Appeals court partially freezes Texas judge’s order that would have suspended FDA approval of medication abortion pill | Abortion

Appeals court partially freezes Texas judge’s order that would have suspended FDA approval of abortion pill

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A federal appeals court on Wednesday night froze parts of a Texas judge’s order who would have been suspended US Food and Drug Administration approval of a medical abortion drug.

But the court partially relented the request by the Justice Department and the drug manufacturer to delay the decision by United States District Judge Matthew Kacsmaryk, where the panel effectively made it harder to obtain the drug.

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

However, the US 5th Circuit Court of Appeals will vacate parts of the ruling that halted changes the FDA made to drug rules that expanded access to abortion pills. Those changes include the FDA’s end of the requirement to take mifepristone 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 as a particularly hot flashpoint in the abortion legal battle since the Supreme Court last year overturned Roe v. Wade precedent protecting abortion rights nationwide.

When his decision was released last week, Kacsmaryk delayed it taking effect for seven days to give the government time to appeal.

It is unclear whether the Justice Department or the drug’s maker, Danco Laboratories, will ask the Supreme Court to intervene at this point. Earlier this week, the DOJ indicated it would return 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 changed its use rules in ways that made it more readily available. the pill.

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

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

The judge said he would have granted the expedited appeal but would have issued an administrative stay on Kacmsaryk’s decision – a temporary hold that would last for a “short period of time” – and deferred the question of whether it should be frozen for a longer period of time judges hear expedited appeals.

That panel will be of a different make-up from the panel that considered the DOJ and Danco’s request to temporarily pause the decision.

Most of the 5th Circuit’s 42-page order focused on examining whether the plaintiffs faced procedural issues in bringing their case. The appeals court was sympathetic to a large portion of the plaintiffs’ allegations about the drug’s safety, which were rebuked by leading medical associations.

The 5th Circuit said the FDA’s current rules around the drug made for a “very unusual regime” because the agency “chose to remove doctors from prescribing and administering mifepristone.”

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

The FDA approved mifepristone after a four-year review process. It has been proven to be a safe and effective way to terminate pregnancy for more than two decades it has been on the market. But anti-abortion doctors and medical associations say the agency broke the law by not adequately considering the drug’s supposed risks.

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