Federal Judge Halts FDA Approval of Abortion Pill

A federal judge released a decision on Friday evening halting the U.S. Food and Drug Administration’s (FDA) 2000 approval of mifepristone, the first drug used in a two-drug abortion regimen.

U.S. District Judge Matthew Kacsmaryk issued a 67-page opinion stating that the FDA unlawfully approved mifepristone. The Trump-appointed judge put his decision on hold for seven days to allow the “federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.”

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

The Alliance Defending Freedom (ADF) filed a lawsuit in November of 2022 against the 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.” The lawsuit pointed to six discrete agency actions since the legalization of mifepristone and misoprostol in 2000, and asked the court to hold the agency’s actions unlawful. 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. 

Part of the ADF’s argument was 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 complaint states. 

Kacsmaryk wrote in his decision that at most, the FDA could have lawfully approved mifepristone “for cases where a pregnant woman’s life or health is in danger,” but “even a limited approval of this sort would still not render pregnancy an ‘illness.”‘

“And surgical abortion — a statistically far safer procedure — would still be available to her. But in any case, that is not what FDA did. Instead, FDA manipulated and misconstrued the text…to greenlight elective chemical abortions on a wide scale. Therefore, Plaintiffs have a substantial likelihood of prevailing on their claim that Defendants violated [the law],” he continued. 

The judge rebuffed the FDA’s argument that approval of the abortion pill should remain because unaborted children of the women “who seek but are unable to obtain an abortion” are “expected to do worse in school,” “to have more behavioral and social issues, and ultimately to attain lower levels of completed education,” and to have “lower earnings as adults, poorer health, and an increased likelihood of criminal involvement.” 

“But using abortion to promote eugenic goals is morally and prudentially debatable,” he wrote. “Though eugenics were once fashionable in the Commanding Heights and High Court, they hold less purchase after the conflict, carnage, and casualties of the last century revealed the bloody consequences of Social Darwinism practiced by would-be Übermenschen.” 

Kacsmaryk added that the  “FDA stonewalled judicial review — until now,” and said the agency had ignored petitions against its approval of mifepristone for 16 years. 

BREAKING🚨 Federal court ruled to halt the @US_FDA's approval of chemical abortion drugs.

This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.

— Alliance Defending Freedom (@ADFLegal) April 7, 2023

The ADF issued a statement on Friday night calling the decision a “significant victory.”

“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,” Alliance Defending Freedom Senior Counsel Erik Baptist said. 

He continued: 

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. 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.

Today’s decision challenging the FDA's decades-long approval of mifepristone exposes how far anti-abortion activists will go to further restrict abortion nationwide.

We should be enraged that approval of a safe and effective abortion method could be overruled by ONE judge.

— Alexis McGill Johnson (@alexismcgill) April 7, 2023

President of the abortion giant Planned Parenthood, Alexis McGill Johnson, tweeted  that “we should be enraged” by the judge’s decision to halt the approval of the abortion pill.

“Today’s decision challenging the FDA’s decades-long approval of mifepristone exposes how far anti-abortion activists will go to further restrict abortion nationwide. We should be enraged that approval of a safe and effective abortion method could be overruled by ONE judge,” Johnson wrote.

SBA Pro-Life America’s State Policy Director Katie Glenn released a statement via email, calling the decision a “win for the health and safety of women and girls.” 

“The ruling reaffirms that pregnancy is not an illness and abortion is not health care. Finally, the FDA is being held accountable for its egregious violation of its own rules to fast-track dangerous abortion drugs to market,” Glenn said. “The abortion drug regimen rubber-stamped by the FDA has proven disastrous for women as well as unborn children, with the FDA’s own data showing women have died. The Biden FDA ignored the science and approved abortion drugs for sale by mail-order, without any in-person doctor visit, which the strong majority of Americans oppose.” 

Less than an hour after Kacsmaryk’s ruling, a federal judge out of Washington State issued a contradictory decision ordering the FDA to make no changes to the availability of mifepristone.

“The decision by Judge Kacsmaryk is an important victory for the rule of law,” Breitbart News senior legal contributor Ken Klukowski said in reaction to the decision from Texas. “The fact that multiple federal courts are going in opposite directions could quickly lead to what is called a circuit split at the appeals court level, which would likely send this issue to the Supreme Court within a year.”

SBA Pro-Life America pointed to polling it released on Friday showing that “Americans do not believe the FDA’s assertions that mail-order abortion drugs are safe – including 75 percent who agree the FDA should have performed studies focused on girls under the age of 18 before approving the abortion pill for minors.” The poll additionally found that 62 percent do not feel very confident “in the claim that the abortion pill is safe after being on the market for two decades, when they know that the FDA tracks no side effects other than death.”

“[Sixty-one percent] disagree that it is safe to distribute abortion pills through the mail with little to no supervision (41 percent strongly disagree), in light of the increased risk to women of coercion and abuse,” according to the organization.  “Fifty-six percent] consider the FDA untrustworthy (31 percent very untrustworthy) when they learn that the FDA fast-tracked the abortion pill regimen using its accelerated drug approval authority by calling pregnancy a ‘life-threatening illness.”’

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 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.