The ruling could have far-reaching implications.
It’s been almost a year since Roe v. Wade was overturned, and abortion rights are continuing to be rolled back across the country. Abortion medication has been the target of the latest attacks, and two competing rulings from federal judges have placed one of the drugs used for medical abortion in jeopardy.
The “abortion pill” is thrown around a lot, but it’s actually two pills — mifepristone and misoprostol — that are taken in tandem to terminate pregnancies up to 10 weeks. The first one, mifepristone, has been under scrutiny lately. In November, it became the subject of a Texas lawsuit brought by the anti-abortion group Alliance Defending Freedom. The suit claimed the FDA didn’t properly study the risks of the drug before approving it in 2000, even though it has been safely used by millions since then.
What did the Texas ruling say about mifepristone?
On Friday night, U.S. District Judge Matthew Kacsmaryk ruled that the FDA rushed through the approval of mifepristone, writing, “FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” Kacsmaryk ordered a preliminary injunction on the medication and gave the government seven days to file an appeal, which the Biden administration did within hours of the ruling. The FDA and Danco Laboratories, the manufacturer of mifepristone, already appealed the ruling to the Fifth Circuit of Appeals, and Merrick Garland said in the statement that the Justice Department “will be appealing the court’s decision and seeking a stay pending appeal.”
The FDA, unsurprisingly, has pushed back against the ruling, saying in a statement it “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.”
What about the conflicting ruling in Washington?
The same day, a judge in Washington state ordered the FDA not to rescind its approval of the drug after a group of Democratic state attorneys general challenged the federal agency’s restrictions on dispensing mifepristone. They claimed the restrictions, which have been in place since the FDA approved the drug under the Risk Evaluation and Mitigation Strategy in 2000, are “burdensome” and “unnecessary.” U.S. District Court Judge Thomas Rice agreed, preventing the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.” But Rice said his ruling only impacts the 17 states and D.C. involved in the challenge, saying it would be “inappropriate” to issue a nationwide injunction — seemingly throwing a little bit of shade at Kacsmaryk’s ruling.
Does this mean mifepristone is illegal?
Kacsmaryk’s ruling has yet to go into effect, although unless the Fifth Circuit grants the FDA or Danco Laboratories emergency relief, access to mifepristone could be cut off as soon as the end of next week. However, because of the competing ruling out of Washington, and because the Texas ruling is already being challenged by the Biden administration, it’s likely the Supreme Court will need to step in. This would set the stage for another showdown on abortion rights in the Supreme Court.
How the ruling could go beyond the abortion pill
The Texas ruling is essentially second-guessing the FDA’s decision-making — and since it ruled the FDA’s approval of mifepristone wasn’t legally sound, that could impact access to the drug nationwide, not just in Kacsmaryk’s district or in Texas. It would also affect people living in states where abortion is not currently restricted.
But on CNN’s “State of the Union” on Sunday, Health and Human Services Secretary Xavier Becerra expressed concern that the ruling could have implications that go far beyond abortion, because of the way it goes after the FDA.
“You’re talking about every kind of drug. You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”
President Biden even stepped in. “The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” he said. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
Can the FDA just ignore the ruling?
Since Kacsmaryk’s ruling was handed down, there have been calls for the FDA to simply ignore it. On CNN, Rep. Alexandria Ocasio-Cortez said, ” believe that the Biden administration should ignore this ruling.” Similarly, Republican Rep. Nancy Mace also told CNN that she agrees with ignoring the ruling: “I support the usage of FDA-approved drugs even if we might disagree. It’s not up to us to decide as legislators or even the court system.”
The decision has opened up larger questions of whether the courts have the power to weigh in on the federal agency’s authority. In 1938, Congress gave the FDA the power to determine whether drugs are safe and effective. In 2014, drug company Zogenix sued the state of Massachusetts for trying to ban an opioid and won. The federal judge who decided the case wrote that if Massachusetts “were able to countermand the F.D.A.’s determinations and substitute its own requirements, it would undermine the F.D.A.’s ability to make drugs available to promote and protect the public health.” Dr. Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School, told the New York Times that the Texas decision about mifepristone “represents judicial interference in really the core function of the F.D.A. and handcuffs F.D.A. in making future safety and effectiveness decisions.”
But simply ignoring the decision might not be an option, the Department of Health and Human Services warns. “As dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision,” HHS spokesperson Kamara Jones tweeted.
