Federal judge suspends FDA approval of abortion pill

In a case that could reshape pregnancy in America, a federal judge on Friday sided with anti-abortion groups seeking a nationwide ban on abortion pills, ruling that the Food and Drug Administration acted improperly in approving mifepristone in 2000. The ruling will go into effect in seven days if a stay is not granted by an appeals court or by the Supreme Court.

The ruling could affect people in every state, including those where abortion access is protected.

An FDA spokesperson said late Friday evening that it had appealed the ruling. “FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses,” the spokesperson said.

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President Biden also announced the Department of Justice had filed an appeal and would seek a stay, saying the court had “substituted its judgment for the FDA.” And Danco Laboratories — which makes a branded version of the drug, called Mifeprex — also said it would seek a stay and immediately appeal the ruling.

In issuing his decision, federal judge Matthew Kacsmaryk said that he did not “second-guess FDA’s decision-making lightly,” but said regulators “acquiesced on its legitimate safety concerns” due to political pressure at the time of the approval. Health care attorneys and public health experts have said the lawsuit is based on spurious claims that the FDA has not properly evaluated mifepristone as well as “a clear misreading” of federal law. The American Medical Association said the ruling “flies in the face of science and evidence and threatens to upend access to a safe and effective drug.”

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Shortly after the decision was handed down in Texas, a federal judge in Washington state released a decision that orders the FDA to ensure the continued availability of mifepristone. That judge, Thomas Rice, issued a preliminary injunction that would prevent the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”

The dueling decisions are poised to create a legal clash that could make its way to the Supreme Court.

“The FDA is caught in the middle, because whatever they do, they’re going to violate an order. So if you’re in a completely untenable situation, the only thing left for them to do is appeal the decision,” said Scott Lassman, an attorney who specializes in FDA regulatory law and policy. “I don’t think I’ve ever seen this happen before in terms of the FDA. I can’t remember seeing anything close to this happening.”

If Kacsmaryk’s ruling stands, it could end up severely limiting access to reproductive health care that’s long been proven safe and effective. Currently, the two-drug combination of mifepristone and misoprostol is thought to account for over half of abortions nationwide, and is also used to help patients experiencing miscarriages, which are incredibly common. A ban would likely force many to undergo more invasive procedures, rather than relying on pills. Some may not be able to access care at all.

Banning just mifepristone would mean that patients could still terminate pregnancies with misoprostol alone — a method used in many countries around the world — but the one-drug regimen is generally understood to be slightly less effective, to take longer, and to come with a higher chance of nausea and cramps.

“It’s going to lead to some disruption in care,” said Samantha Glass, a family physician and abortion care provider in Seattle, who teaches medical trainees how to terminate pregnancies with the group Physicians for Reproductive Health. “We have an established, safe, and effective regimen for medical abortion. And that would disrupt that regimen that we’ve been using, and would likely create barriers for patients.”

The Washington decision came in response to a case filed by a dozen Democratic attorneys general who sued to force the FDA to drop restrictions on mifepristone, pointing to the established safety and efficacy of the drug. The ruling in that case directly contradicts the decision from Kacsmaryk, who was appointed by former President Trump and is known for his ultra-conservative views. It’s widely thought that the plaintiffs chose his court over others because their complaint was more likely to prevail with this particular judge.

“Today’s ruling in the US District Court for the Northern District of Texas is a victory for all our patients,” the American Association of Pro-Life Obstetricians and Gynecologists, a plaintiff in the case, said in a statement.

For the FDA, the two decisions will create a thorny path forward.

“I have no idea how FDA is going to act on all of this, because it has never been seen before,” said Kirsten Moore, creator and director of the Expanding Medication Abortion Access project “These are both solutions in search of a problem.”

Lassman said he expected the agency to act in what it deems as the interest of public health, which would likely mean seeking to keep the medication on the market.

“The only way the FDA can comply with these contradictory opinions is to use its enforcement discretion,” explained Greer Donley, an associate law professor at the University of Pittsburgh, who is a national expert on abortion and the law. “The FDA likely won’t go after any manufacturer or anyone who sells the drug based on the opinion from the court in Washington, and also because it will be bad for public health.”

In the decades since the drug’s approval, the FDA has gradually eased some of its restrictions on how the pill is administered, including making it possible for patients to receive the pill by mail. Kacsmaryk criticized those moves in his ruling, saying the agency “took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls.”

Evan Masingill, the CEO of GenBioPro — one of pill’s makers — said in a statement that “decades of science support mifepristone’s safety and efficacy” and said the company is “confident in the legality of mifepristone’s approval.” The American College of Obstetricians and Gynecologists added that the drug’s “safety and efficacy is backed up by robust, evidence-based, clinical data and its observed use by millions of people with support from clinicians, including obstetrician–gynecologists.”

“Regardless of the opinion of one judge on this matter, mifepristone is a safe, effective part of comprehensive health care,” Iffath Abbasi Hoskins, president of ACOG, and Maureen Phipps, the organization’s CEO, said in a statement.

The outcome of the decisions could have ramifications in health care that stretch beyond abortion access. If the FDA’s approval is permanently suspended, it could also set a precedent for third parties challenging the FDA approval of vaccines and other medications.

“The biggest takeaway in the Texas opinion is that the judge said so very clearly that he was overruling the FDA’s scientific judgment, which makes this the first time a judge has removed a drug from the market over the objection of the FDA” and a drug’s maker, said Donley. “It opens the door to another politically motivated lawsuit to get a safe and effective drug off the market.”

Jeremy Levin, CEO of Ovid Therapeutics, said that if mifepristone’s approval is overturned, “the harm will not just be to women and their rights to have medical treatment. It won’t just be to the industry and its role in developing new medicines and creating a fundamental capability in the United States. It will now target the defenseless: Children who get vaccines that stop them from getting measles, mumps, and rubella — killers from the last age. You can fully expect a similar challenge from vaccine deniers.”

Sarah Owermohle and Ed Silverman contributed reporting. 

This story has been updated with additional information on the ruling, the Washington state decision, and other comment. 

Source: STAT