Leadership from the largest network of pregnancy help in the U.S. and internationally praised the Fifth Circuit Court of Appeals panel’s ruling restoring safety measures associated with the chemical abortion pill regimen.
The three-judge panel ruled unanimously Wednesday in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that the FDA acted unlawfully when it reduced regulations in 2016 and 2021 related to the abortion drug mifepristone, and had given insufficient consideration to recognized safety issues with the drug.
Chemical abortion drug Mifeprex will remain available under the safety restrictions that were in effect prior to 2016 while the case proceeds, according to the ruling, and generic mifepristone will also remain available under those same restrictions. The decision reinstates the original safeguards for dispensing the abortion pill from the year 2000 when it was approved, this included the seven weeks’ gestational limitation, in-person physician visits, non-fatal adverse event reporting, and that the drugs be dispensed by a doctor.
The Fifth Circuit’s ruling also bars abortion providers from sending chemical abortion drugs via the mail.
Pro-life advocates had long said that the approval process of mifepristone was not rigorous and instead political, in favor of the abortion industry, and worse, put the safety of women and girls at risk.
“The FDA should pursue the best interest of the people and not the politics of Big Pharma and the ideology of Big Abortion,” said Jor-El Godsey, president of Heartbeat International.
“Women deserve better than abortion,” Godsey said. “Restoring protections for women should be followed by real research into the full impact chemical abortions have. More should be done at the federal and state level to help women have true choice and not be forced into an abortion decision they don’t really want.”
Heartbeat’s Senior Director of Medical Impact Christa Brown concurred.
“This is a tremendous victory for women and children of America,” Brown said.
“Mifepristone is a dangerous drug that currently has few safety guardrails,” said Brown. “Women are now presenting in emergency departments across America with serious complications including infection (septic uterus) and hemorrhaging after consuming mifepristone.”
“It should be alarming to our healthcare system that 5-8% of the thousands of women who consume mifepristone every day in the U.S. need emergency care for complications,” she said. “It should also be alarming to all Americans that our children are being destroyed in the masses with these drugs.”
Widespread reports hold that more than half of all abortions conducted in the U.S. are done so through chemical abortion pills. Brown noted that Support After Abortion estimates that 80% of all abortions are now chemical.
Chemical abortion consists of two pills. The first, mifepristone, blocks progesterone in the pregnant mom’s system, starving her unborn child of necessary nutrients. The second drug, misoprostol, taken a day or so later, causes the mother to go into labor and deliver her presumably deceased child.
The FDA had approved mifepristone by defining pregnancy as an “illness” and with the claim that the drug provides a “meaningful therapeutic benefit.”
The federal agency had been permitting mail order dispensing of the abortion drugs since 2021, which is a direct violation of a longtime federal law, according to Alliance Defending Freedom (ADF) which is representing the physicians and medical associations in the case.
Further, in 2016 the FDA moved the accepted gestational age in pregnancy at which a woman or girl may take chemical abortion drugs from seven to 10 weeks.
The FDA also withdrew two of three required in-person doctor visits, permitted non-doctors to prescribe the drugs, and removed the requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System.
From the Fifth Circuit’s August 16 ruling:
“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. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
ADF had filed the lawsuit against the FDA in November 2022 representing the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and Doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado. The suit is the first to challenge the federal government over its approval of chemical abortion drugs.
Erin Hawley, senior counsel and vice president of the Center for Life and regulatory practice at Alliance Defending Freedom, commented on the ruling upon its release, remarking on the political nature of the FDA’s approval and regulation of mifepristone.
“Today the Fifth Circuit rightly required the FDA to do its job and to restore crucial safeguards for women and girls, including ending illegal mail order abortions,” Hawley said. “The FDA will finally be made to account for the damage it has caused to the health of countless women and the rule of law by unlawfully removing almost every meaningful safeguard from the chemical abortion drug regimen.”
“The FDA’s unprecedented and unlawful actions did not reflect scientific judgement,” she said, “but rather reveal politically driven decisions to push a dangerous drug regimen without regard for women’s health or the rule of law.”
“This is a significant victory for the doctors and the medical associations we represent,” said Hawley, “and more importantly, the health and safety of women.”
The Alliance for Hippocratic Medicine also argues that the FDA has stonewalled attempts to hold it accountable for its handling of the approval of the abortion pill for the last two decades.
U.S. District Judge Matthew Kacsmaryk, agreed, and had found that the initial approval of mifepristone in 2000, along with the more recent FDA decisions permitting the drug to be dispensed through telemedicine, via mail, and at retail pharmacies, were unlawful. Kacsmaryk suspended the abortion pill’s approval April 7 with a seven-day stay allowing for Biden administration attorneys to appeal.
A Washington State federal judge quickly issued a ruling contradicting Kacsmaryk’s, prohibiting the FDA from removing approval, prompting speculation that case was being readied for the Supreme Court.
A different panel of the Fifth Circuit Court of Appeals restored access to the abortion pill on April 12, while ordering the FDA changes to loosen regulations and increase access be put on hold.
The Biden administration appealed to the Supreme Court April 14, asking for an administrative stay pending its appeal to the Fifth Circuit. The Supreme Court granted a five-day stay April 14, followed by a two-day extension, after which it upheld access to the abortion pill while litigation proceeds, with Justices Clarence Thomas and Samuel Alito dissenting from the Court’s 7-2 decision.
The FDA had also recently weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for mifepristone to allow for it to be dispensed and mailed by pharmacies.
Brown remained critical of this lax approach to regulating a drug that is pushed by abortion advocates as the answer to unplanned pregnancy, with women paying the price.
“The FDA, motivated more by political agendas and protecting abortion pill manufacturer Danco's profit rather than protecting the American consumer, has continued to weaken the longstanding safety protocols, despite limited data collection and evidence of injuries to thousands of women,” she said. “The FDA exists to protect the public health by ensuring the safety of drugs but has failed Americans by approving and expanding chemical abortion.”
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REMS have only been placed on about 70 of the more than 20,000 FDA approved drugs, Brown explained.
“In other words,” she said, “few drugs are as dangerous as mifepristone.”
Between 2000 and 2021, Brown said, the FDA documented a total of 4,207 adverse events — including 26 deaths, 1,045 hospitalizations, 603 events requiring a blood transfusion, and 413 infections.
“This lawsuit sought to rectify those tragic errors,” she said. “And this ruling is a step in the right direction.”