Washington, D.C. Newsroom, Sep 12, 2023 / 08:45 am

President Joe Biden’s Department of Justice is asking the U.S. Supreme Court to overturn an appellate court ruling that ordered the Food and Drug Administration to put up safeguards that would regulate the use of an abortion pill.

The DOJ filed the appeal on Friday to prevent limits on the abortion pill mifepristone. The drug has FDA approval to kill a preborn child up to the 10th week of pregnancy. It is commonly taken with another pill, misoprostol.

Although the pill has been on the market since 2000, an August ruling from the 5th U.S. Circuit Court of Appeals found that the Food and Drug Administration’s deregulation of mifepristone in 2016 and later years did not follow legally required safety protocols. With this ruling, the court ordered the FDA to return to the rules that were in effect prior to 2016 to ensure the drug is administered safely.

Under post-2016 rules, doctors are allowed to prescribe the abortion-inducing drug remotely through televisits and women are allowed to receive the drug through the mail. If the appellate court ruling goes into effect, both of these practices would be blocked. Rather, the prescription would require at least one in-person doctor’s visit and the drug would need to be picked up in person.

Danco Laboratories LLC, which distributes the abortion pill mifepristone under the brand name Mifeprex, also petitioned the Supreme Court to overturn the appellate court ruling. In a statement, the company accused the courts of imposing restrictions on the drug simply because they do not like it.

“The case presents a serious question: whether courts can disregard constitutional and statutory limits on judicial review of agency action to overrule agency decisions that they dislike,” the statement read. “Danco asks the court to grant review of both the determination that doctors who do not prescribe or want to prescribe Mifeprex have standing and the determination that FDA acted unreasonably in approving the changes in 2016 and 2021 despite the extensive study and other data supporting those decisions.”

Danco’s statement insisted that the company is “confident in the safety and effectiveness of Mifeprex” and that “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.”

In its ruling, the 5th U.S. Circuit Court of Appeals found that the “FDA failed to address several important concerns about whether the drug would be safe for the women who use it” when it eliminated the safeguards.

“[The FDA] failed to consider the cumulative effect of removing several important safeguards at the same time,” the court found. “It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of nonfatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

Despite the appellate court ruling, the abortion pill is still available under the post-2016 rules as the lawsuit awaits action from the U.S. Supreme Court. In April, the Supreme Court ruled 7-2 that mifepristone would remain available under the post-2016 regulations for the duration of the litigation process.

The Supreme Court can decide to allow the appellate court’s ruling to go into effect or take up the appeal itself.

“Mifeprex will continue to be available under the current FDA-approved conditions, which include use in pregnancy up to 10 weeks’ gestation, with prescribing after in-person or telehealth examination and dispensing by certified health care professionals, brick-and-mortar pharmacies, or mail-order pharmacies,” the Danco statement read.

Alliance for Hippocratic Medicine, a pro-life organization, sued the FDA over its initial approval of mifepristone in 2000 and the subsequent deregulation of the pill in 2016 and later, claiming that the agency failed to follow proper safety protocols.

The appellate court rejected the argument that the 2000 approval of the drug violated federal law but agreed with the argument that the 2016 deregulation and subsequent deregulation failed to follow proper safety protocol.