UNITED STATES

DOJ will take emergency dispute over medication abortion rules to the Supreme Court

Apr 13, 2023, 10:30 AM

SCOTUS ruling on mifepristone...

FILE: Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. (Evelyn Hockstein, Reuters via CNN)

(Evelyn Hockstein, Reuters via CNN)

Originally Published: 13 APR 23 02:00 ET
Updated: 13 APR 23 12:05 ET

(CNN) — The Justice Department will take an emergency dispute over medication abortion drugs to the Supreme Court, Attorney General Merrick Garland said Thursday.

Garland’s announcement comes after a federal appeals court overnight froze parts of a Texas judge’s order that would have suspended the US Food and Drug Administration’s approval of a medication abortion drug. But the US 5th Circuit Court of Appeals only partially granted the request by the Justice Department and the drug’s manufacturer to put US District Judge Matthew Kacsmaryk’s ruling on hold, with the appellate panel effectively making the drug harder to obtain by leaving in place aspects of Kacsmaryk’s ruling that will reverse moves by the FDA that expanded access to medication abortion pills.

In the new statement, Garland indicated that the Justice Department will ask the Supreme Court to intervene now in the emergency dispute over how the FDA has approached the drug, mifepristone.

“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Garland said, referring to an appellate ruling that left parts of the judge’s ruling in place while reinstating the FDA’s approval for the drug, mifepristone.

He added, “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital in person to obtain the drug.

The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It’s possible however that even with the ruling in effect, some providers could go “off label” and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.

Danco Laboratories, a mifepristone manufacturer that intervened in the case to defend the drug’s approval, has not yet said whether it will also seek emergency relief from the Supreme Court.

CNN Supreme Court analyst Steve Vladeck who is a professor at the University of Texas School of Law said the ruling “froze the craziest, most harmful parts of Kacsmaryk’s ruling,” but that access to mifepristone is still significantly limited.

“The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling,” he wrote on Twitter. “But it *didn’t* freeze Kacsmaryk’s block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail.”

Medication abortion, which makes up the majority of abortions obtained in the United States, has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned Roe v. Wade precedent that protected abortion rights nationally.

Last Friday, Kacsmaryk issued a ruling that would have halted the FDA’s 23-year-old approval of the drug, mifepristone. Under the appeals court’s new order, the approval will stay in effect and the drug will remain on the market while an expedited appeal plays out.

However, the US 5th Circuit Court of Appeals is leaving in place parts of the ruling that halted changes the FDA made to the rules around the drug that expanded access to medication abortion pills. Those changes include the FDA’s end of the requirement that mifepristone be picked up in person, the agency’s approval of a generic version of the drug, and adjustments the FDA made to the label instructions for the drug’s use.

When issuing his ruling last week, Kacsmaryk delayed it taking effect by seven days to give the government time to appeal.

In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

A split 5th Circuit panel said in its new order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill’s defenders had not shown that they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s more recent regulatory actions toward mifepristone.

The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

The judge said she would have granted the expedited appeal but would have issued an administrative stay on Kacmsaryk’s ruling — a temporary hold that would have lasted a “brief period of time” — and deferred the question of whether it should be frozen longer term to the judges hearing the expedited appeal.

That panel will be a different make-up from the panel that considered the DOJ and Danco’s request that the ruling be paused in the interim.

Much of the 5th Circuit’s 42-page order was devoted to analyzing whether the plaintiffs face procedural issues in bringing their case. The appeals court was sympathetic to a large swath of the plaintiffs’ allegations about the drug’s safety, which have been rebuked by leading medical associations.

The 5th Circuit said the current FDA rules around the drug made for “an exceedingly unusual regime” because the agency “chose to cut out doctors from the prescription and administration of mifepristone.”

“In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way,” the panel said.

The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it’s been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug’s supposed risks.

This story and headline have been updated with additional details.

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DOJ will take emergency dispute over medication abortion rules to the Supreme Court