‘Huge Victory’: 5th Circuit Rules Against Mailing Abortion Pills and Ignoring Women’s Injuries

The Biden administration suffered a major setback, as a federal appeals court has ruled the abortion industry cannot send the abortion pill through the mail, nor ignore the life-threatening harms suffered by the women who take it. The unanimous decision, which pro-life advocates say could save tens of thousands of lives, likely places the pro-life movement and the abortion lobby on another collision course for the Supreme Court.

A three-judge panel of the U.S. Fifth Circuit Court of Appeals, based in New Orleans, ruled against laxer safety standards placed on the abortion pill by the Obama and Biden administrations. In the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, a collection of doctors and OB-GYNs represented by the Alliance Defending Freedom argued the FDA had negligently abused its expedited approval of the chemical abortion drug mifepristone in 2000 for political purposes.

The panel believed the doctors waited too long to file a legal challenge, as the statute of limitations had likely expired. But it overturned abortion expansions made in 2021 by the Biden administration and in 2016 by the Obama-Biden administration. Wednesday’s ruling:

• reduces the number of weeks mifepristone may be dispensed from 10 weeks to seven;
• stipulates that only a physician may prescribe the pill, also known as RU-486;
• ends telemed abortions by requiring an abortion-minded woman to have three in-person visits with a doctor: the first to confirm pregnancy and to take mifepristone, the second to take misoprostol, and a follow-up to check for adverse effects caused by the chemical abortion;
• bars abortion pills from being sent through the mail; and
• mandates that abortionists report all adverse events caused by mifepristone, not merely when the pill causes a woman’s death.

Family Research Council President Tony Perkins called the ruling a “significant victory for the health and safety of women.” Former Congressman Jody Hice said the judgment constitutes “a huge, huge victory for the pro-life movement as a whole and for protecting the health of women.”

The Biden administration “unlawfully allowed for mail-order abortions,” ADF senior counsel Erin Hawley told Hice on “Washington Watch” Thursday. “The Fifth Circuit’s decision puts an end to that.” The decision “makes good on the promise of Dobbs” by stopping abortion activists in Democrat-controlled states from shipping mifepristone into pro-life states, eviscerating state pro-life protections for the unborn.

The ruling reversed abortion-expanding executive actions taken by two Democratic administrations. Barack Obama and Joe Biden both moved to change the rules governing the distribution of mifepristone, known as Risk Evaluation and Mitigation System (REMS). In 2016, the Obama-Biden administration said abortionists no longer had to report serious side effects of the abortion pill to the FDA’s Adverse Events Reporting System (FAERS), only deaths. In December 2021, Biden’s FDA allowed the abortion pills to be prescribed online, without a medical check-up to verify the woman does not have an ectopic pregnancy, or that she is pregnant at all. The impact weighed heavily on the panel.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” wrote Judge Jennifer Elrod in the majority opinion. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”

One of the plaintiffs in the case, the American Association of Pro-Life Obstetricians and Gynecologist (AAPLOG), told The Washington Stand the ruling is “a first step towards reprioritizing women’s health over the interests of the abortion industry and its allies within our profession.” FRC senior fellow Meg Kilgannon stressed that, although the abortion pill is “never safe for the baby” — “the baby is going to die” in any abortion — these terms constitute a “huge improvement over” existing practices. Giving abortion pills directly to the mother is “medically much safer for women” than shipping them via the mail, because it “ensures that no third party can have access to them and then further exploit women: a trafficker, a human trafficker, someone who would give these drugs to a woman unbeknownst to her.”

Pro-life advocates “should be cautiously optimistic” as the case moves forward, Rev. Jim Harden of CompassCare told TWS. “Pending the Supreme Court’s review, the drug remains available to women without medical oversight. Furthermore, the abortion industry continues to illegally ship the drug to women’s homes in violation of 18 U.S. Code § 1461 and 1462,” conventionally known as the Comstock Act. Two days after Christmas 2022, Biden’s Office of Legal Counsel (OLC) issued an opinion that pharmacies may mail or ship abortion pills to pro-life states.

These measures will not take effect immediately, if at all. The Supreme Court issued a stay requiring the case to be fully adjudicated, possibly all the way to the High Court, before the appeals court ruling can take effect. Justices have not yet indicated if they plan to hear the case without a conflicting ruling from another court.

The panoply of possible harms has multiplied as U.S. chemical abortions in the U.S. doubled between 2011 and 2020. Mifepristone now accounts for 54% of all U.S. abortions, according to the pro-abortion Guttmacher Institute. The current regimen of unsupervised “mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year,” said Katie Daniel, Susan B. Anthony Pro-Life America’s state policy director.

Studies have documented that the two-drug abortion cocktail causes four times the level of harmful side effects for women than surgical abortions. The FDA documented 4,207 adverse events from mifepristone use — including 26 deaths, 1,045 hospitalizations, 603 events requiring a blood transfusion, and 413 infections between 2000 and 2021. One study found that as many as 35 of every 100 women who ingest both pills will end up in the emergency room. In a pending lawsuit in New York City, a 16-year-old girl swore that mifepristone left her permanently “sick, sore, lame and disabled” — and caused her child, who survived, to be born with “profound birth defects.”

“I’ve personally treated many women for complications from the abortion pill (mifepristone and misoprostol), including performing emergency surgery on a woman who bled for two months after receiving these drugs,” noted Dr. Ingrid Skop, an OB-GYN who serves as vice president of the Charlotte Lozier Institute. “Those promoting unsupervised DIY abortion pills clearly prioritize the deaths of unborn children over the health and safety of women.”

A majority (55%) of women who consider themselves “pro-choice” regret their decision to take mifepristone, according to a national survey from Support After Abortion. One-third of women subjected to a chemical abortion “reported an adverse change” in their lives, such as “depression, anxiety, substance abuse, and thoughts of suicide,” the group found.

Mail-order abortion “lacks any sort of meaningful medical oversight and places women in danger of serious, life-threatening complications, and ends the lives of unborn children,” Jeanne Mancini, president of the March for Life, told TWS. “The FDA has a solemn duty to prioritize health and safety over politics and should be held accountable for failing to do so.”

The Fifth Circuit partially affirmed and partially vacated a stronger decision from U.S. District Court Judge Matthew Kacsmaryk, a Trump appointee, who ruled on April 7 that FDA wrongly approved mifepristone in 2000. They allowed the drug to be dispensed according to 2016 standards and allowed a 2019 motion for the name-brand Mifeprex to be dispensed as a generic drug.

Pro-life advocates hope if and when the case comes before the Supreme Court, justices will reconsider mifepristone’s controversial approval in 2000, which they contend took place under political pressure from the Clinton administration. In doing so, they state, the FDA violated the Administration Procedure Act.

“The FDA, just like any other agency, has to follow the rules. They didn’t do that for chemical abortion. They bowed to political pressure,” Hawley told Hice. The courts should view the litigation “not as an abortion case, but as a case in which an agency simply failed to follow the rules.” One of the panel’s judges — Judge James Ho, a Trump appointee — dissented that the FDA’s approval of mifepristone should be reversed, pulling mifepristone off all pharmaceutical shelves.

“The FDA exists to protect Americans from dangerous drugs, yet numerous pro-abortion presidents used the agency as a political tool to promote elective abortion at the expense of pregnant women and their preborn children,” Texas Right to Life president John Seago told The Washington Stand. “We hope the court will take accusations against the FDA seriously and will fairly examine the agency’s negligent and politically-motivated approval of this deadly abortion drug over the last 23 years.”

Multiple levels of the Biden administration immediately registered their outrage at Wednesday’s ruling. A spokesperson for Biden’s Justice Department said the administration “strongly disagrees with the Fifth Circuit’s decision” and “will be seeking Supreme Court review.” Vice President Kamala Harris deemed the decision “a threat to a woman’s freedom.” Health and Human Services (HHS) Secretary Xavier Becerra stated that banning the abortion pill would have “a devastating impact on women’s health” by denying them “the medications they need.”

The Biden administration has lost no chance to push back against the Dobbs decision, which overturned Roe v. Wade and returned abortion to the democratic process for the first time in 49 years. Last July, the Biden administration’s Department of Health and Human Services (HHS) sent a guidance to 60,000 pharmacies threatening to take legal “corrective action” against anyone who refuses to dispense the abortion-inducing drug mifepristone to “pregnant people” and explain “how to take” it. Others continually urge the administration to go further. Before the ruling even came down, Senator Ron Wyden (D-Ore.) advised the Biden administration to “ignore the ruling” and “keep this life-saving drug on the market,” likening lawlessness to Abraham Lincoln’s actions freeing the slaves.

Deep-blue states including California, Illinois, Maryland, Massachusetts, New York, Oregon, and Washington state have begun stockpiling mifepristone (and in some cases, misoprostol). So-called “abortion sanctuaries” have promised not to prosecute abortionists who mail mifepristone across state lines, in violation of state or federal law. “Because of this, women are more at risk for chemical abortion injury now than ever before,” said CompassCare’s Jim Harden.

If justices agree to take up the decision, yet another Supreme Court ruling on abortion could impact the 2024 elections. Perkins noted that the three-judge panel — Judges James Ho, Cory Wilson, and Jennifer Walker Elrod — were all appointed by pro-life presidents, highlighting how Christians’ votes lead to concrete decisions that save lives. “With two of the justices on the Fifth Circuit appointed by President Trump” — and Elrod named to the court by George W. Bush — “this ruling also underscores the importance of presidential elections,” Perkins said.

Constitutional lawyers vow they will not relent until the abortion pill, which kills children and hurts women, is removed from all venues. “We won’t rest until the FDA and the profit-driven abortion industry are held accountable for the suffering they’ve inflicted on women and girls, as well as the deaths of countless unborn children,” said Daniels.