U.S. District Court Judge Rules FDA
Wrongly Approved Chemical Abortion Pill

Dear Friends,

Our prayers were answered on Good Friday evening with a huge victory for Life. Judge Matthew Kacsmaryk, a Federal District Court Judge in Amarillo, Texas, released a ruling that the FDA made a series of legal errors and wrongly approved the chemical abortion pill drug Mifepristone.

Judge Kacsmaryk stayed the applicability of his opinion and order for seven days to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit. If enacted, Judge Kacsmaryk’s ruling could put a hold on the sale and distribution of chemical abortion pills nationwide. Chemical abortions, also called medication abortions, account for 54% of all abortions in the U.S. — a dramatic increase from only 6% of abortions 20 years ago.

The Biden Administration immediately filed a Notice of Appeal to the Fifth Circuit last Friday evening. Ultimately, the case could reach the Supreme Court of the United States.

The Lawsuit | Judge Kacsmaryk’s Ruling

As Council for Life reported last month, the high-stakes Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration is the biggest abortion related case since the Dobbs decision eleven months ago. Judge Kacsmaryk heard oral arguments on March 15.

Alliance Defending Freedom (ADF) filed the lawsuit last November on behalf of several pro-life groups and physicians. The lawsuit challenges the FDA’s approval of Mifepristone two decades ago under the Clinton Administration and the FDA’s later expansion of the deadly drug under the Obama and Biden administrations. 

As set forth in his 67-Page Opinion, Judge Kacsmaryk generally agreed with the Plaintiffs on their major points, among them including:

FDA Did Not Adequately Review Mifepristone’s Safety

In questioning the FDA’s decision to approve Mifepristone, Judge Kacsmaryk wrote, “The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” 

FDA’s Loosening of Restrictions Over the Years

Judge Kacsmaryk was highly critical of the FDA’s repeated, significant departures over the years from its original regulatory safeguards on how the pill is distributed and administered. He faulted the FDA for “lax reporting requirements” writing the FDA “took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls.”

Most recently under the Biden Administration, the FDA has expanded the reach of the life-destroying drugs even further by allowing abortion drugs to be sold through the mail without any direct medical supervision and by Walgreens, CVS, RiteAid and other pharmacies

Individual Injustice and Irreparable Injury

Judge Kacsmaryk cited Plaintiffs’ allegations of “many intense side effects” and “significant complications requiring medical attention” resulting from chemical abortion pills. He noted, “Many women also experience intense psychological trauma and post-traumatic stress from excessive bleeding and from seeing the remains of their aborted children.”

Pregnancy is Not an Illness

Judge Kacsmaryk also found that the FDA was wrong in approving Mifepristone using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The Judge rejected FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”

Comstock Act

Judge Kacsmaryk also agreed with Plaintiffs in invoking the Comstock Act, a federal law that prohibits the mailing of “[e]very article or thing designed, adapted, or intended for producing abortion…” and, therefore, the mailing of chemical abortion pills.

A Simultaneous Second Contradictory Ruling
by a Federal Judge in Washington State

Separately on Friday within minutes of the Texas ruling, a District Court Judge in Washington State, Judge Thomas O. Rice, issued a ruling that stands in direct conflict. Judge Rice’s ruling could prevent the FDA from limiting access and distribution of the pill in at least 17 states and the District of Columbia that brought suit against the FDA to preserve access. Judge Rice did not order the FDA to roll back any of its restrictions of Mifepristone in his Friday ruling, but instead ruled that the status quo must remain.

While the Washington case is more limited in scope, the dueling rulings present a great deal of uncertainty. As observed by Glenn Cohen of Harvard Law School, “FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of Mifepristone.”

Let’s Revisit:
What is Mifepristone?
What are the Dangers of Chemical Abortion?

Mifepristone is the chemical abortion drug approved by the FDA in 2000 to terminate the life of an unborn baby. In a chemical abortion, Mifepristone blocks the natural hormone progesterone, causing the developing baby to die from lack of vital nutrients. A second drug Misoprostol is then taken to induce powerful uterine contractions to expel the deceased baby from the womb.Clinics and doctors that prescribe the two-drug combination have said that if Mifepristone is pulled from the market, they will shift to using only Misoprostol for abortions. 

Dangerous complications from chemical abortions occur at a much higher rate than surgical abortions, including incomplete abortion, septic shock, future miscarriage and stillbirth, excessive bleeding, and hemorrhaging and death from undiagnosed ectopic pregnancy.

Investment in the manufacture and distribution of the chemical abortion drug since its earliest days in the U.S. over twenty years ago has proven quite lucrative for investors.

Biden Administration Highly Critical
of Judge Kacsmaryk’s Order

Judge Kacsmaryk’s ruling has been decried by the Biden Administration and Democrat lawmakers. Attorney General Merrick Garland stated, “Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that Mifepristone is safe and effective.” Representative Alexandria Ocasio-Cortez went so far as to say his ruling should be ignored.

Continue to Pray for the Protection of Judge Kacsmaryk and Others in Positions of Authority

Judge Kacsmaryk has received death threats, harassing phone calls and protests in connection with the case. As this case and others involving abortion pills and rights make their way through the courts, please continue to pray for him, other judges and those in positions of authority who boldly and courageously defend the unborn.

Suzanne Everbach
Director of Communication and Philanthropy
Council for Life