Court lets abortion pill stay on market, but not in mail; FDA’s relaxed rules exceed comfort level

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A federal appeals court ruled Wednesday that the abortion pill can remain on the market, though the judges halted recent moves to expand access, such as the Biden administration’s plan to make it available to women through the mail.

The 5th U.S. Circuit Court of Appeals said too much time has elapsed to revisit the Food and Drug Administration’s 2000 certification of the pill, mifepristone.

The three-judge panel issued an injunction blocking some of the changes made since 2016 that relaxed rules on access to the pill. The court decided that the agency cut too many corners.

Some of the changes made by the Obama administration removed a requirement for a doctor to prescribe the pill, raised the maximum gestational age for use to 10 weeks and canceled the need for an in-person follow-up visit. The Biden administration introduced the mail option.

“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,” Judge Jennifer Walker Elrod, a Bush appointee, said in the court’s chief opinion.

The ruling is on hold under a previous order of the Supreme Court. The Justice Department said it will appeal the new decision to the high court.

The White House said Wednesday it “strongly disagrees” with the 5th Circuit’s ruling.

“If the Fifth Circuit’s ruling stands, it will significantly roll back the ability for women in every state to get the health care they need, and undermine FDA’s scientific, evidence-based process for approving safe and effective medications that patients rely on,” said White House press secretary Karine Jean-Pierre. “The administration will continue to stand by FDA’s independent approval of mifepristone as safe and effective.”

The American Association of Pro-Life Obstetricians and Gynecologists, a plaintiff in the legal battle, said the ruling was “a victory for our patients.”

“Over the past two decades, the FDA has repeatedly removed necessary safeguards” which has “placed women and girls at greater risk of life-threatening complications, as well as coerced abortion by abusers and traffickers,” the group said.

“Today’s ruling by the Fifth Circuit Court of Appeals reinstating these basic safeguards and stopping the dangerous practice of mail-order abortions is a first step towards reprioritizing women’s health over the interests of the abortion industry and its allies within our profession. As physicians, we will continue to fight for all our patients to be able to receive the best fully informed and evidence-based healthcare possible,” the organization said in a press release.

Mifepristone has become a major battleground in abortion politics since its approval by the Clinton administration.

It blocks the hormone progesterone, which is required for a pregnancy to continue. Another drug, misoprostol, is then administered to expel the contents of the uterus.

The drug has marked a revolution in abortion. Medication abortions now account for more than half of all abortions.

Pro-life activists say medication abortions are inherently risky and leave women without the care of an in-person procedure.

Pro-life doctors brought the court challenge. They said the original 2000 certification and subsequent moves to expand access were wrong.

The Biden administration and Danco Laboratories, the original manufacturer, fought the challenge.

U.S. District Judge Matthew Kacsmaryk, a Trump appointee, sided with the pro-life doctors. He said the FDA sidestepped too much science and “acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

The Supreme Court allowed the drug’s certification and the subsequent rule changes to remain in effect while the case winds its way through higher courts.

The Biden administration says prohibiting the pill undermines science and creates chaos in the courts.

Officials pointed to a district court in Washington state that upheld the FDA’s decisions on mifepristone.

In the appeals court ruling Wednesday, all three judges ruled that the Obama and Biden administration moves to expand access were too hasty.

The court said the FDA considered each change separately but failed to consider the cumulative effects and whether that would alter the risks to women. The judges said the agency didn’t gather enough evidence to show that mifepristone could be used safely without an in-person doctor’s visit.

One member of the panel, Judge James Ho, said he would have gone further and upheld Judge Kacsmaryk’s injunction against the 2000 certification.

The Trump appointee detailed a series of bungles by the FDA in urging strict adherence to federal laws governing the approval of medications.

“Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect,” he wrote. “None of us are. We all make mistakes. And the FDA has made plenty.”

The court ruled a year after the Supreme Court overturned the 1973 Roe v. Wade decision that established a national right to abortion. In a 5-4 ruling, the justices returned the abortion issue to the states.

The Biden administration first approved delivering the abortion pill by mail in 2021 during the COVID-19 pandemic emergency. It finalized that rule this year in what supporters hoped could be a workaround for women in states with restrictive abortion laws.

Dr. Ingrid Skop, a Texas-based obstetrician and gynecologist whose testimony featured prominently in the judges’ ruling, said the ruling could protect women.

“Those promoting unsupervised DIY abortion pills clearly prioritize the deaths of unborn children over the health and safety of women,” she said. “I hope the FDA will once and for all be held accountable to its task of protecting the American public from this dangerous drug.”

Sen. Ron Wyden, Oregon Democrat, called the ruling “a political ploy to control women’s bodies.”

“The science is clear and a wealth of evidence demonstrates the drug’s safety and efficacy, which is why the FDA approved it more than 20 years ago. In fact, mifepristone has fewer complications than Tylenol,” he said.