Appeals Court Upholds Some Restrictions on Abortion Pill Mifepristone
A U.S. appeals court has intervened to partially overturn a Texas court’s order that halted the use of the abortion drug mifepristone while a legal battle unfolds.
The pill will remain available nationwide while the case plays out but with more stringent restrictions, including requirements for multiple in-person doctors visits to obtain the drug.
In a ruling late on April 12, the U.S. Fifth Circuit Court of Appeals in New Orleans upheld some of the restrictions from the district court’s April 7 order.
That order was handed down by Trump-appointed U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas. It was due to take effect on April 13, after a seven-day stay to allow the Biden administration time to appeal.
On April 10, the Biden administration and Danco Laboratories, the pill’s manufacturer, filed an emergency motion to stay the ruling.
However, the appeals court declined to block portions of Kacsmaryk’s order.
This means that mifepristone will remain available under the U.S. Food and Drug Administration’s (FDA’s) requirements from 2000 before they were significantly loosened in 2016 and in subsequent years.
In addition to a requirement of three in-person doctor visits, those restrictions include limiting the drug’s use to the first seven weeks of pregnancy, or 50 days, down from the current 10 weeks, or 70 days.
Furthermore, it means that all adverse events related to taking the abortion pill must be reported, which is a significant change from 2016, when nonfatal adverse events were no longer required to be reported.
The appeals court order also means that a 2021 change that allowed mifepristone to be dispensed through the mail during the COVID-19 pandemic will also remain blocked.
Pro-Life Groups Argue FDA Disregarded Safety
The lawsuit before Kacsmaryk was filed against the FDA in November by four pro-life groups led by the recently formed Alliance for Hippocratic Medicine and four pro-life doctors.
They argue that the FDA’s approval was illegal and disregarded the health and safety of women. Their lawsuit cites testimony from doctors who’ve treated dozens of women suffering life-threatening adverse effects from mifepristone.
Both judges’ rulings last week were stays meant to remain in effect while the lawsuits are pending and are not final. However, Kacsmaryk said he thought the pro-life groups were likely to succeed.
Mifepristone is part of a two-drug regimen, administered in combination with misprostol, for medication abortions in the first 10 weeks of pregnancy. The drugs account for more than half of all abortions in the country.
Some abortion providers have said that if mifepristone is unavailable, they would switch to a misoprostol-only regimen for a medication abortion, which is not as effective. It is not yet clear how widely available it would be.
The Supreme Court last year returned the power to make laws governing abortion to the states when it overturned its landmark 1973 Roe v. Wade ruling. Since then, red and blue states have moved to either ban or ensure abortions.
Harm to Women and Doctors
Pro-life group Alliance Defending Freedom (ADF), the plaintiff in the case, argues that the FDA has disregarded women’s safety by illegally approving mifepristone and should be held accountable.
“The FDA put politics ahead of the health of women and girls when it failed to study how dangerous this drug regimen is and when it removed every meaningful safeguard that it previously implemented,” Erik Baptist, senior counsel for ADF, said in a statement released before the appeals court ruling.
The appeals court noted that doctors have had to “devote significant time and resources” to caring for women experiencing mifepristone’s harmful effects and are put under “enormous stress and pressure” to treat these women.
“This harm is sufficiently concrete,” the appeals court ruling states (pdf).
The ruling noted testimony from doctors about facing injury from the irreconcilable choice between performing their jobs and abiding by their consciences. In testimony, one doctor said the strain of treating women suffering an adverse effect from mifepristone “is some of the most emotionally taxing work I have done in my career,” according to the ruling.
“Thus, this is an independent injury because FDA’s actions ‘significantly affect[]’ the doctors’ ‘quality of life,’” the ruling states.
Baptist said the FDA should be accountable for “the damage it has done to the rule of law and the harm it has caused to countless women and girls.”
The Epoch Times contacted the FDA for comment.
