintiffs’ request “extraordinary and unprecedented.” The reply reads:
Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market—much less an example that includes a two-decade delay. Nor have Plaintiffs identified any instance in which a court has entered a preliminary injunction suspending or withdrawing approval of a widely available drug on any other ground.
The FDA claims that the issuance of a preliminary injunction would “cause significant harm” and deprive patients of “a safe and effective drug that has been on the market for more than two decades.” The agency argues:
Entry of a preliminary injunction here would hardly serve the typical purpose of such relief—maintaining the status quo during the pendency of litigation. 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. The balance of the equities and the public interest thus also strongly favor denial of Plaintiffs’ motion.
Kirsten Moore, director of the EMAA Project, which works to expand access to medication abortion, told ABC News that a ruling in favor of the ADF and pro-life doctors “would be devastating.”
“This would be taking an FDA approved drug off the market for no public health reason,” Moore claimed.
ADF Senior Counsel Erik Baptist said taking “dangerous chemical abortion drugs” off of the market would better protect women and girls.
“The FDA’s approval of chemical abortion drugs has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable girls and women,” Baptist said, adding:
On behalf of the national health care organizations and physicians we represent, we ask the court to hold the FDA accountable for its reckless, unlawful behavior. We urge the court to reject the marketing and distribution of dangerous chemical abortion drugs so that the health, safety, and welfare of women are protected.
The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-cv-223 in the U.S. District Court for the Northern District of Texas.