In a victory for women’s health, the U.S. Court of Appeals for the Fifth Circuit ruled August 16, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that the FDA must restore critical safeguards for chemical abortion drugs and end illegal mail-order abortions. Although the case remains stayed until the Supreme Court decides to grant or deny any request to hear it, this is a crucial step in protecting women from the dangers of chemical abortion.
In addition to ending the life of an unborn child, chemical abortions can cause serious health risks to women. As the court noted, FDA’s own data shows that “thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, and required surgery or emergency care to treat those effects.”
In particular, the most updated medication guide suggests that between 2.9% and 4.6% of women visit the emergency room after taking chemical abortion drugs.
FEDERAL APPEALS COURT RESTRICTS ACCESS TO ABORTION PILL MIFEPRISTONE, DRUG REMAINS AVAILABLE
Yet after approving chemical abortion drugs in 2000 — under a regulation that required the FDA to find that pregnancy is a serious or life-threatening illness no less — the FDA stripped away every meaningful safeguard.
In 2016, for example, the FDA extended the permissible age from seven to 10 weeks’ gestation, removed two of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System.
Then, in 2021, the FDA stripped away the last remaining office visit, allowing for chemical abortion drugs to be shipped by mail without a woman every being examined by a health professional.
This means there is no opportunity for a doctor to diagnose an ectopic pregnancy — which occurs in one of every 50 pregnancies and is contraindicated for chemical abortion, potentially resulting in hemorrhaging and even death.
A scared teenager facing an unexpected pregnancy can go online, fill out a form, have mifepristone shipped to her door and ingest the drug all alone, outside the care of a doctor.
In its decision, the Fifth Circuit reminded the FDA that its decisions must comply with the Administrative Procedure Act (APA). This congressional enactment requires agencies to, at a minimum, consider important aspects of the problem it is addressing and offer an explanation consistent with the evidence before the agency.
In the Fifth Circuit’s view, the FDA did neither when it stripped away crucial safeguards from chemical abortion.
The court first held that the FDA’s 2016 actions violated the APA. “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,” the court wrote in its opinion.
In particular, the FDA “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.”
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With respect to the 2021 decision to allow mail-order abortion, the court criticized the FDA for giving dispositive weight to the adverse-event data in FAERS after eliminating the provider-reporting requirement. It is “unreasonable,” the court wrote, “for an agency to eliminate the reporting requirement for [chemical abortion] and then use the resulting absence of data to support its decision.”
The court’s decision reinstated these crucial safeguards and returned chemical abortion to the original 2000 safeguards, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation. And these dangerous drugs may no longer be shipped by mail.
This decision vindicates the handful of brave doctors experienced in caring for pregnant and post-abortive women who are plaintiffs in the case and have been speaking up on behalf of girls and women for years.
For decades, these doctors have called attention to the serious risks and complications of chemical abortion, petitioning the FDA to pull chemical abortion drugs from the market, or at the very least, restore necessary safeguards.
Well now, a new era has come. Thanks to the Fifth Circuit’s ruling, the FDA will finally be held accountable for its reckless disregard for the law and women’s health and safety.
