The Supreme Court agreed on Dec. 13 to hear the Biden administration’s defense of regulatory moves related to mifepristone, a pill used for abortions.
The court’s decision in the heavily litigated case could affect the availability of the drug. In 2016, prescription rules were loosened, and in 2021, the government allowed prescriptions to be sent by mail. Opponents of the abortion pill argue that these decisions put women at risk.
Although a lower court had blocked the sale of mifepristone after finding that the process involved in approving the drug was legally flawed, the Supreme Court countermanded that order in April, allowing sales to continue.
A medication abortion generally involves the use of mifepristone, which blocks progesterone, a hormone, and misoprostol, which induces contractions. Misoprostol isn’t an issue in the current litigation.
The case is the Supreme Court’s most important abortion-related case since its decision in June 2022 in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and found that there was no right to abortion in the U.S. Constitution. The ruling returned the regulation of abortion to the states.
The decision came in unsigned orders released by the court. No justices dissented. The court didn’t explain its decision. At least four of the nine justices have to vote to grant a petition for it to move forward to the oral argument stage.
The court agreed to hear the cases of Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM, but turned down another petition in AHM v. FDA.
Danco Laboratories makes the abortion pill that is also known as Mifeprex and RU-486.
The mission statement page on the AHM website states that the group “upholds and promotes the fundamental principles of Hippocratic medicine.”
“These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing health care with the highest standards of excellence based on medical science,” it states.
A federal district judge in April found that the FDA was wrong to approve mifepristone for public use in 2000 and that the agency had stonewalled opponents of the drug for years. The judge also found that the FDA had improperly lifted restrictions related to accessing the drug.
In 2016, the agency changed the drug’s label, extending the cutoff for its use from 49 days of gestation to the 70-day mark. At the same time, the agency allowed the drug to be prescribed by nondoctors and with only one in-person visit, and halted the requirement that prescribers report nonfatal adverse events related to the drug.
In 2019, the FDA approved a generic version of the drug. In 2021, the agency allowed patients to receive the drug by mail instead of having to pick it up in person from a specially certified health care provider.
The U.S. Department of Justice (DOJ) appealed the judge’s decision, but the U.S. Court of Appeals for the 5th Circuit refused to block most of the order. The 5th Circuit held that the FDA’s actions in 2016 and 2021 were probably unlawful—a finding that the FDA and Danco filed petitions asking the Supreme Court to review.
On Aug. 16, the 5th Circuit upheld the restrictions on the abortion pill imposed by the district judge, finding that the FDA failed to give proper consideration to public safety concerns when approving it.
The DOJ appealed to the Supreme Court, which issued a stay, temporarily blocking the order until April 19. The Supreme Court extended the stay to April 21; then, on that day, it again blocked the order, allowing mifepristone to remain on the market. Conservative Justices Clarence Thomas and Samuel Alito voted against extending the stay.
In September, U.S. Solicitor General Elizabeth Prelogar urged the Supreme Court to act, saying that the 5th Circuit’s ruling was the first time that a court has second-guessed the FDA’s “expert judgment” in approving medication.
If the ruling remains intact, it “would impose grave harms on the government, mifepristone’s sponsors, women seeking medication abortions, and the public,” she said at the time.
The attorney for the Alliance for Hippocratic Medicine shared her thoughts after the Supreme Court unveiled its new decision.
“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions,” Erin Hawley, senior counsel at the Alliance Defending Freedom, told The Epoch Times by email.
“We urge the Supreme Court to do the same. The FDA has harmed the health of women and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen. Like any federal agency, the FDA must rationally explain its decisions. Yet its removal of common-sense safeguards—like a doctor’s visit before women are prescribed chemical abortion drugs—does not reflect scientific judgment but rather a politically driven decision to push a dangerous drug regimen.”
Associate Attorney General Vanita Gupta at the Justice Department weighed in on the court’s decision.
“We are glad that the Supreme Court has agreed to hear this important case,” Ms. Gupta said in a statement.
“While the litigation continues, the stay the Court entered earlier this year means that mifepristone will remain available under the conditions approved by the FDA based on its expert scientific judgment. The Department of Justice will not cease its efforts to defend the FDA’s authorities and expertise in this area.”
Danco’s attorney Jessica Ellsworth of Hogan Lovells in Washington didn’t respond by press time to a request for comment.
The court hasn’t yet scheduled oral arguments. The two appeals, FDA v. AHM and Danco v. AHM, have been consolidated and will be heard together.
