By: Ryan Mills –nationalreview.com – April 7, 2023

A federal judge in Texas has suspended the Food and Drug Administration’s approval of the abortion pill mifepristone.

“The Court does not second-guess FDA’s decision-making lightly,” U.S. District Judge Matthew Kacsmaryk wrote in the 67-page opinion released Friday night. “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.”

The immediate impact of Friday’s ruling, which overturned the FDA’s approval of mifepristone in 2000, is unclear. The injunction stopped short of completely withdrawing or suspending the federal agency’s approval of the abortion drug over the objections of pro-life groups.

Kacsmaryk, a Trump-appointed justice, stayed his opinion for seven days to allow the Biden administration time to appeal; shortly after the opinion came out, a Washington State federal judge issued a contradictory ruling. The conflict could eventually escalate the battle to the Supreme Court.

Attorney General Merrick Garland released an official statement “strongly disagreeing” with the ruling and insisting that the Justice Department “will be appealing the court’s decision and seeking a stay pending appeal.”

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

The case stems from a lawsuit filed in November by Alliance Defending Freedom on behalf of the Alliance for Hippocratic Medicine, an organization of pro-life medical groups, as well as four pro-life doctors. The lawsuit claims that the FDA never had the authority to approve the two-pill chemical-abortion regimen when it did so nearly a quarter century ago. Developed in France in the 1980s, the chemical-abortion process involves two pills: mifepristone, a progesterone blocker that kills the unborn baby by depriving it of nutrients, and misoprostol, which causes uterine contractions to empty the uterus.

The lawsuit also claims the FDA failed to properly study the safety of the regimen, and for almost two decades it stonewalled the doctors who were attempting to challenge the approval of the regimen, according to the lawsuit. Rather than increase scrutiny of the pills, the FDA has eliminated safeguards that did exist and has made the drug easier to obtain, according to the Alliance Defending Freedom (ADF), a pro-life organization.

More than half of all abortions in the U.S. are now done using chemical-abortion pills. ADF’s lawsuit is focused on the FDA’s approval of mifepristone.

Kacsmaryk held an initial hearing on March 15, where the plaintiffs asked for a preliminary injunction requiring the FDA to temporarily withdraw or suspend its approval of mifepristone while the legal case continues. Kacsmaryk tried to keep the hearing quiet to avoid disruptions, but news of the hearing leaked. Kacsmaryk indicated that the court staff has faced security issues, including death threats, in connection with the case.

Only 19 reporters and 19 members of the public were allowed in the Amarillo, Texas, courtroom. Journalists who were there reported that Kacsmaryk appeared sympathetic to the abortion-pill challengers. “Kacsmaryk seemed to offer the plaintiffs more windows than the defense to clarify and elaborate on their arguments, especially those related to the FDA’s approval process and the scope of a potential injunction,” NBC News reported.

The Washington Post reported that during the four-hour hearing, the “judge reserved his toughest questions for the government’s lawyers. He expressed skepticism about what he characterized as an accelerated government process for approving mifepristone, and questioned the safety of a more recent FDA decision allowing the medication to be dispensed by mail instead of being given in-person by a doctor.”

But reporters also noted that Kacsmaryk pressed ADF lawyer Erik Baptist about whether he could think of another time a court has ordered the FDA to revoke its long-time approval for a drug. “No, I can’t,” Baptist responded, but he added that some of ADF’s plaintiffs have been trying to fight mifepristone’s approval for two decades through the FDA’s internal processes.

While the hearing was taking place, a small number of protesters dressed as judges, clowns, and kangaroos protested outside, with some holding signs that read “Not Your Uterus, Not Your Decision,” and “Defend Medication Abortion.” The supporters of legal abortion have accused Kacsmaryk of being a clown and running a kangaroo court. Abortion-rights supporters say he has long expressed strong anti-abortion convictions, and they have attacked him as a “villain” and a “lifelong right-wing activist.”

They have also accused of ADF of intentionally filing the lawsuit in Amarillo, Texas, knowing they would almost certainly draw Kacsmaryk, the only judge in the federal district.

The Washington Post has described Kacsmaryk as a “religious conservative who is widely regarded as a thorough and analytical legal thinker, but who also comes to his work with a long history of activism rooted in his religious beliefs.” Before he became a federal judge, Kacsmaryk was a federal prosecutor and then a lawyer for the conservative First Liberty Institute.

The FDA approved the use of the regimen under a section of federal code known as Subpart H, which allows for expedited approval of potentially dangerous drugs that can be used to treat “serious or life-threatening illnesses” or that provide a “meaningful therapeutic advantage over existing treatment.” Subpart H also allows the FDA to place restrictions on the distribution of a drug — including things such as in-person dispensing requirements — to ensure its safe use.

ADF argues that the FDA had no business approving the two-drug abortion-pill regime under Subpart H because pregnancy is not an illness but is rather a “normal physiological state that many females experience one or more times during their childbearing years,” the lawsuit states. ADF lawyers contend that the pills are more dangerous than surgical abortion and that they don’t provide a meaningful therapeutic benefit over surgery.

In recent years, the federal government has made it easier for people to obtain abortion pills. In 2016, the FDA increased the gestational age of the unborn baby when abortion drugs are allowed from seven weeks to ten, reduced the number of required office visits from three to one, allowed nondoctors to prescribe and administer the pills, and eliminated the requirement for prescribers to report nonfatal adverse events from chemical-abortion pills. And in 2021, during the coronavirus pandemic and after Joe Biden was elected president, the FDA announced that it would allow abortion pills to be dispensed through the mail.

Proponents of legalized abortion pills disagree that they are dangerous. Lawyers for the government contend that mifepristone has been used in the U.S. for over two decades now, and serious adverse events associated with its use through 70 days of gestational age are rare.

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Source: Judge Suspends FDA Approval of Abortion Pill Mifepristone | National Review