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BREAKING: Fifth Circuit allows abortion drugs to stay on market but restores FDA’s original safe-use guidelines

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UPDATE: In a 2-1 vote, a panel for the Fifth Circuit U.S. Court of Appeals ruled just before midnight last night to preserve access to the chemical abortion drugs Mifepristone and Misoprostol but also restored the original, tighter safe-use guidelines put in place in 2000, when the drugs were first approved by the FDA.

This partially overrides the ruling by U.S. District Judge Matthew Kacsmaryk, who issued a preliminary injunction that would have blocked the FDA approval of the drugs and taken them off the market pending judicial review.

Under the appellate ruling, the two abortion drugs can only be prescribed if the gestational age of the child is 7 weeks or less, rather than the later guidelines of 10 weeks. In addition, physicians must administer the two-step regimen in the office, meaning the pills can no longer be ordered online and sent to the patient by mail.

Erin Hawley, Senior Counsel for Alliance Defending Freedom, which brought the case Alliance for Hippocratic Medicine vs. FDA on behalf of four national physician groups and four individual doctors, responded to the new ruling in a statement, saying:

“The FDA put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented. The FDA should have to answer for the damage it has done to the rule of law and the harm it has caused to countless women and girls. Federal agencies that act lawlessly must be held accountable. The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades. The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law.”

The decision is likely to be appealed to the Supreme Court.

Without any additional intervention, the Fifth Circuit’s ruling will take effect on Friday.

ORIGINAL STORY

In the span on one hour last Friday, a federal court in Texas halted the use of chemical abortion drugs after finding that the Food and Drug Administration (FDA) repeatedly broke the law in its initial approval of mifepristone and misoprostol, while a second federal judge ordered the FDA to keep both drugs available in the 17 states that sued to keep the approval in place.


Quick Facts


Legal experts say that the polar opposite orders will accelerate the appellate process and increase the likelihood that the Supreme Court will eventually intervene.

The case against the FDA was originally brought by Alliance Defending Freedom on behalf of the Alliance for Hippocratic Medicine, three other national physician groups, and four doctors. The suit argued that the FDA rushed the approval of the abortion drugs mifepristone and misoprostol in the early 2000s by using an emergency approval process reserved for life-threatening illnesses with no other therapeutic options; failing to do the requisite safety studies; and ignoring the growing evidence that the abortion drugs cause death and complications for women, including infection, bleeding, and the need for hysterectomies, in addition to causing the death of the unborn child.

According to the lawsuit, medical abortions have a complication rate that is four times that of surgical abortions (with the rate of severe bleeding even higher), and physicians, not the drug manufacturer or the FDA, are the ones held accountable for that reality through higher medical malpractice premiums and lower quality ratings.

The plaintiffs said they first petitioned the agency challenging the legality of its approval process in 2002. The agency, by law, was required to respond within 180 days but instead took 4,971 days before it finally responded to the plaintiffs’ complaint in 2016, at which pint it rejected their concerns. When confronted with a second petition in 2018, the agency took nearly 1,000 days to respond.

The plaintiffs also charged that the FDA has increased the risk to women by loosening the requirements of what it originally defined as “safe use,” again without the mandated safety studies.

For example, the gestation age at which the drugs can be administered has been increased from 7 weeks to 10 weeks. The dosage has been significantly increased. While doctors were originally required to dispense the drugs during an in-person office visit and to see the patient a third time to assess for complications and overall health, the FDA recently reduced that protocol to just one visit, which can be satisfied through a telehealth consultation, and now allows patients to obtain the drugs through an online pharmacy and the U.S. mail. The FDA also abandoned its typical drug safety requirement to track complications.

In a 67-page ruling, U.S. District Court Judge Matthew Kacsmaryk for the District of Northern Texas agreed with the plaintiffs that the FDA’s process was substandard and illegal and granted an injunction that temporarily blocks the drugs’ approval and use. He 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. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion — which was the ‘whole idea of mifepristone.’”

Kacsmaryk also addressed the FDA’s recent decision to change its safe-use guidelines and protocols, writing,

“Whether FDA abandoned its proposed restrictions because of political pressure or not, one thing is clear: the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions. Due to FDA’s lax reporting requirements, the exact number is not ascertainable. But it is likely far higher than its data indicate for reasons previously mentioned. Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety. FDA’s failure to insist on the inclusion of its proposed safety restrictions was not ‘the product of reasoned decisionmaking.’” 

He also noted that just because abortion drugs have been on the market for 23 years doesn’t mean they can’t be pulled, noting,

“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 fact that injunctive relief could upset this “status quo” is therefore an insufficient basis to deny injunctive relief.”

Despite his strong ruling, Kacsmaryk granted a seven-day administrative stay to his order to give the government the opportunity to appeal his ruling to the Fifth Circuit Court of Appeals, which it did on emergency basis on Friday night.

An hour after Kacsmaryk’s ruling was published, in a case brought by 17 states that had sued to protect the availability of chemical abortion, U.S. District Court Judge Thomas O. Rice of the eastern district of Washington ordered the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in the plaintiff states.

The two dueling decisions have put the future of abortion drugs in limbo. The appellate process will be accelerated and the Supreme Court is highly likely to get involved.

In response, the Biden administration called the Texas ruling “manifestly untimely,” unscientific, and “misguided” in its appellate filing, but also ignored calls from some pro-abortion activists and members of Congress to ignore the ruling, saying such an action would set a “dangerous precedent.”

The job of the executive branch is to faithfully execute laws as passed by the legislature and interpreted by the judiciary. Unfortunately, had the FDA followed the law 23 years ago and adjudicated the plaintiffs’ concerns about the safety of these drugs, we wouldn’t be in this mess today.

The problem is that, increasingly, federal agencies are following their own political agenda. In this case, the FDA’s goal was to increase access to abortion, not to ensure the safety of women and girls. That’s why the FDA defined pregnancy as an “illness” and chemical abortion drugs as a “therapy” and it’s why they used an emergency process reserved only for diseases, like AIDS and certain cancers, that were life-threatening and for which there were no other treatments available.

And it succeeded. The abortion drugs do exactly as the FDA, the drug manufacturers, and the abortion industry intended — they “cure” the “illness” of pregnancy by killing the child in the womb. And because of the FDA’s decision to “stonewall judicial review for more than two decades,” as Judge Kacsmaryk characterized their actions, they been free to ensure the deaths of millions of children. Today, medical abortion accounts for more than half of all abortions.

But their actions have also heaped a lot of misery on women. Chemical abortion is not, as abortion activists and the media lead women to believe, a matter of taking a couple of pills and presto, the baby is gone and you’re free to get on with your life. The drug regimen involves two steps: mifepristone blocks the release of hormone progesterone, effectively starving the baby of the hormones it needs to grow and killing it, while misoprostol causes the uterine cramping needed to expel the baby’s dead body.

And that means it’s painful, stressful, and can be incredibly dangerous. Women using this abortion method are frequently treated and hospitalized for excessive bleeding and infection. Women have died, and women have had to be treated through hysterectomy, ruining their chances to ever be mothers.

And most women have little understanding of the potential side effects or that they are likely to go through this trauma on their own alone and that they might even be forced to see and hold their tiny, dead child.

Proverbs 28:13 tells us that “He who conceals his transgressions will not prosper,” while John 3:20 says, “For everyone who does evil hates the Light, and does not come to the Light for fear that his deeds will be exposed.”

The FDA needs to learn that while you can ignore the law and you can cover up the truth — you can’t do it forever. Judge Kacsmaryk’s court ruling on abortion drugs is a reckoning that is long overdue.

Women are being put at severe and unexpected risk of harm as a result of their rushed and illegal approval of chemical abortion drugs. If the FDA truly cares about women and their health and safety, it should be more than willing to pull the drug and do the requisite research, study, and fixes. After all, that is its actual mission and role — not furthering a political agenda.


Ready to dive deeper into the intersection of faith and policy? Head over to our Theology of Politics series page where we’ve published several long-form pieces that will help Christians navigate where their faith should direct them on political issues.

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