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Federal Judge Says FDA Wrongfully Approved Abortion Pill

23 years after the FDA approved mifepristone, Judge Matthew Kacsmaryk ruled that the agency chose politics over safety.


A federal judge in Texas ruled Friday that the U.S. Food and Drug Administration did not use proper means to approve the pill responsible for more than half of the nation’s abortions. As a result, mifepristone will be suspended from the FDA’s list of approved drugs to initiate chemical abortions.

“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 judge wrote. “The fact that injunctive relief could upset this ‘status quo’ is therefore an insufficient basis to deny injunctive relief.”

For more than two decades, pro-life doctors have repeatedly asked the FDA via citizen petition to repeal its approval of chemical abortion drugs because “the agency violated federal laws by approving these drugs and ignoring the substantial evidence that these drugs harm women and girls.” Despite the FDA’s legal requirement to address these concerns, the agency repeatedly stonewalled petitioners’ requests for years.

Now, 23 years after the FDA rubber-stamped mifepristone, Trump-appointed U.S. District Judge Matthew Kacsmaryk decided this week from the Amarillo, Texas federal courthouse that the FDA chose politics over safety in endorsing the widespread use of abortion pills.

“To begin, FDA ‘entirely failed to consider an important aspect of the problem’ by omitting any evaluation of the psychological effects of the drug or an evaluation of the long term medical consequences of the drug,” Kacsmaryk wrote.

The Biden administration has seven days to appeal the decision to the State Court of Appeals for Fifth Circuit before the ruling is enforced. Meanwhile, a Washington judge issued a contradicting injunction on Friday evening claiming to prohibit the FDA from changing the abortion pills’ approval status.

In November, Alliance for Hippocratic Medicine, a coalition of five pro-life medical associations and institutions, along with doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado formally alleged in a federal lawsuit that in 2000 the FDA wrongfully used accelerated drug approval authority to endorse abortion pills that can cause dangerous complications. Accelerated drug approval authority is a process largely used to fast track treatments of serious or life-threatening illnesses. The coalition’s pleas for injunction were supported by more than a dozen friends of the court briefs from several pro-life organizations, 67 members of Congress, and 22 states.

Approval of abortion pill mifepristone was only possible, the plaintiffs argued, because the FDA characterized pregnancy as an “illness” and the drugs that cause infant and sometimes mother fatalities as “meaningful therapeutic benefit.” There was no scientific evidence to back that classification.

The FDA is legally tasked with studying the effects of drugs before greenlighting them. When it came to the complications chemical abortion inducers can have on babies, adolescent girls, and women, plaintiffs say the regulatory agency turned a blind eye.

New polling found 75 percent of Americans think the FDA should have performed studies focused on girls under the age of 18 before approving chemical abortion for minors. Instead, the agency doubled down on its dishonesty, something 56 percent of Americans find untrustworthy, according to a March poll conducted by CRC Research for Susan B. Anthony Pro-Life America.

In 2016, the FDA expanded when girls and women could take the pill, changed its dosing, reduced the required number of doctor visits to obtain the drug, allowed more people than licensed doctors to prescribe the pill, and eradicated reporting standards for non-fatal complications from the pills.

Mere months after pro-lifers filed their lawsuit, the FDA quietly modified its already debated regulation to accommodate the White House’s post-Roe activism and open the door for the nation’s pharmacies to become abortion pill dispensaries. Prior to that decision, mifepristone could only be obtained via clinic, doctor, or mail order, a lockdown-era provision the Biden administration made permanent in 2021.

“The FDA never studied the safety of the drug regimen and disregarded clear evidence that the pills cause life-threatening complications. As a result of ignoring the science, women and girls became victims of the FDA’s reckless agenda-driven approval,” said Alliance Defending Freedom senior counsel Erik Baptist, who is representing the pro-life groups, during a Thursday press conference.

Abortion Pills Were Never Safe

Contrary to what courthouse protestors, the FDA, and CNN claim about the “safety” of abortion pills, mifepristone is responsible for a 500 percent increase in abortion-related emergency room visits. One longitudinal study revealed that in at least 17 states with taxpayer-funded abortion, many of which have relaxed chemical abortion laws, emergency room visits within 30 days following chemical abortions grew to nearly 34 percent of all ER visits as of 2015.

The same study concluded “chemical abortion is consistently and progressively associated with more postabortion ER visit morbidity than surgical abortion” and the risks have increase  year after year. Most studies don’t cover the emotional toll chemical abortions often have on women either.

Already, corporate media outlets like Slate and politicians like Sen. Ron Wyden, D-Ore., are calling on the Biden administration, the FDA, and members of the public to ignore the Trump appointee’s ruling.

Dr. Ingrid Skop, a senior fellow and director of medical affairs for Charlotte Lozier Institute, told The Federalist that pro-abortion activists are going one step further by promoting the use of one part of the chemical abortion drug regimen by itself.

Misoprostol, the stomach ulcer drug often prescribed with mifepristone to aid abortion, will remain on the market but is not approved by the FDA for abortions because “no company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.” Not only is the ulcer drug even less regulated by FDA than mifepristone, but Skop said it is linked to far more complications when used for chemical abortion alone.

“Nearly one out of four women who take misoprostol are going to need surgery. So it’s even going to get worse going from one out of 20 [post-mifepristone] to one out of five or one out of four,” Skop said.

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