Can the FDA just ignore the Texas judge's abortion pill ban?

The lone federal judge in Amarillo, Texas, ruled Friday evening that the Food and Drug Administration had improperly approved the abortion drug mifepristone in 2000 and purported to rescind the approval and ban the U.S. Postal Service from transporting the drug through the mail. Medication abortion, which typically uses a combination of mifepristone and misoprostol, is the most common method of terminating a pregnancy in the U.S., especially after the Supreme Court overturned Roe v. Wade in 2022.

The judge, U.S. District Judge Matthew Kacsmaryk, paused his ruling for seven days, until April 14, to give the Biden administration time to appeal the nationwide injunction on the sale of mifepristone. The Justice Department appealed the ruling right away, but some Democrats and legal analysts urged the FDA to just disregard Kacsmaryk's decision entirely.

"No matter what happens in seven days, I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I'm again calling on President Biden and the FDA to do just that," said Sen. Ron Wyden (D-Ore.), who chairs the Senate Finance Committee that oversees the FDA. "The FDA, doctors, and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America."

"This ruling is an extreme abuse of power" as well as "a mockery of our democracy and a mockery of our law," and if the courts uphold it, the executive branch should use its "enforcement discretion" to simply "ignore" the ruling, Rep. Alexandria Ocasio-Cortez (D-N.Y. ) agreed on CNN's State of the Union on Sunday. "I do not believe that the courts have the authority over the FDA that they just asserted, and I do believe that it creates a crisis."

The FDA and legal experts of all political persuasions said Kacsmaryk's ruling had significant problems, "from misstated science, to a long-expired statute of limitations, to a lack of standing," The Texas Tribune reports. But can the FDA really just ignore the ruling from a federal judge?

What are the commentators saying?

The ruling by Kacsmaryk, an appointee of former President Donald Trump well known for his strong anti-abortion views, "is a travesty — for women's health care, principles of democracy, notions of judicial impartiality, and the rule of law," Cardozo Law School professor Kate Shaw writes in The New York Times. "The Biden administration should be swift and forceful in its response," deploying "every tool available to highlight the lawlessness of what the judge has done and to limit any damage that may occur."

The White House should start with appealing the ruling, but it "must recognize that adherence to well-worn norms — for instance, an orderly appeals process — is less consistent with a principled commitment to the rule of law than more aggressive responses to lawlessness," Shaw said. And legally, the FDA would be well within its rights to "exercise its enforcement discretion" and not enforce Kacsmaryk's ruling.

Ocasio-Cortez pointed to a legal precedent called "agency nonacquiescence," which an article in the Maine Law Review defines as "the refusal by administrative agencies to follow the decisions of lower federal courts" — though the same article cautioned that nonacquiescence "implicates grave separation of powers concerns," and the "presumed benefits" may not "outweigh the harms that nonacquiescence presents to the judiciary and the development of administrative law."

Ignoring Kacsmaryk's "outrageous decision" could also backfire, Sen. Patty Murray (D-Wash.) told Politico. "I get the sentiment, because this is a truly infuriating situation," she said. "But the key thing that needs to happen right now is making sure this decision is quickly appealed and reversed in court." White House Press Secretary Karine Jean-Pierre agreed Monday. "We are ready to fight this," she said, but "as a dangerous precedent is set for the court to set aside the FDA's and expert judgment regarding a drug's safety and efficiency, it will also set a dangerous precedent for this administration to disregard a binding decision."

The Democratic lawmakers advising Biden and the FDA to ignore the ruling "are doing their jobs — it's their job to push the White House and agencies like the FDA," said NARAL President Mini Timmaraju. "We need lawmakers from blue states getting out there and calling public attention to this case and raising awareness."

What happens next?

"The FDA can use their enforcement discretion and say, even though the drug is unapproved, we're not going to go after anyone for selling, manufacturing or dispensing this unapproved drug," Greer Donley, a University of Pittsburgh law professor who studies FDA law, told The Texas Tribune. But unless a higher court intercedes, "in seven days, this will become an unapproved drug."

At the same time, "Judge Kacsmaryk is not all-powerful," Donley writes at Slate with fellow law professors David S. Cohen and Rachel Rebouche. Not only does the FDA retain "a huge amount of authority," but the ruling is narrower than what he would have you believe, affecting fewer people. It rests on shakier legal ground than generally understood, and its medical argument is meritless," they add. "To be clear, mifepristone is one of the most studied drugs in this country. The evidence shows that it is safer than penicillin, Viagra, and thousands of other drugs the FDA has approved. There is no evidence that the FDA acted improperly in approving mifepristone."

Still, "if the administration concludes that it must abide by the opinion from Judge Kacsmaryk, it should do so while beginning an expedited process of approving the drug again, a process that responds to the purported flaws that he identified with the FDA's previous approvals," Shaw writes at the Times.

And even if Kacsmaryk somehow wins, and the FDA complies, it won't end medication abortion. Americans already buy mifepristone from overseas, and his ruling "applies to just mifepristone, not misoprostol," she adds. "Studies show that misoprostol is safe and effective when used alone to end early pregnancies. But there is also some evidence that it creates worse cramping and other effects when used alone than when paired with mifepristone." So more pain, perhaps, but no real gain for Kacsmaryk or his allies.

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