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A federal appeals court is cracking down on the abortion pill, ordering the federal government to restore numerous safeguards it had discarded in 2016.
In a Wednesday ruling, the 5th U.S. Circuit Court of Appeals ordered the Food and Drug Administration (FDA) to cease all mail-order abortions; to lower the gestational age of the baby being terminated from 10 weeks to 7 weeks; to restore the requirement of doctor visits for women; and to require that abortionists examine women for complications after taking the abortion pill.
The debate centers on the FDA's 2000 approval of Mifepristone, also known as RU486, and commonly sold under the name Mifeprex. In 2016, the FDA made significant decisions with regard to lifting restrictions on Mifepristone:
The FDA removed four of the original safety restrictions by (1) increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion (the "2016 Major REMS Changes")
The court notes that the FDA "failed to examine the relevant data" when it made these changes. It also "relied on zero studies that evaluated the safety-and-effectiveness consequences of the 2016 Major REMS Changes as a whole."
The appeals court agreed that the plaintiffs would likely succeed in proving the FDA acted in an arbitrary and capricious manner when it removed those safety restrictions in 2016: "That's because FDA eliminated REMS safeguards based on studies that included those very safeguards."
Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. ... For nearly a decade, the agency collectsthose studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures.
Before 2016, companies were required to report all complications arising from the abortion pill. After 2016, they only had to report deaths — a significantly smaller number.
"After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is 'safe,'" notes the 5th Circuit, which blasted the FDA for this "ostrich's-head-in-the-sand approach," calling it "deeply troubling."
Putting it into perspective, a 2021 study published in the peer-reviewed journal Law & Medicine, titled "Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019," notes 3,197 total adverse effects from the abortion drug. Among them, 20 were deaths, while the vast majority were either life-threatening or severe.
The FDA merely requires that the 20 deaths be reported, while allowing the thousands of other severe complications arising from mifepristone to be hidden from the public.
"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," said Erin Hawley, senior counsel at Alliance Defending Freedom (ADF), which represents the plaintiffs.
"The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades," she noted. "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 lawsuit was originally filed by a group of physicians and medical associations. After a lower court granted the plaintiffs' petition for an injunction of the abortion drug, the Biden administration appealed the ruling.
Among the FDA's arguments, it tried to make the case that neither the doctors nor the medical groups had standing to sue. The 5th Circuit disagreed, noting that both groups suffer concrete injury from complications arising from mifepristone.
The FDA also argued that granting physicians standing to sue over mifepristone would open the floodgates to countless lawsuits by doctors over injuries from drugs as benign as Ibuprofen.
The court refuted this argument by noting that mifepristone contains a special warning, called a "black box" warning — mandated by the FDA itself — which warns women of the potential for serious injury or death. No such "black box" warning is required of Ibuprofen.
Mifepristone, also known as RU486, is the first in a two-drug regimen used to kill unborn children. It works by flooding the body with a chemical that blocks progesterone, naturally produced during pregnancy. The second drug, Misoprostol, brings on severe cramping and bleeding, leading to expelling the child from the mother's body.
Women's testimonies from the United Kingdom, where mifepristone is freely available by mail, reveal the process is far more agonizing and traumatizing than the public is led to believe.
"The nurse told me I might feel a bit of pain, but some women find it harder than others and some have had periods that are worse," said a woman named Emily to the Daily Mail.
"However, within hours of taking the second dose she was hunched over the toilet, throwing up in a bucket and screaming in agony," the article continues. "'I have a high pain tolerance. I've broken bones and suffer chronic migraines, but I've never felt pain like it. I was terrified.'"
Katherine, who also spoke to the U.K. paper, said, "I thought an abortion at home would be less traumatic. But at least in hospital, under anaesthetic, I was pain-free. This was still horrible. I was writhing in agony. I had horrific cramps for five hours."
"If I'd had counseling in a clinic, I think I would have decided to go ahead with the pregnancy," she added.