The Biden administration on Friday asked the Supreme Court to review a lower court opinion that made the abortion pill available but placed restrictions on the drug’s distribution.
In a cert petition, the Justice Department argued the loss of access to mifepristone, the abortion drug, would be “damaging for women and healthcare providers around the Nation.” The government called mifepristone the “best method” to terminate early pregnancies and pointed to the Food and Drug Administration’s previous determination that the drug is safe and effective.
“The effect of the lower court’s decisions would be to compel FDA to return to a pre-2016 regulatory regime that imposes restrictions on distribution that FDA has found to be unnecessary and unjustified,” lawyers for the Justice Department wrote.
The filing came hours after abortion pill manufacturer Danco Laboratories filed its own petition seeking Supreme Court review of the lower court ruling.
Last month, a three-judge panel on the 5th U.S. Circuit Court of Appeals in New Orleans rolled back FDA deregulation of the abortion pill. The ruling ended the availability of Mifepristone by mail, required that it is administered in a physician’s presence, and also stated that the drug can only be used through the seventh week of pregnancy, versus the previous 10 weeks.
Judge Jennifer Walker Elrod wrote in the ruling that “In loosening mifepristone’s safety restrictions, the FDA failed to address several important concerns about whether the drug would be safe for the women who use it.”
The Justice Department called it an “unprecedented” decision that contradicted the FDA’s expert judgment.
However, the Supreme Court previously issued an injunction temporarily keeping the Biden administration’s deregulated rules in place while the case proceeds through court. Mifepristone currently remains available in states where abortion is legal under the FDA-approved conditions.
Mifepristone, known by the brand name Mifeprex, is a pill taken with misoprostol in a two-drug regimen that first deprives an unborn baby of hormones it needs to stay alive and then causes cramps and contractions to expel the dead fetus from the mother’s womb.
According to Danco, more than 5 million women have used Mifeprex in the United States since the FDA approved its use in 2000. The drug is 97% effective in terminating early pregnancy, although the company says 3% of women who take it will require surgical intervention for ongoing pregnancy, heavy bleeding, incomplete expulsion or other reasons such as patient request.
“The FDA actions at issue were well supported by extensive safety and effectiveness data from clinical trials and decades worth of real-world experience in millions of patients,” Danco said in a news release. “The changes in 2016 and 2021—approved by FDA after careful analysis — have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits.”
Alliance Defending Freedom, which filed the Texas lawsuit against the FDA’s approval of Mifepristone, previously said the 5th Circuit decision was a “victory for women’s health.”
“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 ADF Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice. “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 from the chemical abortion drug regimen.”