Breaking: Appeals court preserves abortion pill approval, reinstates FDA safety standards

Breaking: Appeals court preserves abortion pill approval, reinstates FDA safety standards (Lisa Fotios/Pexels)

Editor's note: On Friday, Apr. 14 U.S. Supreme Court Justice Samuel Alito issued a five-day stay on Judge Kacsmaryk's injunction that would have blocked distribution of mifepristone

Pregnancy help advocates call for focus on women’s safety as case is poised for SCOTUS

A federal appeals court has ruled that the FDA’s 2000 approval of abortion pill mifepristone can remain in effect, but the U.S. Court of Appeals for the 5th Circuit suspended mail-order abortion pills and put on hold changes the FDA made in 2016 and 2021 that loosened safety standards for the abortion drug.

The ruling late Wednesday from the three-judge panel in the 5th Circuit means mifepristone will stay on the market while the landmark abortion pill case proceeds but with reinstatement of key safety protocols from the drug’s initial approval.

A coalition of doctors and medical groups sued the FDA in November 2022 in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration to challenge the approval of mifepristone. 

They argue the FDA had failed in its mission to protect the public’s health because its screening of the abortion drug was reckless and inadequate. 

Critics say as well the FDA exceeded its regulatory authority when it sanctioned mifepristone through its Accelerated Approval Program and that the process was rife with politics favoring abortion proponents. Further, they say that for decades the FDA stonewalled attempts to petition the agency over safety concerns.

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Mifepristone is the first in the two-drug chemical abortion regimen. It blocks progesterone in a pregnant woman’s body, depriving her unborn child of necessary nutrients. The second drug, misoprostol, taken a day or so later, causes the woman to go into labor and deliver her deceased child. 

The safety concerns with mifepristone are numerous, even when dispensed according to the FDA’s previously established safety protocols. Adding to the fundamental safety concerns are both the likelihood that less regulation will foster abuse by human traffickers and other abusers, and the rise of illegal abortion pill websites. Pending the outcome of the case surrounding mifepristone’s approval, there has been mention of abortion providers resorting to misoprostol-only abortion. Misoprostol is not approved for abortion purposes and using it alone would augment concerns for women’s safety. 

Chemical abortion accounts for more than half the abortions conducted in the U.S. and is expected to continue an exponential rise as abortion supporters on all sides look for ways to maintain access, illicit and not, as individual states get back to overseeing their own abortion law following the overturning of Roe v. Wade with the Dobbs ruling.

The FDA’s loosening of its own safety standards for chemical abortion pills in recent years was concurrent with the abortion drugs’ precipitous rise in prevalence. 

Tweet This: “Women and preborn children deserve real healthcare, not the false promises of abortion.”

In 2016 the FDA extended the permitted gestational age of pregnancy at which a woman or girl may take chemical abortion drugs from seven weeks to 10 weeks. Additionally in 2016, the FDA stopped collecting data on non-fatal adverse events related to mifepristone and from then on has only collected data on maternal deaths connected to the drug.

In 2021 the FDA began allowing dispensing of the abortion pill without an in-person medical exam, opening the door to the drugs being available via mail-order, telemedicine, and later through retail pharmacies, all putting women at great risk, pro-life advocates say.

An in-person exam by a doctor is necessary to confirm how far along a woman is in her pregnancy and to rule out ectopic pregnancy and other serious conditions.

U.S. District Judge Matthew Kacsmaryk suspended FDA approval of mifepristone Friday, staying his opinion for seven days to allow the Biden administration time to appeal. 

In an extraordinarily timed ruling not long after Kacsmaryk’s ruling, a Washington state federal judge issued a contradictory ruling to remove dispensing restrictions for mifepristone, blatantly barring the FDA from removing its approval of the drug.

On Monday, April 10, the Biden administration and Danco Laboratories, the pharmaceutical company that makes chemical abortion drugs, filed emergency motions asking the 5th Circuit to issue a stay for Kacsmaryk’s ruling.

Following the 5th Circuit decision Wednesday, the Biden Justice Department announced Thursday it was appealing the ruling to the Supreme Court, seeking a stay on the entire injunction issued by Kacsmaryk.

FDA has continued to fail the American consumer over the last 23 years by removing most of the safety precautions put in place

Pregnancy help advocates have said all along of the case that women’s safety should come before abortion industry profits.

The Senior Director of Medical Impact for the largest network of pregnancy help in the U.S. and globally said that women’s safety was not at the forefront in mifepristone’s approval.

“From the initial approval process of mifepristone, the FDA was heavily influenced by politics and not by adequate studies or record of safety,” said Christa Brown. “The FDA has continued to fail the American consumer for the last 23 years by removing most of the safety precautions put in place. They have ignored the horrible safety track record of mifepristone with one in five women having significant complications after taking the abortion pill.” 

“Despite increased risk in later gestations, abortion providers have ignored the FDA's limits and advanced chemical abortion into the second and sometimes even third trimester,” Brown said.

Heartbeat President Jor-El Godsey echoed that abortion industry’s interest came before the welfare of women in the approval of mifepristone.

"Let's face it, the special interest powerhouse profiteer that is Big Abortion has become part and parcel of Big Pharma,” Godsey said. 

“The courts, hopefully the SCOTUS, will make it plain that government agencies, like the FDA, cannot ignore their own rules just to favor political ideology,” Godsey said.

Abortion providers do not typically follow laws or restrictions that limit abortion

The abortion lobby does not always abide by the rule of law, Brown said, nor can it be counted on to tell the truth about abortion. Abortion drug manufacturers and online purveyors are committed to supplying the drug to the American public despite any FDA approval or legality, she said, and it remains to be seen if abortion providers in the U.S. will abide by the limitations put forth by the courts. 

In addition, Brown said, the media and other apologists are playing on the side of the abortion industry.

“Much of the talk of restrictions and shortages is disseminated in the media in order to prompt a fight for abortion rights,” she said. 

“As we watch history unfold in our states and courtrooms regarding abortion access, it's important to note that's just one reality,” Brown stated. “What we are seeing perpetuated by the media and what we hear from women every day is not the same.” 

“The reality for women in America today is that abortion is readily available throughout all stages of pregnancy,” she said. “Abortion providers do not typically follow laws or restrictions that limit abortion. They often find ways around them in order to provide abortion at any state of pregnancy, in any location.”

Alliance Defending Freedom (ADF) represents the pro-life physicians and medical groups suing to protect women and girls from unnecessary dangers of chemical abortion.

ADF outlined specifics in a press statement Thursday morning:

In its decision, the 5th Circuit ruled that abortionists are no longer allowed to send chemical abortion drugs through the mail, which the FDA had been allowing since 2021, in direct violation of longstanding federal law. Additionally, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from seven weeks’ gestation to 10 weeks’ gestation. The 5th Circuit’s order moved that back to seven weeks’ gestation, protecting the mother from adverse complications that increase with gestational age, reinstated necessary doctor visits, and brought back the requirement that abortionists must check women for complications after their chemical abortions. The 5th Circuit also agreed with Alliance Defending Freedom attorneys that the FDA’s approval of generic mifepristone was unlawful, and that the manufacturer must cease production by Friday.

“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,” ADF Sr. Counsel and Vice President of Center for Life & Regulatory Practice Erin Hawley said in the statement. “The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades.”

Brown noted a report from the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) highlighting the need for an in-person exam prior to a chemical abortion to confirm gestational age, because the risk of needing emergency surgery at 10 weeks of pregnancy is 8%, and just three weeks later at 13 weeks, it's 30%. 

“This is alarming, and many women do not know because they trust the FDA and healthcare providers to tell them the truth,” Brown said. “They are continually lied to through false advertising promising ease, privacy and safety.”

The plaintiffs in the case also say the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions. They argue as well that the FDA ignored the potential impact of the hormone-blocking chemical abortion regimen on the developing bodies of adolescent girls, and eliminated necessary safeguards for pregnant girls and women who undergo chemical abortion.

Women in this country deserve better

Further indicating a disregard for women in the mifepristone approval process is the fact that the FDA’s initial approval of the drug was predicated on the characterization of pregnancy as an “illness” and with the claim that the drug provides a “meaningful therapeutic benefit.” 

“Women in this country deserve better,” said Godsey. 

“They deserve a government committed to protecting public health and not Big Abortion profits,” he said. “Sadly, the same administration attacks local, grassroots efforts and now targets the good work of pregnancy help centers who offer alternatives to abortion." 

What women need is the support of pregnancy help, said Brown.

“During a pregnancy, there are clearly two patients with rights,” she said. “Women and preborn children deserve real healthcare, not the false promises abortion.” 

“The struggles women are facing remain the same and that's what we should be looking at,” said Brown. “They are seeking information, support and hope. No type of abortion offers that.” 

Tweet This: "Women are seeking information, support and hope. No type of abortion offers that.”

Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News.

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