By Peter Pinedo
Washington, D.C. Newsroom, Aug 16, 2023 / 14:32 pm
The 5th U.S. Circuit Court of Appeals approved additional abortion pill restrictions, including ending mail-order abortions, in a Wednesday ruling in the high-stakes abortion case Alliance for Hippocratic Medicine v. Food and Drug Administration (AHM v. FDA).
The court did not disapprove all use of abortion pills but rather ruled that the FDA must reinstate restrictions in place before 2016, most notably banning administering the pills through the mail or via telemedicine.
In loosening its restrictions on the abortion pill, mifepristone, the 5th Circuit Court said the FDA “failed to address several important concerns about whether the drug would be safe for the women who use it.”
The court said that the FDA failed to “consider the cumulative effect of removing several important safeguards” and “to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
Because of this finding, variations of the most commonly used abortion pill, such as Mifeprex and generic mifepristone, “will remain available under the safety restrictions that were in effect prior to 2016.”
Erin Hawley, senior counsel at the Alliance Defending Freedom, the firm representing AHM and several other pro-life groups in the case, explained that though “there is no immediate effect,” once reviewed and certified by the Supreme Court, the ruling will mandate that the FDA restore its original regulations in place in 2000.
According to Hawley, this means that the mifepristone approval will be capped at seven weeks, rather than 10, and require at least three in-person doctor visits to administer the drug.
“This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women,” Hawley said.
“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” she added. “The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law.”
The Biden administration has not yet issued a response to the ruling but will likely appeal to the Supreme Court.
Mifepristone is the first drug used in what is commonly a two-step regimen for a chemical abortion. The pill works to kill an unborn baby by cutting off the nutrients necessary for it to continue developing.
Chemical abortions currently account for over half of all U.S. abortions.
This is the latest development in what could be the most consequential abortion case since Dobbs v. Jackson Women’s Health Organization, the case that overturned Roe v. Wade.
The case first drew national attention when federal Texas judge Matthew Kacsmaryk issued a controversial ruling on April 7 that suspended the FDA’s approval of the abortion drug mifepristone on the grounds that approval was given “based on plainly unsound reasoning and studies that did not support its conclusions.”
The Biden administration immediately issued an emergency appeal to block the ruling first to a three-judge panel in the 5th Circuit and then to the Supreme Court.
In a 7-2 decision the Supreme Court temporarily blocked Kacsmaryk’s ruling and returned the case to the 5th Circuit for full review.
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According to Katie Daniel, state policy director at Susan B. Anthony Pro-Life America, “mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year.”
“The FDA ignored science and its own rules when it rubber-stamped Democrats’ reckless mail-order abortion scheme,” Daniel continued. “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.”
This is a developing story.
