HomeHealth Care NewsCourt Orders FDA to Restore Abortion Pill Safety Measures

Court Orders FDA to Restore Abortion Pill Safety Measures

A three-judge panel of the Fifth Circuit Court of Appeals unanimously ruled the abortion drug mifepristone can stay on the market, but the Food and Drug Administration (FDA) must restore safety protections removed over the years, on August 16.

The decision in the case, Alliance for Hippocratic Medicine v. FDA, came after U.S. District Court Judge Matthew Kacsmaryk of the Northern District of Texas stayed the FDA’s initial approval of mifepristone in 2000 entirely, on April 7. The Biden administration quickly appealed Kacsmaryk’s order and the U.S. Supreme Court intervened, allowing the drug to stay on the market as the case advances through the judicial system.

The plaintiffs or the Biden administration could appeal to the U.S. Supreme Court. The Biden administration indicated in a statement that it will ask for the Supreme Court to review the decision, stating that the ruling “undermines FDA’s scientific, independent judgment and reimposes onerous restrictions on access to safe and effective abortion.”

‘Restore … Safeguards for Women’

If the appeals court decision stands, mifepristone can not be Kaczmarek’s sent through the mail, or prescribed after seven weeks of pregnancy; it must be prescribed by a physician, after a face-to-face visit, and adverse effects must be reported.

The appeals court ruling is a victory, says Alliance Defending Freedom (ADF) Senior Counsel and Vice President Erin Hawley, in a press release.

“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,” said Hawley. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard … without regard to women’s health or the rule of law.”

Mifepristone will be available by mail in some states due to a decision in another case, Washington v. FDA. Within an hour of the Kacsmaryk decision, a federal district judge for the Eastern District of Washington ordered the FDA not to interfere with the availability of mifepristone in 17 states and the District of Columbia.

Not Far Enough

While the appellate decision was unanimous, in a separate opinion Judge James C. Ho said the court should void the FDA’s approval of the drug 23 years ago.

“The FDA approved mifepristone under its Subpart H regulations,” wrote Ho. “But Subpart H only authorizes the FDA to approve drugs that “treat [] serious or life-threatening illnesses.” 21 C.F.R. § 314.500. And pregnancy is plainly not an illness.”

The government argued it is too late to challenge a drug approval made in 2000, but Ho noted the clock restarts when the FDA changes regulations, as it did in removing safety precautions in 2016 and in 2021.

Ho also addressed conscience and “aesthetic injury,” which refers to someone being forced to witness an activity that interferes with the joy of viewing something, similar to the Sierra Club objecting to the destruction of trees or wildlife.

“The FDA’s approval of mifepristone creates a substantial risk that Plaintiffs will be forced to participate in the abortion process,” Ho wrote. “The FDA has approved the use of a drug that threatens to destroy the unborn children in whom Plaintiffs have an interest. And this injury is likewise redressable by a court order holding unlawful and setting aside approval of that abortifacient drug. I see no basis for allowing Article III standing based on aesthetic injury when it comes to animals and plants—but not unborn human life.”

Marketing Can Continue

While the case is under appeal, mifepristone will continue to be available, says Genevieve Marnon, legislative director for Right to Life Michigan.

“I do believe the Supreme Court will hear this case, but unfortunately, the status quo continues,” said Marnon. “Until then, abortion providers will still have an opportunity to expand their mail-order abortion business and leave women in harm’s way,” said Marnon. “Women will still be able to receive abortion pills via telemedicine with no physical exam, no follow-up, and nowhere to turn if there are complications except to the emergency room.”

Marnon was encouraged by Judge Ho’s concurring opinion.

“It was excellent! I hope and pray that the SCOTUS will give it deference as his legal arguments were in my opinion spot on,” said Marnon. “The original approval of Mifeprex (mifepristone) was unlawful, and should be reviewed, and hopefully the Supreme Court will agree that the abortion pill should be removed from the market. That said, I would have preferred if the sentiments expressed by Judge Ho had been affirmed by the rest of the panel of judges.”

The Supreme Court will undoubtedly need amicus briefs and more pointed oral arguments to decide whether mifepristone should be pulled from the market, says Marnon.

“This is such a politically charged issue, and the SCOTUS has recently been through such a rough time over Dobbs—including the Biden Administration allowing a sitting Justice to be hassled, threatened, and picketed at his home,” said Marnon. “I wonder if there is enough willpower to actually pull the abortion pill off the market now that there have been 23 years of reliance on it.”

AnneMarie Schieber (amschieber@heartland.org) is the managing editor of Health Care News.

AnneMarie Schieber
AnneMarie Schieber
AnneMarie Schieber is a research fellow at The Heartland Institute and managing editor of Health Care News, Heartland's monthly newspaper for health care reform.


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