Five months ago, the U.S. Fifth Circuit Court of Appeals placed restrictions on the distribution of the chemical abortion pill mifepristone after determining that the U.S. Food and Drug Administration (FDA) violated federal law, ignored science, and failed to put the health and safety of women first while placing and keeping the drug on the market.

The FDA is appealing this decision to continue appeasing its abortion industry pals. Liberty Counsel is once again filing a brief to fight the blood-soaked abortion industry before the U.S. Supreme Court. Read on. — Mat

In an August 2023 ruling on Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, the Fifth Circuit Court of Appeals called out the FDA on three key issues. Ever eager to enable the demise of yet more babies, the Biden administration is appealing the decision.

Liberty Counsel will be filing a brief with the U.S. Supreme Court.

First, the Appeals Court found that the FDA treated pregnancy as an “illness” and improperly categorized mifepristone under an approval protocol meant for drugs treating serious illnesses to get it approved more rapidly.

Second, the Court found the FDA knowingly used deficient data (underreported adverse events) to declare mifepristone “safe.” And third, the Court determined the FDA violated federal law by choosing not to enforce the requirement for women to get the drug in-person from a medical provider and making it available by mail. While the Fifth Circuit allowed the drug to remain FDA approved, it reinstated the regulations for in-person visits and mandated the FDA comply with federal law and not allow the drug to be sent by mail.

Sarah Harrington, attorney for the FDA, told the Appeals Court judges that a lower court’s ruling to suspend mifepristone’s approval was an “unprecedented and unjustified attack on the FDA’s scientific expertise.”

“It’s not a court’s role to second guess that expertise,” Harrington said.

Appeals Court Judge James Ho disagreed and stated it is the role of the courts to look at any agency.

In the Court’s opinion, Judge Ho wrote, “Their message is simple: The scientists at the FDA can do no wrong. So courts have no business reviewing their actions. That’s mistaken on multiple levels. … We all make mistakes. And the FDA has made plenty.” Judge Ho pointed out that nearly one-third of all drugs approved by the FDA since mifepristone’s 2000 approval have safety issues, and because of that, the FDA does not deserve “blind deference.”

Federal code allows the FDA to accelerate approval for drugs that prove effective in treating a “serious or life-threatening illness.” By categorizing mifepristone as treating a “serious illness,” the FDA accelerated the drug’s approval under less rigorous safety criteria.

Judge Ho wrote, “The FDA violated that principle when it approved Mifepristone ... pregnancy is plainly not an illness. So it was unlawful for the FDA to approve Mifepristone…The FDA simply got it wrong.”

In addition to a questionable approval process, the Court determined that the FDA’s decision to allow mifepristone to be distributed via mail violated the 1873 Comstock Act. While the law has been reinterpreted and modified over the last 150 years, the mailing of abortifacients is plainly illegal.

According to the Fifth Circuit ruling, the FDA approved mifepristone even though clinical trials showed up to 7.9% of women needed surgical intervention after taking the drug. Yet, the FDA orally argued that the drug’s serious complication rate is “well under 1 percent.”

However, the researchers at the University of California, San Francisco, who conducted the 2015 study, limited the definition of “serious complications” to “hospital admission, surgery, or blood transfusion.” All other adverse events, including infection, hemorrhage, and uterine perforations, were classified as “minor.” Taking both “serious” and “minor” complications together, the study revealed a 5.19% complication rate.

Then in 2016, the FDA no longer required medical providers to report adverse events associated with mifepristone in the FDA Adverse Event Reporting System (FAERS), and only required providers to report deaths.

Regarding this, the Fifth Circuit wrote that “considerable evidence shows that FAERS data is insufficient to draw general conclusions about adverse events. ... ‘FDA itself recognizes that FAERS data cannot be used to calculate the incidence of adverse event or medication error in the U.S. population.’ … consequently, many adverse events will go unreported.”

The evidence showed that “thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug.” 

In 2021, the FDA refused to enforce the in-person dispensing requirement.

The Court said, “FDA admits that none of the studies it relied on examined the effect of implementing all of those changes together. ... FDA neither considered the effects as a whole, nor explained why it declined to do so.”

The FDA is failing the American people and urgently needs reform. Rather than objectively and scientifically approving medicines, the FDA is yielding to the interests of the abortion industry and pharmaceutical companies. This is resulting in chemical abortions that harm women physically and emotionally and cruelly kill defenseless children in the womb. The FDA needs a complete overhaul.

We fight every day to preserve life and liberty. We have many more cases working their way through the courts and pending before the U.S. Supreme Court.

Thank you for loving life and liberty as much as we do!

Mat Staver
Founder and Chairman
Liberty Counsel

TAKE ACTION

Fax Congress now & sign the petition!

Sources:

“Alliance Hippocratic Medicine v. FDA, No. 23-10362 (5th Cir. 2023).” Justia Law. Accessed January 19, 2024. https://law.justia.com/cases/federal/appellate-courts/ca5/23-10362/23-10362-2023-08-16.html.