In a massive victory for the pro-life movement, a federal judge has blocked the U.S. Food and Drug Administration’s (FDA’s) approval of mifepristone, one of the two drugs used in a chemical abortion.

In the ruling, handed down late on Good Friday, April 7, 2023, U.S. District Judge Matthew Kacsmaryk stayed the FDA’s Sept. 28, 2000, approval of mifepristone.

The lawsuit against the FDA was filed by attorneys with Alliance Defending Freedom (ADF) on behalf of four medical groups and four doctors, who allege that the FDA violated the law when it originally approved mifepristone.

According to ADF, the lawsuit is “the first to challenge federal government officials for their illegal approval of chemical abortions drugs that harm women and girls.”

Now, you may be wondering why it took nearly 23 years (the lawsuit was initially filed in November 2022) for a group to challenge the FDA’s approval of mifepristone.

Judge Kacsmaryk addressed that question in the first page of his 67-page ruling.

He wrote:

Over twenty years ago, the United States Food and Drug Administration approved chemical abortion … Why did it take two decades for judicial review in federal court?

Simply put, FDA stonewalled judicial review – until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within ‘180 days of receipt of the petition.’ … Had FDA responded to the Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinate for nearly 6,000 days (emphasis in original).

In 2000, the FDA approved mifepristone under its Subpart H regulation, titled “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses,” which applies to drugs that treat “serious or life-threatening illnesses.”

However, as Judge Kacsmaryk pointed out in his ruling, “Pregnancy is not an ‘Illness.’”

“Pregnancy is a normal physiological state most women experience one or more times during their childbearing years – a natural process essential to perpetuating human life,” the judge said.

In concluding his opinion, Judge Kacsmaryk wrote:

FDA’s approval of mifepristone is hereby STAYED.

Judge Kacsmaryk’s order will go into effect seven days from the initial ruling, allowing the Biden administration time to appeal. But should the ruling take effect, the abortion pill would be blocked for sale across the United States.

In a statement to the Daily Citizen, Robyn Chambers, Vice President of Advocacy for Children, called the ruling a “victory for women and their health!” She added:

I believe women deserve the best care possible for any medical procedure and there is no better care for women than a face-to-face meeting with a medical professional that can give her accurate medical information before any invasive procedure. Bypassing medical standards and putting women at risk is not true women’s health care.

Judge Kacsmaryk was appointed by former President Donald Trump to the U.S. District Court for the Northern District of Texas in 2017 and was confirmed to the court in 2019. He formerly served as deputy general counsel for First Liberty Institute, the largest non-profit legal organization dedicated exclusively to defending religious liberty.

“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,” said ADF Senior Counsel Erik Baptist after the ruling.

Baptist added:

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 or to 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.

A chemical abortion involves two drugs, mifepristone and misoprostol, which are usually taken 48 hours apart. Mifepristone blocks the pregnancy hormone progesterone, which preborn babies need to grow and survive. Subsequently, misoprostol then causes uterine contractions and a forced early miscarriage.

The abortion pill is now the most common method of abortion in the United States, with at least 54% of abortion done via “medication” abortion, according to the pro-abortion Guttmacher Institute.

On the same day that Judge Kacsmaryk handed down his ruling, Attorney General Merrick Garland issued a statement saying that the U.S. Department of Justice (DOJ) would appeal it.

“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” the attorney general said. “The Department will continue to defend the FDA’s decision.”

The DOJ is appealing the ruling to the U.S. Court of Appeals for the Fifth Circuit, which is one of the more conservative of the thirteen federal appellate courts. The fifth circuit currently has twelve judges appointed by Republican presidents and four appointed by Democrat ones.

Making the ongoing legal proceedings more complicated, a different U.S. district court judge – Judge Tomas Rice – issued a 31-page ruling mandating that the FDA keep mifepristone available in 18 states.

According to Ed Whelan, Vice President of the Ethics & Public Policy Center and former law clerk to Supreme Court Justice Antonin Scalia, Judge Kacsmaryk’s ruling is likely to override the ruling from Judge Rice.

“My initial read is that the rulings don’t conflict and that the Texas ruling would instead render the Washington ruling irrelevant,” Whelan said.

Either way, the conflicting rulings make it highly likely that the U.S. Supreme Court will get involved to clarify the law upon appeal.

But make no mistake, Judge Kacsmaryk’s ruling (and ADF’s lawsuit) is a courageous act of fortitude. Should the ruling take effect, the most likely result is that thousands of innocent preborn babies will be spared every year.

The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

Some women, after taking the first abortion pill (mifepristone) come to regret their decision. Thankfully, there is a way to reverse the pill’s effects if prompt action is taken.

To learn more about the abortion pill reversal protocol, visit or call 1-877-558-0333 to be connected with a medical professional who can guide callers through the process of reversing the pill’s effects.

Additionally, if you’re struggling and need a listening ear, Focus on the Family offers a free, one-time counseling consultation with a licensed or pastoral counselor. To request a counseling consultation, call 1-855-771-HELP (4357) or fill out our Counseling Consultation Request Form.

Related articles:

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New Lawsuit Alleges FDA’s Approval of Chemical Abortions Violated the Law

Pro-Life House and Senate Members Introduce Bills to Stop FDA Chemical Abortion Rule

Here’s the Secret Pro-Abortion Activists Won’t Tell You About the Abortion Pill: It’s Dangerous

More than Half of All Abortions are Now Done with the Abortion Pill, Study Finds

FDA Will Permanently Allow Abortion Pills by Mail. Women Deserve Better.

Complications from the Abortion Pill(s)

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