麻豆传媒

Mifepristone (Mifeprex) can remain on the market, a federal appeals court ruled late on Wednesday, but with temporary restrictions that align with the drug's original 2000 approval until the full case can be heard.

Prescriptions for mifepristone will again require an in-person visit with a physician, use will be limited to individuals no more than 7 weeks pregnant, and the drug can no longer be distributed by mail, the order appeared to suggest.

The appeals court decision partially overruled Friday's decision from Matthew Kacsmaryk, a federal judge of the Northern District of Texas, who had ordered that mifepristone's approval be overturned completely.

In Wednesday's decision, the three-judge panel of the U.S. Fifth Circuit Court of Appeals in New Orleans said the statute of limitations bars the plaintiffs -- Alliance for Hippocratic Medicine (AHM) and other anti-abortion physicians -- from challenging the FDA's 2000 approval. Yet they ruled it was not too late for the group to challenge the FDA's 2016 risk evaluation and mitigation strategies (REMS) program.

Under the REMS program, the FDA began a series of changes that increased access to mifepristone, including extending its indication until up to 10 weeks gestation in 2016 and making the drug permanently available by mail in 2021.

The appeals court found that AHM had not "sufficiently established" a rationale for challenging mifepristone's original approval, however the precise details of that ruling and how FDA will go about implementing them "remains to be seen," said Eva Temkin, JD, a former FDA attorney and partner at King & Spalding in Washington D.C., during an online press conference hosted by NARAL Pro-Choice America on Thursday.

The Fifth Circuit's order made one thing clear, said Temkin -- that the judges believe the plaintiffs have legal standing to bring a lawsuit challenging FDA's regulation of mifepristone. The judges included a copy of the Patient Agreement Form -- part of the mifepristone REMS -- on which the risks of mifepristone are highlighted, including the potential need for emergency care, the potential for treatment to fail, and the potential need for a surgical procedure should treatment fail or heavy bleeding occur.

Given the risks articulated on these FDA-approved forms, the agency "cannot deny that serious complications from mifepristone" can occur, the judges wrote.

The order also cited other examples of harm from mifepristone, wherein various patients became septic, required blood transfusions for hemorrhage, or required "surgical completion."

"As a result of FDA's failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone's harmful effects," the circuit judges wrote. "This harm is sufficiently concrete."

As to the particular question of whether, as the AHM argues, the FDA violated the 1873 Comstock Act -- which prohibited the mailing of any "article, instrument, substance, drug, medicine ... for producing abortion" -- by allowing mifepristone to be distributed by mail, the order is unclear.

"There's no ruling on Comstock," said Jennifer Dalven, JD, director of the ACLU Reproductive Freedom Project. "But there is very frightening language in the decision indicating where the court might be inclined to go."

Following the Texas ruling, the Biden administration and mifepristone's drugmaker Danco Laboratories earlier this week of the order from the Fifth Circuit Court, in order to extend the time until Kacsmaryk's decision took effect.

On Thursday afternoon, Attorney General Merrick Garland said in a press release that the Department of Justice "strongly disagrees" with the Fifth Circuit's decision and plans to seek emergency relief from the Supreme Court to "defend the FDA's scientific judgment and protect Americans' access to safe and effective reproductive care."

Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. While misoprostol alone is safe and effective, it is not as effective as the two-drug regimen.

Stakeholders Weigh In

The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) called the decision a "victory for our patients. "

"Since the drugs mifepristone and misoprostol were approved for use in chemical abortions in 2000, the FDA has repeatedly removed necessary safeguards meant to decrease the risk of serious harm to the women who consume them," AAPLOG said in a . Today's "order reinstating these safeguards for mifepristone is a first step towards reprioritizing women's health over the interests of the abortion industry and its allies within our profession."

Jack Resneck Jr., MD, president of the American Medical Association (AMA), expressed concern, calling the decision "a profoundly dangerous step backwards on access to mifepristone," in a press release.

"The appeals court elevated speculative pseudoscience over data and evidence, arbitrarily rolling back access to a safe and effective drug and leaving millions of women without a critical medication for reproductive healthcare." Resneck said. "The AMA fully supports the Department of Justice's request for emergency relief from the U.S. Supreme Court and will continue fighting to prioritize evidence-based decisions that maintain access to mifepristone."

Daniel Grossman, MD, director of Advancing New Standards in Reproductive Health at the University of California San Francisco, also expressed dismay over the appeals court's decision.

"Today's ruling is yet another reminder that the power to evaluate and approve medications on the market should remain with the FDA, not politically motivated judges," he said in a press release. "In restricting access to mifepristone, the [Fifth] Circuit ignored decades of evidence showing the safety and effectiveness of this medication provided past 7 weeks of pregnancy, via telehealth, and dispensed by mail. Junk science has no place in medicine."

Comment