A federal appeals court has upheld parts of the Food and Drug Administration’s decades-old approval of the abortion pill, mifepristone, in a divided ruling that found the FDA ignored safety concerns as it expanded access to the drug — through the mail and up to 10 weeks of pregnancy — in 2016. File Photo by Bill Greenblatt/UPI |
License PhotoAug. 16 (UPI) — A federal appeals court has upheld parts of the Food and Drug Administration‘s decades-old approval of the abortion pill mifepristone in a divided ruling that also found the FDA ignored safety concerns as it expanded access to the drug in 2016.
Mifepristone will remain on the market for now, after a three-judge panel on the conservative-leaning U.S. 5th Circuit Court of Appeals agreed Wednesday that the FDA’s 2016 rules expanding access to the abortion pill — through the mail and up to 10 weeks of pregnancy — should be reversed.
“This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016,” the 5th Circuit’s opinion said Wednesday. Mifeprex is the drug name for mifepristone, manufactured by the company Danco Laboratories.
The panel said the generic version of mifepristone, made by GenBioPro, “will also be available under the same conditions as Mifeprix.”
The case, which originated in Texas, challenged the FDA’s approval of the abortion drug in 2000, as well as the agency’s subsequent regulatory changes. Mifepristone blocks the hormone progesterone and misoprostol, which induces contractions.
In 2016, the FDA expanded mifepristone’s window to terminate pregnancies from seven weeks gestation to 10 weeks, while dropping the number of doctor visits from three to one. In 2019, the agency approved a generic form of mifepristone. And in 2021, the FDA allowed the drug to be administered via telehealth and delivered by mail.
A preliminary ruling in April suspended mifepristone’s FDA approval, as U.S. District Judge Matthew Kacsmaryk ruled the abortion drug’s approval process 23 years ago had been rushed. The Justice Department promptly filed an emergency appeal of Kacsmaryk’s order to the 5th Circuit.
In its ruling Wednesday, the 5th Circuit panel of judges — Jennifer Walker Elrod, James Ho and Cory Wilson — said it would reinstate the FDA’s original rules, which limit mifepristone to seven weeks of pregnancy and require it be dispensed in person, while noting a Supreme Court ruling that requires full access to mifepristone during ongoing legal challenges.
The 5th Circuit also found that the group of doctors, who originally sued in Texas over the FDA’s original approval of mifepristone in 2000, waited too long.
While the Justice Department is expected to appeal the decision, abortion rights groups applauded Wednesday’s ruling.
“The FDA ignored science and its own rules when it rubber-stamped Democrats’ reckless mail-order abortion scheme,” Katie Daniel, state policy director of Susan B. Anthony Pro-Life America, said in a statement. “Mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year.”
Alexis McGill Johnson, president of Planned Parenthood Federation of America, disagreed and warned 5th Circuit’s ruling “makes it clear that mifepristone’s approval is very much still at risk, as is the FDA’s independence.”
Late Wednesday the White House issued a statement from Vice President Kamala Harris, who said the Biden administration “strongly” disagrees with the 5th Circuit decision.
“As I have continually said, this lawsuit is a threat to a woman’s freedom to make decisions about her own body and another step towards the ultimate goal of a nationwide abortion ban,” Harris said in the statement. “It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA. Americans across the country should be able look in their medicine cabinets and know that FDA-approved medication prescribed by a doctor will remain available. This decision stands between doctors and their patients.”
