ALEXANDRIA, VA – Last month, 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.
In Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, the Appeals Court called out the FDA on three key issues. First, the 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 as “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.
In a recently published white paper, the National Right to Life Committee revealed how the news media superficially reported on the Court’s ruling to impose the restrictions. Authored by Dr. Randall K. O’Bannon, the white paper titled, “What the Media Missed in Its Coverage of the U.S. Fifth Circuit Court of Appeals Decision Regarding: Mifepristone,” explains how the media failed to convey the “legal reasoning and medical evidence” behind the Court’s decision.
In summarizing the Fifth Circuit’s ruling, Dr. O’Bannon outlined several key points that reveal not just problems with Mifepristone but expose core problems at the FDA.
“The FDA doesn’t think anyone…has the right to challenge their decisions.”
During the oral argument phase of the case, attorney Sarah Harrington 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,” said Harrington.
Appeals Court Judge James C. Ho disagreed and stated it’s 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.”
“The FDA thinks it can bend the rules to do whatever it wants.”
Federal code allows the FDA to accelerate approval for drugs that prove effective in treating a “serious or life-threatening illness.” The section of code is called Subpart H. 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 under Subpart H…pregnancy is plainly not an illness. So it was unlawful for the FDA to approve Mifepristone under Subpart H…The FDA simply got it wrong.”
In addition to a questionable approval process, the Appeals Court determined the FDA’s decision to allow Mifepristone to be distributed via mail directly 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.
Dr. O’Bannon stated, “The agency bent the rules to consider Mifepristone and get it through the process.”
“Safe, simple chemical abortions are a crumbling myth.”
According to the Fifth Circuit ruling, the FDA approved Mifepristone even though clinical trials showed up to 7.9 percent of women needed surgical intervention after taking the drug. Yet, the FDA orally argued 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 used to make this claim, limited the definition of “serious complications” to “hospital admission, surgery, or blood transfusion.” All other adverse events, including infection, hemorrhage, uterine perforations, and were classified as “minor.” Taking both “serious” and “minor” complications together, the study revealed a 5.19 percent 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, “…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 Court declared that independent studies and doctor testimonies show 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 then chose not to enforce the in-person dispensing requirement. The plaintiffs in the case asserted that the FDA failed to consider the impacts of their decisions on whether women could skip consultations, administer the drug themselves at home, and manage the complications alone.
Addressing this, the Appeals 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.”
In the white paper, Dr. O’Bannon concluded that the FDA used an “unrecognizable” process for Mifepristone and the media either ignored it or didn’t even bother to dig deeper. He noted that if the FDA was trying to treat a disease or “deleterious condition” then some actions could be defensible, but by putting the drug in healthy women and treating the unborn child as a “tumor” makes “little sense.”
“The FDA lacked this fundamental commitment to human life, and thus failed in its statutory duties,” wrote Dr. O’Bannon.
In November 2022, the Alliance for Hippocratic Medicine (AHM) and three of its member medical associations along with four doctors experienced in treating pregnant and post-abortive women filed suit against the FDA and Mifepristone’s manufacturer, Danco Laboratories, for their illegal and improper actions in approving the chemical abortion drug. The AHM is a nonprofit organization representing nearly 30,000 health care professionals. The AHM’s member organizations involved in the suit are the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations. The lawsuit is the first of its kind to challenge federal approval of abortion drugs.
Danco Laboratories has petitioned the U.S. Supreme Court to review the ruling so it can keep Mifepristone widely available. If the High Court takes the case, Liberty Counsel plans to file an amicus brief detailing the catastrophic effects of chemical abortion.
Liberty Counsel Founder and Chairman Mat Staver wrote, “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.”