Evelyn Hockstein/Reuters
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, January 13, 2023

A federal appeals court late Wednesday night 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 court 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 panel effectively making the drug harder to obtain.

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.

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.

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

It is unclear if the Justice Department or the drug manufacturer, Danco Laboratories, will ask the Supreme Court to intervene at this point. Earlier this week, the DOJ indicated it would turn to the high court if the 5th Circuit did not act by noon CT on Thursday.

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.

Source: https://edition.cnn.com/2023/04/13/politics/abortion-pill-mifepristone-appeals-court/index.html